# https://qualitysmartsolutions.com/ llms-full.txt ## Global Compliance Solutions [Skip to content](https://qualitysmartsolutions.com/#content) GUIDING YOU THROUGH GLOBAL REGULATIONS # Navigate compliance with clarity and confidence. Regulatory compliance doesn’t need to slow you down. We walk you through exactly what’s needed to get approved and stay compliant in Canada, the U.S., and beyond. [Explore our services](https://qualitysmartsolutions.com/#solutions_industry) [Schedule a call](https://qualitysmartsolutions.com/#enqy_form_sub) ## Trusted by leading companies ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/plantful.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/inner-armour.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/enzymedia.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2024/04/Hydralyte.webp) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/bausch.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/hmm.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/jamieson.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/unilever.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/biosteel.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2024/04/BANG-Rainbow-Unicorn-Logo.webp) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/optimum.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/smarty-pants.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/vital-proteins.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/vitacup.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/nestle.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/neocell.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/amazing-grass.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/smarty-pants.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/vital-proteins.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/vitacup.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/nestle.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/neocell.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/amazing-grass.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/plantful.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/inner-armour.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/enzymedia.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2024/04/Hydralyte.png) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/bausch.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/hmm.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/jamieson.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/unilever.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/smarty-pants.jpg) ## Helping businesses meet global compliance, one step at a time. With thousands of submissions behind us, we know what regulators look for. We use that experience to guide you through the process with clarity and confidence. ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/customer.webp) 3,500+ Clients guided to market ![](https://qualitysmartsolutions.com/wp-content/uploads/2026/03/projects_completed.webp) 60,000+ Projects completed ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/countries.webp) 74 Global markets navigated ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/expertise.webp) 19+ Years in compliance ## Solutions for every industry We give your business the knowledge and support to choose the right path, prepare strong submissions, and meet global standards. ![](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/food-and-bevarges.jpg) Food and Beverage In Canada, we support front-of-package labelling, Nutrition Facts Table creation, French translation, supplemented and novel food submissions, and SFCR licensing. For U.S. compliance, we help with facility registration, food label reviews, and FCE registration. [Explore more](https://qualitysmartsolutions.com/services/industry-food-beverages/%20) ![](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/ingridents-qss.jpg) Ingredients We help you meet regulatory requirements for ingredients in Canada, the U.S., Europe, Australia, and other global markets. Our support includes GRAS self-affirmation, GRAS notifications, novel food applications, safety assessments, and ingredient classification. [Explore more](https://qualitysmartsolutions.com/services/industry-ingredients/%20) ![](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/cosmetics-qss.jpg) Cosmetics In Canada, we help with cosmetic notifications, label compliance, French translation, and Canadian Cosmetic Agent services. In the U.S., we support MoCRA product listing, facility registration, manufacturer inspections, and safety substantiation. [Explore more](https://qualitysmartsolutions.com/services/industry-cosmetics/%20) ![](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/otc-drugs.jpg) OTC Drugs Our team supports Canadian drug compliance through DIN registration, NDS and ANDS submissions, and DEL applications. For U.S. compliance, we help with Drug Establishment Registration and Renewal, Drug Listing (DRLS), and National Drug Code (NDC) registration. [Explore more](https://qualitysmartsolutions.com/services/industry-otc-drugs/%20) ![](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/medical-devices.jpg) Medical Devices We support Canadian requirements including MDL, MDEL, and SaMD registration. For U.S. compliance, we guide you through 510(k) submissions, facility registration, FURLS listing, IVD and SaMD registration, and PMA pathways. [Explore more](https://qualitysmartsolutions.com/services/industry-medical-devices-canada-usa/%20) ![](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/dietary-suppliments.jpg) Dietary Supplements & NHPs We help with [NHP licensing](https://qualitysmartsolutions.com/services/canada-nhp-licensing/), site licences, and homeopathic submissions in Canada, along with [dietary supplement](https://qualitysmartsolutions.com/services/usa-dietary-supplements-compliance/) compliance in the U.S., including facility registration, NDINs, label reviews, and Supplement Facts Panels. ![](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/Veterinary-Health-Products.jpg) Veterinary Health Products We help you register VHPs with Health Canada, meet label and packaging requirements in both English and French, and act as your Canadian representative for regulatory purposes. [Explore more](https://qualitysmartsolutions.com/services/industry-veterinary-health-products/%20) ![](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/other-products.jpg) Other Products We support [cannabis](https://qualitysmartsolutions.com/services/industry-cannabis/) licences, [homeopathic](https://qualitysmartsolutions.com/services/industry-homeopathic-products/) medicines, and facility audit readiness, helping you prepare the right documentation and meet evolving compliance requirements. ## Compliance across regions We help businesses navigate regulatory systems in Canada, the U.S., and other key global markets. [![](https://qualitysmartsolutions.com/wp-content/uploads/2025/08/canada-flag.webp)\\ \\ **Canada**\\ \\ Licensing and compliance for NHPs, foods, cosmetics, OTC drugs, ingredients, medical devices, and VHPs\\ \\ ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/08/wright-arrow.webp)](https://qualitysmartsolutions.com/services/health-canada-compliance/) [![](https://qualitysmartsolutions.com/wp-content/uploads/2025/07/united-states.webp)\\ \\ **United States**\\ \\ Support for dietary supplements, food, cosmetics, OTC drugs, ingredients, and medical device registration\\ \\ ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/08/wright-arrow.webp)](https://qualitysmartsolutions.com/usa-compliance/) [![](https://qualitysmartsolutions.com/wp-content/uploads/2025/07/european-union.webp)\\ \\ **European Union (EFSA)**\\ \\ Novel food, food additive, and traditional food applications for EU market entry\\ \\ ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/08/wright-arrow.webp)](https://qualitysmartsolutions.com/european-union-compliance/) [![](https://qualitysmartsolutions.com/wp-content/uploads/2025/07/australia.webp)\\ \\ **Australia (TGA & FSANZ)**\\ \\ Regulatory support for new substances and product submissions\\ \\ ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/08/wright-arrow.webp)](https://qualitysmartsolutions.com/australia-compliance/) [![](https://qualitysmartsolutions.com/wp-content/uploads/2025/08/united-kingdom-1.webp)\\ \\ **United Kingdom (MHRA & FSA)**\\ \\ Novel food submissions and product compliance for the UK\\ \\ ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/08/wright-arrow.webp)](https://qualitysmartsolutions.com/uk-compliance/) [![](https://qualitysmartsolutions.com/wp-content/uploads/2025/07/new-zealand.webp)\\ \\ **New Zealand (FSANZ)**\\ \\ Guidance for FSANZ novel food applications and compliance requirements\\ \\ ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/08/wright-arrow.webp)](https://qualitysmartsolutions.com/australia-compliance/) [![](https://qualitysmartsolutions.com/wp-content/uploads/2025/07/china.webp)\\ \\ **China (CFDA)**\\ \\ Entry support and regulatory guidance for CFDA-compliant products\\ \\ ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/08/wright-arrow.webp)](https://qualitysmartsolutions.com/china-compliance/) [![](https://qualitysmartsolutions.com/wp-content/uploads/2025/07/flag.webp)\\ \\ **Mexico**\\ \\ Support for labelling and regulatory pathways for products sold in Mexico\\ \\ ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/08/wright-arrow.webp)](https://qualitysmartsolutions.com/mexico-compliance/) ## What our clients say We work closely with businesses of all sizes to guide them through complex regulatory processes. Here’s what some of them have shared. “I have been working with Quality Smart Solutions since starting my brand and I am extremely impressed with their attention to detail, knowledge, and fast turnaround time. I look forward to working with them for many years to come.” Aeryon Wellness “Their team was professional, knowledgeable, and efficient, making the process smooth and stress-free. Highly recommend their services!” Real House Team “If you need an amazing, reliable agency, you need to deal with them. Great consultants and amazing customer service.” Michael Zakini [Read more reviews](https://search.google.com/local/writereview?placeid=ChIJ01GKsQhhK4gRgvKaYS7GY0Q) ## How we help you succeed Proven expertise Our team includes toxicologists, scientists, and former regulatory agency experts who understand the process inside and out. Guidance from start to finish We help you make informed decisions at every stage, from assessment to submission. Efficient, reliable support We take a practical, hands-on approach to help you stay organized, avoid delays, and meet your deadlines with confidence. ## Latest news and updates Explore regulatory updates, expert articles, and events we’re attending, all in one place. [![FDA proposed rule addressing foreign drug manufacturer and distributed manufacturing registration](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/FDA-Drug-Manufacturing-Registration.jpg)\\ \\ - July 15, 2026\\ \\ **FDA Proposes Rule to Close Registration Gap for Foreign Drug Manufacturers**](https://qualitysmartsolutions.com/news/fda-proposes-rule-to-close-registration-gap-for-foreign-drug-manufacturers/) [![TikTok Shop dietary supplement compliance requirements displayed on a mobile phone screen](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/TikTok-Shop-dietary-supplement-rules.jpg)\\ \\ - July 13, 2026\\ \\ **Selling Dietary Supplements on TikTok Shop: A Compliance Requirements Guide**](https://qualitysmartsolutions.com/blog/selling-dietary-supplements-on-tiktok-shop-a-compliance-requirements-guide/) [![Veterinary health product registration in Canada for pet health companies](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/VHP-registration-in-Canada.jpg)\\ \\ - July 11, 2026\\ \\ **VHP Registration in Canada: What Pet Health Companies Need to Know**](https://qualitysmartsolutions.com/blog/vhp-registration-in-canada-what-pet-health-companies-need-to-know/) [View more resources](https://qualitysmartsolutions.com/resources/) 0/5 (0 Reviews) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Claims Classification Guide [Skip to content](https://qualitysmartsolutions.com/blog/therapeutic-claim-vs-non-therapeutic-claim-whats-the-difference-and-when-can-i-use-them#content) # Therapeutic vs. Non-Therapeutic Claims Classification Guide - January 24, 2022 Last updated: January 18, 2024 - Tags:[Cosmetic](https://qualitysmartsolutions.com/tag/cosmetic/), [Drug](https://qualitysmartsolutions.com/tag/drug/), [Natural Health Product](https://qualitysmartsolutions.com/tag/natural-health-product/) - [Blog](https://qualitysmartsolutions.com/blog/) Therapeutic vs. Non-Therapeutic Claims Classification Guide - January 24, 2022 - [Cosmetics](https://qualitysmartsolutions.com/topic/cosmetics/), [Natural Health Products (NHPs)](https://qualitysmartsolutions.com/topic/natural-health-products-nhps/) - [Cosmetic](https://qualitysmartsolutions.com/tag/cosmetic/), [Drug](https://qualitysmartsolutions.com/tag/drug/), [Natural Health Product](https://qualitysmartsolutions.com/tag/natural-health-product/) ![](https://qualitysmartsolutions.com/wp-content/cache/flying-press/gravatar-c8c2742d4b2e.png) [Andrew Lau](https://qualitysmartsolutions.com/blog/therapeutic-claim-vs-non-therapeutic-claim-whats-the-difference-and-when-can-i-use-them#gbio) ## In This Article: ![](https://qualitysmartsolutions.com/wp-content/uploads/2022/01/Therapeutic-Claim.jpg) ### **What is a claim?** A claim is a representation for sale. It can be presented as “a word, a sentence, a picture, a symbol, a paragraph or an implication on product labels, package inserts or advertisements, including company websites”. It explains what the product is for and what it does. There are two types of health claims: Therapeutic Claim and Non-Therapeutic Claim. Depending on the health claims, your product can be classified as a **[cosmetic](https://qualitysmartsolutions.com/cosmetics-regulations-compliance-services/)**, **[NHP](https://qualitysmartsolutions.com/nhp-licensing-and-consulting-experts/)**, or **[drug](https://qualitysmartsolutions.com/otc-drug-compliance-din/)**. ### **Therapeutic Claims** These are claims that must be reviewed by the Natural and Non-prescription Health Products Directorate ( **[NNHPD](https://qualitysmartsolutions.com/new-ingredient-submission-nhpid/)**) prior to receiving its market authorization such as **[Drug Identification Number](https://qualitysmartsolutions.com/2-drug-identification-number-din-registration/)** ( **[DIN](https://qualitysmartsolutions.com/2-drug-identification-number-din-registration/)**) or **[Natural Product Number](https://qualitysmartsolutions.com/natural-product-number-npn-license-registration/)** ( **[NPN](https://qualitysmartsolutions.com/natural-product-number-npn-license-registration/)**). These claims can be used in advertising or marketing of the product and must be supported through evidence. Examples are: “Stimulates hair growth”, “Prevent hair loss”, and “Eliminates dandruff”. ## Need help with determining if your product is an NHP, drug or cosmetic? ## Talk to Experts - 1-800-396-5144 ![](https://qualitysmartsolutions.com/wp-content/uploads/2022/01/natural-health-products.webp) **Non-Therapeutic Claims** These are claims that are made on product labels and its advertisements. Though they must be true and accurate, they do not require review and authorization from Health Canada prior to use. Examples are: “Strengthens hair”, “Healthy Hair”, and “Removes loose dandruff flakes”. ### **Classification of your product** In order to classify your product, your product must meet one of the definitions above. Product risk, public health safety, and applicable regulatory framework must also be taken into consideration. Two main factors in determining product classification include representation and composition of the product. ### **Representation and Composition of your product** The classification of your product depends on two main factors: Representation and Composition. Representation can be its function, purpose, and representation for use (such as proposed claims). Composition of your product is the ingredients and their concentrations contained in the formula. For example, in Canada, ingredients like corticosteroids can only be licensed as drugs whereas Green Tea Leaf Extract may be licensed as an **[NHP](https://qualitysmartsolutions.com/nhp-licensing-and-consulting-experts/)** or **[cosmetic product](https://qualitysmartsolutions.com/cosmetics-regulations-compliance-services/)**. However, composition alone may not be sufficient in determining its product classification. ### **Resources:** [https://www.canada.ca/en/health-canada/services/consumer-product-safety/reports-publications/industry-professionals/labelling-cosmetics.html#three2](https://www.canada.ca/en/health-canada/services/consumer-product-safety/reports-publications/industry-professionals/labelling-cosmetics.html#three2) 0/5 (0 Reviews) ##### Related Articles [![FDA proposed rule addressing foreign drug manufacturer and distributed manufacturing registration](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/FDA-Drug-Manufacturing-Registration-300x157.jpg)](https://qualitysmartsolutions.com/news/fda-proposes-rule-to-close-registration-gap-for-foreign-drug-manufacturers/) ### [FDA Proposes Rule to Close Registration Gap for Foreign Drug Manufacturers](https://qualitysmartsolutions.com/news/fda-proposes-rule-to-close-registration-gap-for-foreign-drug-manufacturers/) [![TikTok Shop dietary supplement compliance requirements displayed on a mobile phone screen](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/TikTok-Shop-dietary-supplement-rules-300x157.jpg)](https://qualitysmartsolutions.com/blog/selling-dietary-supplements-on-tiktok-shop-a-compliance-requirements-guide/) ### [Selling Dietary Supplements on TikTok Shop: A Compliance Requirements Guide](https://qualitysmartsolutions.com/blog/selling-dietary-supplements-on-tiktok-shop-a-compliance-requirements-guide/) [![Veterinary health product registration in Canada for pet health companies](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/VHP-registration-in-Canada-300x157.jpg)](https://qualitysmartsolutions.com/blog/vhp-registration-in-canada-what-pet-health-companies-need-to-know/) ### [VHP Registration in Canada: What Pet Health Companies Need to Know](https://qualitysmartsolutions.com/blog/vhp-registration-in-canada-what-pet-health-companies-need-to-know/) [PrevHow Your NHP & Drug Products are Reviewed in Canada CTA v.s NDS](https://qualitysmartsolutions.com/blog/how-drug-products-are-reviewed-in-canada/) [FDA Qualified Health Claim for Magnesium 2022Next](https://qualitysmartsolutions.com/news/fda-announces-qualified-health-claim-for-magnesium-and-reduced-risk-of-high-blood-pressure/) ###### Industries We Serve - [Natural Health Products](https://qualitysmartsolutions.com/nhp-licensing-and-consulting-experts/) - [Medical Devices](https://qualitysmartsolutions.com/medical-device-regulations-mdl-mdel/) - [Dietary Supplements](https://qualitysmartsolutions.com/dietary-supplement-regulation-fda/) - [Cosmetic Products](https://qualitysmartsolutions.com/cosmetics-regulations-compliance-services/) - [Homeopathic Products](https://qualitysmartsolutions.com/homeopathic-products-compliance/) - [Veterinary Health Products](https://qualitysmartsolutions.com/veterinary-health-products-vhp-compliance/) - [OTC Drugs](https://qualitysmartsolutions.com/otc-drug-compliance-din/) - [Canna Solutions](https://qualitysmartsolutions.com/canna-license-solutions/) ###### Related Articles [![TikTok Shop dietary supplement compliance requirements displayed on a mobile phone screen](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/TikTok-Shop-dietary-supplement-rules-300x157.jpg)](https://qualitysmartsolutions.com/blog/selling-dietary-supplements-on-tiktok-shop-a-compliance-requirements-guide/) [Selling Dietary Supplements on TikTok Shop: A Compliance Requirements Guide](https://qualitysmartsolutions.com/blog/selling-dietary-supplements-on-tiktok-shop-a-compliance-requirements-guide/) [![Veterinary health product registration in Canada for pet health companies](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/VHP-registration-in-Canada-300x157.jpg)](https://qualitysmartsolutions.com/blog/vhp-registration-in-canada-what-pet-health-companies-need-to-know/) [VHP Registration in Canada: What Pet Health Companies Need to Know](https://qualitysmartsolutions.com/blog/vhp-registration-in-canada-what-pet-health-companies-need-to-know/) [![FDA mandatory GRAS notification rule document review for food ingredient compliance](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/FDA-GRAS-Notification-300x157.jpg)](https://qualitysmartsolutions.com/news/fda-mandatory-gras-notification-rule-could-reshape-food-ingredient-compliance-by-year-end/) [FDA Mandatory GRAS Notification Rule Could Reshape Food Ingredient Compliance by Year End](https://qualitysmartsolutions.com/news/fda-mandatory-gras-notification-rule-could-reshape-food-ingredient-compliance-by-year-end/) [![Regulatory professional reviewing FSVP compliance documents for selling food products on Amazon USA](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/FSVP-compliance-Amazon-300x157.jpg)](https://qualitysmartsolutions.com/blog/what-amazon-usa-sellers-need-to-know-about-fsvp-compliance/) [What Amazon USA Sellers Need to Know About FSVP Compliance](https://qualitysmartsolutions.com/blog/what-amazon-usa-sellers-need-to-know-about-fsvp-compliance/) [![Health Canada cost-benefit analysis survey on natural health product red tape reduction](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/NHP-red-tape-reduction-survey-300x157.jpg)](https://qualitysmartsolutions.com/news/health-canada-launches-cost-benefit-analysis-survey-on-natural-health-product-red-tape-reduction/) [Health Canada Launches Cost-Benefit Analysis Survey on Natural Health Product Red Tape Reduction](https://qualitysmartsolutions.com/news/health-canada-launches-cost-benefit-analysis-survey-on-natural-health-product-red-tape-reduction/) [![Laser hair removal device undergoing Health Canada compliance review on a clinical table](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/laser-hair-removal-device-300x157.jpg)](https://qualitysmartsolutions.com/blog/laser-hair-removal-device-a-guide-to-health-canada-compliance-requirements/) [Laser Hair Removal Device: A Guide to Health Canada Compliance Requirements](https://qualitysmartsolutions.com/blog/laser-hair-removal-device-a-guide-to-health-canada-compliance-requirements/) ###### Categories - [510k Submissions](https://qualitysmartsolutions.com/topic/medical-device-510k-submissions/) (5) - [Cannabis](https://qualitysmartsolutions.com/topic/cannabis/) (2) - [Cosmetics](https://qualitysmartsolutions.com/topic/cosmetics/) (15) - [Dietary Supplements](https://qualitysmartsolutions.com/topic/dietary-supplements/) (18) - [EFSA](https://qualitysmartsolutions.com/topic/efsa/) (1) - [FDA](https://qualitysmartsolutions.com/topic/fda/) (7) - [Food](https://qualitysmartsolutions.com/topic/food/) (6) - [Food & Beverage](https://qualitysmartsolutions.com/topic/food-beverage/) (20) - [Food Labelling](https://qualitysmartsolutions.com/topic/food-labelling/) (7) - [Food Safety](https://qualitysmartsolutions.com/topic/food-safety/) (22) - [FSMA-FSVP](https://qualitysmartsolutions.com/topic/fsma-fsvp/) (5) - [FSVP Importer](https://qualitysmartsolutions.com/topic/fsvp-importer/) (4) - [GRAS](https://qualitysmartsolutions.com/topic/gras/) (7) - [HACCP](https://qualitysmartsolutions.com/topic/haccp/) (4) - [Health Canada](https://qualitysmartsolutions.com/topic/health-canada/) (11) - [Importer of Record](https://qualitysmartsolutions.com/topic/importer-of-record/) (6) - [Medical Devices](https://qualitysmartsolutions.com/topic/medical-devices/) (43) - [Melatonin](https://qualitysmartsolutions.com/topic/melatonin/) (1) - [Natural Health Products](https://qualitysmartsolutions.com/topic/natural-health-products/) (1) - [Natural Health Products (NHPs)](https://qualitysmartsolutions.com/topic/natural-health-products-nhps/) (39) - [NHP Compliance](https://qualitysmartsolutions.com/topic/nhp-compliance/) (1) - [NPN Application](https://qualitysmartsolutions.com/topic/npn-application/) (4) - [OTC Drugs](https://qualitysmartsolutions.com/topic/otc-drugs/) (13) - [Pediatric Health Products](https://qualitysmartsolutions.com/topic/pediatric-health-products/) (1) - [Prescription Drug List](https://qualitysmartsolutions.com/topic/prescription-drug-list/) (1) - [Regulatory Fees](https://qualitysmartsolutions.com/topic/regulatory-fees/) (1) - [Regulatory Update](https://qualitysmartsolutions.com/topic/regulatory-update/) (1) - [SaMD Software as a Medical Device](https://qualitysmartsolutions.com/topic/samd-software-as-a-medical-device/) (4) - [Veterinary Health Products (VHP)](https://qualitysmartsolutions.com/topic/veterinary-health-products-vhp/) (5) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## FSANZ Novel Food Guidelines [Skip to content](https://qualitysmartsolutions.com/blog/how-fsanz-determines-whether-a-food-is-novel#content) # How FSANZ Determines Whether a Food Is Novel - January 24, 2026 Last updated: April 27, 2026 - Tags:[food compliance](https://qualitysmartsolutions.com/tag/food-compliance/), [fsanz](https://qualitysmartsolutions.com/tag/fsanz/), [novel food](https://qualitysmartsolutions.com/tag/novel-food/), [regulatory approval](https://qualitysmartsolutions.com/tag/regulatory-approval/) - [Blog](https://qualitysmartsolutions.com/blog/), [Regulatory Compliance](https://qualitysmartsolutions.com/blog/regulatory-compliance/) How FSANZ Determines Whether a Food Is Novel - January 24, 2026 - [food compliance](https://qualitysmartsolutions.com/tag/food-compliance/), [fsanz](https://qualitysmartsolutions.com/tag/fsanz/), [novel food](https://qualitysmartsolutions.com/tag/novel-food/), [regulatory approval](https://qualitysmartsolutions.com/tag/regulatory-approval/) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/02/quality-smart-solutions_avatar-96x96.png) [Quality Smart Solutions](https://qualitysmartsolutions.com/blog/how-fsanz-determines-whether-a-food-is-novel#gbio) ## In This Article: ![FSANZ assessment process used to determine whether a food is novel.](https://qualitysmartsolutions.com/wp-content/uploads/2026/01/fsanz-novel-food.jpg) If you are preparing to launch a new ingredient or food product in Australia or New Zealand, one of the first regulatory questions you need to answer is whether the product may be considered novel. This determination has direct implications for compliance, approval timelines, and whether your product can legally enter the market. Many businesses assume that an ingredient already sold in other regions will automatically be accepted locally. However, Food Standards Australia New Zealand applies its own criteria, and products that are familiar elsewhere may still require review. Understanding how FSANZ approaches novelty early can help you avoid delays, reformulation, or enforcement action later on. ## **What FSANZ Means by a Novel Food** FSANZ defines a novel food as a food or ingredient that does not have a significant history of human consumption in Australia or New Zealand. When that history cannot be clearly demonstrated, a pre-market safety assessment is required before the product can be sold. This assessment focuses on local consumption patterns rather than global availability. An ingredient may be widely used overseas and still be considered novel if there is limited evidence that it has been consumed safely in Australia or New Zealand. Processing methods, changes in composition, and intended use are also taken into account. In practical terms, novelty is not about whether a product is innovative or trendy. It is about whether sufficient evidence exists to support its safe consumption in these specific markets. ## **How FSANZ Assesses Novel Food Status** When FSANZ evaluates whether a product falls under novel food requirements, it considers two factors together. The first is whether the food is non-traditional. This generally means there is no established pattern of consumption in Australia or New Zealand. They do not use a fixed calendar date (like the EU’s 15 May 1997) to define novel foods. Instead, they define it based on a “non-traditional” food having no significant history of human consumption in Australia or New Zealand, or requiring a safety assessment due to new technologies or components. The second factor is whether the food requires a safety assessment. Even when some consumption history exists, changes in how the food is produced or used can alter its safety profile. Higher concentrations, new manufacturing processes, or different exposure levels can all trigger regulatory review. Because these factors are assessed on a case-by-case basis, determining whether an ingredient qualifies as a FSANZ novel food often requires a detailed review of available evidence. ## **Foods That Commonly Raise Novelty Questions** Novel food assessments frequently apply to ingredients that fall outside traditional supply chains. This includes certain botanical extracts, alternative protein sources, and foods produced using newer technologies. In some cases, even familiar foods may be considered novel if they are consumed in a new form or at levels that significantly increase dietary exposure. These nuances are easy to overlook, which is why early assessment is critical. Assuming that an ingredient is acceptable without reviewing how FSANZ is likely to interpret its use can create unnecessary regulatory risk. ## **Why Compliance With FSANZ Matters** Compliance with FSANZ novel food requirements is mandatory under the Australia New Zealand Food Standards Code. Foods that are classified as novel cannot be sold unless they have been specifically approved following a safety assessment. Non-compliance can result in enforcement action, product recalls, and delays that affect commercial relationships. Beyond regulatory consequences, failing to meet these requirements can damage credibility with retailers and consumers. Confirming whether your product meets the criteria for a FSANZ novel food before launch helps protect both your investment and your brand. ## **What the FSANZ Approval Process Involves** If a product is determined to be novel, a formal pre-market application must be submitted to FSANZ. This application must demonstrate that the food is safe for its intended use. Submissions typically include information on composition, manufacturing methods, dietary exposure, and toxicological data. FSANZ reviews the evidence and may request additional clarification before making a decision. While the process is clearly defined, applications often face delays when data is incomplete or does not align with FSANZ expectations. Planning ahead and understanding the requirements can make a significant difference. ## **How FSANZ Fits Within a Global Regulatory Strategy** Although FSANZ has its own regulatory framework, its safety principles are consistent with approaches used by other authorities. For example, the U.S. Food and Drug Administration evaluates food safety using scientific evidence and exposure assessments when determining whether an ingredient can be marketed. Reviewing FDA guidance can support a broader compliance strategy, but it does not replace the need to meet FSANZ requirements. For businesses operating across multiple markets, understanding these differences helps avoid assumptions that could slow down approvals. ## **Key Takeaways** - Novel food status is based on local consumption history, not global use - Natural or familiar ingredients may still require assessment - Early review helps avoid delays and compliance issues - Approval is required before novel foods can be sold - Regulatory guidance can reduce uncertainty and risk ## Frequently Asked Questions ### Does being classified as a novel food mean the product is unsafe? No. A novel food classification does not automatically mean a product is unsafe. It simply indicates that FSANZ does not have enough evidence of safe consumption in Australia or New Zealand to make a determination without a formal review. Many ingredients are classified as novel because they are new to the local market, not because they present a known risk. With the right scientific data, many novel foods are approved and sold legally. ### Can I sell or import my product while FSANZ is reviewing my application? No. If your ingredient requires approval, it cannot be sold, imported, or supplied for retail sale until FSANZ has completed its assessment and the ingredient is permitted under the Food Standards Code. Launching early can lead to enforcement action, recalls, and issues with retailers or distributors. ### How long does it usually take to obtain FSANZ approval for a novel food? There is no fixed timeline (minimum 9-15 months). The review period depends on the complexity of the ingredient, how it will be used in food, and whether the submitted data clearly addresses safety concerns. Applications may take longer if FSANZ requests additional information or clarification. Starting the assessment early, ideally during product development, helps avoid unexpected delays close to launch. ### If my ingredient is approved in other countries, do I still need FSANZ approval? Often, yes. FSANZ focuses on consumption history and exposure in Australia and New Zealand. While approvals from other regulators can strengthen your safety case and support your submission, they do not replace FSANZ requirements. Each application is assessed based on local use conditions and dietary exposure. ### What are the risks of assuming my product is not novel? If a product is later determined to meet the criteria for a novel food, it may need to be withdrawn from the market until approval is granted. This can result in lost sales, product recalls, contractual issues with partners, and reputational damage. A proper assessment upfront provides clarity and reduces regulatory and commercial risk. ## Support With Novel Food Assessments Determining whether your ingredient qualifies as a [FSANZ novel food](https://qualitysmartsolutions.com/services/fsanz-novel-food/) and preparing the necessary documentation can be complex, particularly when timelines and investment decisions are involved. Working with regulatory specialists can help you assess risk early and plan a compliant path to market. If you need support reviewing your product or preparing a submission, [our team can help you navigate FSANZ requirements](https://qualitysmartsolutions.com/contact/) and move forward with confidence. 0/5 (0 Reviews) ##### Related Articles [![FDA proposed rule addressing foreign drug manufacturer and distributed manufacturing registration](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/FDA-Drug-Manufacturing-Registration-300x157.jpg)](https://qualitysmartsolutions.com/news/fda-proposes-rule-to-close-registration-gap-for-foreign-drug-manufacturers/) ### [FDA Proposes Rule to Close Registration Gap for Foreign Drug Manufacturers](https://qualitysmartsolutions.com/news/fda-proposes-rule-to-close-registration-gap-for-foreign-drug-manufacturers/) [![TikTok Shop dietary supplement compliance requirements displayed on a mobile phone screen](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/TikTok-Shop-dietary-supplement-rules-300x157.jpg)](https://qualitysmartsolutions.com/blog/selling-dietary-supplements-on-tiktok-shop-a-compliance-requirements-guide/) ### [Selling Dietary Supplements on TikTok Shop: A Compliance Requirements Guide](https://qualitysmartsolutions.com/blog/selling-dietary-supplements-on-tiktok-shop-a-compliance-requirements-guide/) [![Veterinary health product registration in Canada for pet health companies](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/VHP-registration-in-Canada-300x157.jpg)](https://qualitysmartsolutions.com/blog/vhp-registration-in-canada-what-pet-health-companies-need-to-know/) ### [VHP Registration in Canada: What Pet Health Companies Need to Know](https://qualitysmartsolutions.com/blog/vhp-registration-in-canada-what-pet-health-companies-need-to-know/) [PrevWhat to Know Before Submitting a GRAS Notice to the FDA](https://qualitysmartsolutions.com/blog/what-to-know-before-submitting-a-gras-notice-to-the-fda/) [FDA Releases Human Food Program 2026 Priorities For Food BusinessesNext](https://qualitysmartsolutions.com/news/fda-releases-human-food-program-2026-priorities-for-food-businesses/) ###### Industries We Serve - 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[Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Health Canada Regulatory Changes [Skip to content](https://qualitysmartsolutions.com/blog/health-canadas-regulatory-plan-2024-26-proposed-amendments-to-nhp-and-non-prescription-drugs#content) # Health Canada’s Regulatory Plan 2024-26: Proposed Amendments to NHP and Non-Prescription Drugs - July 6, 2024 Last updated: July 14, 2024 - Written by - [Andrew Parshad](https://www.linkedin.com/in/andrewparshad/) - [Blog](https://qualitysmartsolutions.com/blog/) Health Canada’s Regulatory Plan 2024-26: Proposed Amendments to NHP and Non-Prescription Drugs - July 6, 2024 ![](https://qualitysmartsolutions.com/wp-content/uploads/2024/02/andrew-parshad_avatar-96x96.jpg) [Andrew Parshad](https://qualitysmartsolutions.com/blog/health-canadas-regulatory-plan-2024-26-proposed-amendments-to-nhp-and-non-prescription-drugs#gbio) President & Founder of Quality Smart Solutions ## In This Article: ![](https://qualitysmartsolutions.com/wp-content/uploads/2024/07/nhp-blog-300x200.jpg)Health Canada has unveiled its Forward Regulatory Plan for 2024-2026, outlining significant amendments to the Natural Health Products Regulations and the Food and Drug Regulations under the Food and Drugs Act. These amendments are designed to align the regulatory approach for self-care products, ensuring a streamlined and risk-based framework that reflects contemporary standards. To better understand the proposed amendment, it’s essential to first understand Natural Health Products (NHPs) and Non-Prescription Drugs. ##### **What is NHP?** Natural Health Products (NHPs) are a category of health products regulated by Health Canada. These products include a variety of items that support health and wellness through natural means. The category of health products include: - Essential nutrients that support overall health and wellness. - Herbal remedies or plant-based products used for their medicinal properties. - Products based on homeopathy, a system of alternative medicine. - Medicines used traditionally, such as those from traditional Chinese medicine or Ayurvedic medicine. [Click to learn how you can get an NHP Licence for Nicotine Pouches in Canada?](https://qualitysmartsolutions.com/blog/how-to-get-an-nhp-licence-for-nicotine-pouches-in-canada/) ##### **What is non-prescription drug?** Non-Prescription Drugs are medications that can be purchased without a prescription from a healthcare professional. These drugs are also known as Over-the-Counter Drugs or OTC drugs. These drugs are made to treat common, self-diagnosed conditions and symptoms such as pain, fever, coughs, colds, and allergies. Examples of OTC drugs are Pain Relievers and Fever Reducers, Cough and Cold Remedies, Allergy Medications and Antacids and Acid Reducers. [Click this link to learn more about non-prescription drugs](https://qualitysmartsolutions.com/otc-drug-compliance-din-canada/), how you can sell it in Canada, and more facts about it. Now, let’s explore Health Canada’s Forward Regulatory Plan 2024-26 and outline significant amendments to the Natural Health Products Regulations and the Food and Drug Regulations under the Food and Drugs Act. ##### **Health Canada forward regulatory plan: key changes proposed** 1. **Simplified Pathways and Alignment:** Health Canada proposes a new system to fast-track approval for lower-risk non-prescription drugs. This system will align these OTC drugs with natural health products that have similar uses. The goal is to streamline the process while still ensuring that safety standards remain high. 2. **Modernization of Natural Health Products Regulations:** The amendments also target the Natural Health Products Regulations, introducing a structured risk-based categorization system and enhanced quality oversight measures. ##### **Key proposals include:** - **Annual Notification Requirement:** Businesses will be required to annually notify Health Canada of marketed natural health products, enhancing transparency and regulatory oversight. - **Good Manufacturing Practices (GMP):** Strengthening requirements for GMP will ensure that natural health products meet high standards of quality throughout the manufacturing process. - **Risk-Based Site Licensing:** Introducing a risk-based site licensing program will enhance oversight of production facilities, further safeguarding product quality and consistency. These amendments are in response to recommendations from the Commissioner of the Environment and Sustainable Development’s 2021 audit, underscoring Health Canada’s commitment to addressing regulatory gaps and enhancing consumer confidence in natural health products. ##### **International alignment and impact** While these changes aren’t part of a formal international cooperation plan, they will bring Canada’s regulations closer to those of the U.S., EU, and Australia. This alignment should make it easier for Canadian businesses to compete globally and ensure imported products meet Canadian standards. ##### **What it means for businesses and consumers** The proposed amendments are expected to impact businesses involved in the sale and manufacture of natural health products and non-prescription drugs in Canada. - For natural health products, the amendments promise strengthened oversight and improved assurance of product quality, aligning with global best practices. - Meanwhile, amendments to the Food and Drug Regulations aim to maintain robust regulatory oversight while reducing administrative burdens and enhancing operational efficiencies for businesses. ##### **Consultations and stakeholder engagement** Health Canada has engaged stakeholders extensively since 2016 and will continue to do so throughout 2024. The recent publication of regulatory amendments in the Canada Gazette, Part II on July 6, 2022, marked a significant milestone in this ongoing consultation process. These consultations are crucial for gathering feedback from industry stakeholders, healthcare professionals, and the public to ensure that the regulatory framework remains responsive and effective. ##### **Get assisted by Quality Smart Solutions** For detailed insights into these regulatory changes and ongoing consultations, reach out to our team of former Health Canada experts at Quality Smart Solutions. We help ensure compliance with modernized regulations governing [natural health products](https://qualitysmartsolutions.com/nhp-licensing-and-consulting-experts/) (NHPs) and non-prescription drugs, enhancing safety and quality standards across Canada while facilitating business growth and innovation. 0/5 (0 Reviews) ![Picture of Andrew Parshad](https://qualitysmartsolutions.com/wp-content/uploads/2024/02/andrew-parshad_avatar-300x300.jpg) Andrew Parshad Andrew Parshad is President, CEO and founder of Quality Smart Solutions, a North American compliance solutions provider offering regulatory and quality assurance services to comply with FDA & Health Canada brands and ingredients regulations in the categories of dietary supplements, foods, cosmetics, OTC drugs and medical devices. Andrew started Quality Smart Solutions in 2007. Since that time he and his firm has served thousands of clients worldwide . Andrew's affiliate company, Quality IMPORT Solutions that offers import agent services into the Canadian market as a government licensed importer for foods, dietary supplements and medical devices. ##### Related Articles [![FDA proposed rule addressing foreign drug manufacturer and distributed manufacturing registration](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/FDA-Drug-Manufacturing-Registration-300x157.jpg)](https://qualitysmartsolutions.com/news/fda-proposes-rule-to-close-registration-gap-for-foreign-drug-manufacturers/) ### [FDA Proposes Rule to Close Registration Gap for Foreign Drug Manufacturers](https://qualitysmartsolutions.com/news/fda-proposes-rule-to-close-registration-gap-for-foreign-drug-manufacturers/) [![TikTok Shop dietary supplement compliance requirements displayed on a mobile phone screen](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/TikTok-Shop-dietary-supplement-rules-300x157.jpg)](https://qualitysmartsolutions.com/blog/selling-dietary-supplements-on-tiktok-shop-a-compliance-requirements-guide/) ### [Selling Dietary Supplements on TikTok Shop: A Compliance Requirements Guide](https://qualitysmartsolutions.com/blog/selling-dietary-supplements-on-tiktok-shop-a-compliance-requirements-guide/) [![Veterinary health product registration in Canada for pet health companies](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/VHP-registration-in-Canada-300x157.jpg)](https://qualitysmartsolutions.com/blog/vhp-registration-in-canada-what-pet-health-companies-need-to-know/) ### [VHP Registration in Canada: What Pet Health Companies Need to Know](https://qualitysmartsolutions.com/blog/vhp-registration-in-canada-what-pet-health-companies-need-to-know/) [PrevHealth Canada 2024 Drug Establishment Licensing (DEL) Update](https://qualitysmartsolutions.com/blog/health-canada-2024-drug-establishment-licensing-del-update/) [FDA MoCRA Compliance Guide for Cosmetic BusinessesNext](https://qualitysmartsolutions.com/blog/fda-mocra-compliance-guide-for-cosmetic-businesses/) ###### Industries We Serve - [Natural Health Products](https://qualitysmartsolutions.com/nhp-licensing-and-consulting-experts/) - [Medical Devices](https://qualitysmartsolutions.com/medical-device-regulations-mdl-mdel/) - [Dietary Supplements](https://qualitysmartsolutions.com/dietary-supplement-regulation-fda/) - [Cosmetic Products](https://qualitysmartsolutions.com/cosmetics-regulations-compliance-services/) - [Homeopathic Products](https://qualitysmartsolutions.com/homeopathic-products-compliance/) - [Veterinary Health Products](https://qualitysmartsolutions.com/veterinary-health-products-vhp-compliance/) - [OTC Drugs](https://qualitysmartsolutions.com/otc-drug-compliance-din/) - [Canna Solutions](https://qualitysmartsolutions.com/canna-license-solutions/) ###### Related Articles [![TikTok Shop dietary supplement compliance requirements displayed on a mobile phone screen](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/TikTok-Shop-dietary-supplement-rules-300x157.jpg)](https://qualitysmartsolutions.com/blog/selling-dietary-supplements-on-tiktok-shop-a-compliance-requirements-guide/) [Selling Dietary Supplements on TikTok Shop: A Compliance Requirements Guide](https://qualitysmartsolutions.com/blog/selling-dietary-supplements-on-tiktok-shop-a-compliance-requirements-guide/) [![Veterinary health product registration in Canada for pet health companies](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/VHP-registration-in-Canada-300x157.jpg)](https://qualitysmartsolutions.com/blog/vhp-registration-in-canada-what-pet-health-companies-need-to-know/) [VHP Registration in Canada: What Pet Health Companies Need to Know](https://qualitysmartsolutions.com/blog/vhp-registration-in-canada-what-pet-health-companies-need-to-know/) [![FDA mandatory GRAS notification rule document review for food ingredient compliance](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/FDA-GRAS-Notification-300x157.jpg)](https://qualitysmartsolutions.com/news/fda-mandatory-gras-notification-rule-could-reshape-food-ingredient-compliance-by-year-end/) [FDA Mandatory GRAS Notification Rule Could Reshape Food Ingredient Compliance by Year End](https://qualitysmartsolutions.com/news/fda-mandatory-gras-notification-rule-could-reshape-food-ingredient-compliance-by-year-end/) [![Regulatory professional reviewing FSVP compliance documents for selling food products on Amazon USA](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/FSVP-compliance-Amazon-300x157.jpg)](https://qualitysmartsolutions.com/blog/what-amazon-usa-sellers-need-to-know-about-fsvp-compliance/) [What Amazon USA Sellers Need to Know About FSVP Compliance](https://qualitysmartsolutions.com/blog/what-amazon-usa-sellers-need-to-know-about-fsvp-compliance/) [![Health Canada cost-benefit analysis survey on natural health product red tape reduction](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/NHP-red-tape-reduction-survey-300x157.jpg)](https://qualitysmartsolutions.com/news/health-canada-launches-cost-benefit-analysis-survey-on-natural-health-product-red-tape-reduction/) [Health Canada Launches Cost-Benefit Analysis Survey on Natural Health Product Red Tape Reduction](https://qualitysmartsolutions.com/news/health-canada-launches-cost-benefit-analysis-survey-on-natural-health-product-red-tape-reduction/) [![Laser hair removal device undergoing Health Canada compliance review on a clinical table](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/laser-hair-removal-device-300x157.jpg)](https://qualitysmartsolutions.com/blog/laser-hair-removal-device-a-guide-to-health-canada-compliance-requirements/) [Laser Hair Removal Device: A Guide to Health Canada Compliance Requirements](https://qualitysmartsolutions.com/blog/laser-hair-removal-device-a-guide-to-health-canada-compliance-requirements/) ###### Categories - [510k Submissions](https://qualitysmartsolutions.com/topic/medical-device-510k-submissions/) (5) - [Cannabis](https://qualitysmartsolutions.com/topic/cannabis/) (2) - [Cosmetics](https://qualitysmartsolutions.com/topic/cosmetics/) (15) - [Dietary Supplements](https://qualitysmartsolutions.com/topic/dietary-supplements/) (18) - [EFSA](https://qualitysmartsolutions.com/topic/efsa/) (1) - [FDA](https://qualitysmartsolutions.com/topic/fda/) (7) - [Food](https://qualitysmartsolutions.com/topic/food/) (6) - [Food & Beverage](https://qualitysmartsolutions.com/topic/food-beverage/) (20) - [Food Labelling](https://qualitysmartsolutions.com/topic/food-labelling/) (7) - [Food Safety](https://qualitysmartsolutions.com/topic/food-safety/) (22) - [FSMA-FSVP](https://qualitysmartsolutions.com/topic/fsma-fsvp/) (5) - [FSVP Importer](https://qualitysmartsolutions.com/topic/fsvp-importer/) (4) - [GRAS](https://qualitysmartsolutions.com/topic/gras/) (7) - [HACCP](https://qualitysmartsolutions.com/topic/haccp/) (4) - 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[Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## GRAS and NDI Explained [Skip to content](https://qualitysmartsolutions.com/blog/gras-generally-recognized-as-safe-new-dietary-ingredient-ndin#content) # GRAS Consultants: NDIN or FDA GRAS Certification? - October 28, 2022 Last updated: June 9, 2025 - Tags:[Dietary Supplements](https://qualitysmartsolutions.com/tag/dietary-supplements/), [FDA](https://qualitysmartsolutions.com/tag/fda/), [Food Products](https://qualitysmartsolutions.com/tag/food-products/), [GRAS](https://qualitysmartsolutions.com/tag/gras/), [NDI](https://qualitysmartsolutions.com/tag/ndi/) - [Blog](https://qualitysmartsolutions.com/blog/) GRAS Consultants: NDIN or FDA GRAS Certification? - October 28, 2022 - [Dietary Supplements](https://qualitysmartsolutions.com/topic/dietary-supplements/) - [Dietary Supplements](https://qualitysmartsolutions.com/tag/dietary-supplements/), [FDA](https://qualitysmartsolutions.com/tag/fda/), [Food Products](https://qualitysmartsolutions.com/tag/food-products/), [GRAS](https://qualitysmartsolutions.com/tag/gras/), [NDI](https://qualitysmartsolutions.com/tag/ndi/) ![](https://qualitysmartsolutions.com/wp-content/cache/flying-press/gravatar-3b2d33a046a3.png) [Alessandra Marimon](https://qualitysmartsolutions.com/blog/gras-generally-recognized-as-safe-new-dietary-ingredient-ndin#gbio) ## In This Article: ![](https://qualitysmartsolutions.com/wp-content/uploads/2021/09/tabs-1.jpg)Say you have a new ingredient and are ready to enter the US food market. To ensure this ingredient is considered approved (and the product will not be considered adulterated upon formulation) for use, you have a decision to make: Do you wish to obtain ingredient approval through GRAS (Generally Recognized As Safe) or via NDI ( **[New Dietary Ingredient](https://qualitysmartsolutions.com/new-dietary-ingredient-notification-ndin/)**)? **An Overview of ‘GRAS’ – General Recognized As Safe:** Wondering what GRAS stands for? Learn all about this FDA approval process and its implications for food & beverage products. GRAS stands for Generally Recognized As Safe, the designation from the U.S. Food and Drug Administration that applies to ingredients used in food and beverage production. It indicates that an ingredient has been determined safe for its intended use and does not require pre-market approval. This blog will explore the concepts and requirements surrounding both **[GRAS](https://qualitysmartsolutions.com/fda-gras-ndi-experts/)** and NDI to help you navigate your ingredients into the US food supply. We will discuss each pathway and reasons why your company may want to favour one over the other. **What is GRAS?** GRAS is a designation from the U.S. Food and Drug Administration (FDA) that applies to ingredients used in food and beverage production. This official designation indicates an ingredient has been determined safe for its intended use and does not require pre-market approval from the FDA. Generally, this means that if an independent panel of experts has deemed a food component or additive as safe to consume, then it is considered “generally recognized as safe” or “GRAS”. **How Does the GRAS Process Work?** The GRAS process consists of two different ways an ingredient can be approved as safe for use in food and beverages. First, a manufacturer can convene their own panel to review data from their research and determine if that specific ingredient is safe for its intended use. Alternatively, the FDA has established a list of recognized substances considered safe for use in different products without further testing. When those two processes have been completed, then the ingredient can be designated as GRAS or generally recognized as safe. **Who Gets to Decide Which Ingredients Receive GRAS Status?** The FDA has the final say on which ingredients and additives are designated as GRAS, but that authority may be delegated to certain expert panels or scientific bodies. When a manufacturer completes their own research and determines an ingredient is safe for use, it does not automatically receive GRAS status from the FDA until it has been thoroughly reviewed and approved according to existing criteria. This process allows for special consideration of ingredients believed to be safe that do not necessarily fit into pre-defined categories. **What Are the Benefits of GRAS Certification?** Having GRAS certification carries several benefits. It indicates that a product has met stringent FDA-approved criteria for safety, which makes it easier for manufacturers to get their products onto the market quickly and comply with regulatory requirements. Additionally, GRAS-certified ingredients tend to have higher prices due to their increased safety assurance and shorter waiting period before they can be used in food/beverage production. This can benefit manufacturers as well as retailers who need fewer delays in sourcing ingredients for their products. **What Risks are Associated with GRAS Certification?** Obtaining GRAS certification can be a long and tough process, and it can take months—or even years—to obtain. This is due to the fact that not all ingredients are immediately granted this status by the FDA, but must go through additional testing and review to prove they meet the requirements. Furthermore, there have been some issues in the past with products claiming GRAS status without going through all of these steps, which can lead to health issues if these products are not monitored prior to their release and ingestion by consumers. **What Does Generally Recognized as Safe (GRAS) stand for?** GRAS stands for “Generally Recognized As Safe”. GRAS is the more flexible option as these decisions allow use in foods and dietary supplements no additional processing is applied to the ingredient. **How Do I Classify my Ingredient as GRAS?** Ingredients can be self-affirmed GRAS or submitted via notification to the FDA for approval. **Self-Affirmed** **GRAS** _–_ The ingredient must be widely used in the food supply to meet the self-affirmed criteria. GRAS assessments require the substantiation/evidence to be made available to the public upon approval, thus limiting discretion. The requirement for proof is use in conventional foods for a long period of time and/or the food is considered safe by experts. Essentially you need to prove safe historical use. **GRAS Notification to the FDA** – FDA reserves the right to take 180 days or longer to evaluate a GRAS notification. Once an ingredient is approved via the GRAS route, it can be used in both food and dietary supplements. GRAS ingredients must meet the safety standard: _reasonable certainty of no harm under the intended use conditions._ GRAS ingredients must meet the lower GMP standards set out in 21 CFR 110. To summarize, this notification process takes longer to obtain but allows for use of the ingredient in food and dietary supplements. **What Does New Dietary Ingredient (NDI) Stand For?** NDI stands for “New Dietary Ingredient”. Unless considered an ‘old dietary ingredient’ (used in dietary supplement products prior to October 15, 1994), an NDIN ( [**New Dietary Ingredient Notification**](https://qualitysmartsolutions.com/new-dietary-ingredient-notification-ndin/)) must be sent to and approved by the FDA. NDI approved ingredients are only approved for use within Dietary Supplements, thus limiting applications and uses of your ingredient. The NDI notification process will keep your submitted documentation largely between you and the regulator and is a good option for proprietary research/documentation. The NDI review standard is within 75 days, a considerably shorter timeline. NDI ingredients must meet the safety standard: _does not present a significant or unreasonable risk of illness or injury_. NDI ingredients must meet the higher GMP standards set out in 21 CFR 111. To summarize, this notification process is shorter in overall length, but only allows your ingredient to be used in dietary supplements. **Summary** In conclusion, although the GRAS notification process takes longer on average it allows the most flexibility for end use (ie. use in dietary supplements and in food). NDI allows you to keep your documentation private, has a shorter review period but only allows you to market your ingredient within **[Dietary Supplements](https://qualitysmartsolutions.com/dietary-supplement-regulation-fda/)**. There are pros and cons to each. Ultimately, how you wish to position your finished goods is the best deciding factor to choose **[GRAS](https://qualitysmartsolutions.com/fda-gras-ndi-experts/)** or NDIN. The self-affirmed pathway allows for the quickest pathway to market, but you are still required to have significant evidence/proof. **Additional Reading about GRAS:** - Gras Certification in the Food Industry - [Benefits of a Self-Affirmed GRAS Dossier for your business](https://qualitysmartsolutions.com/blog/benefits-of-a-self-affirmed-gras-dossier-for-your-business/) - [Navigating the GRAS Process for food manufacturers](https://qualitysmartsolutions.com/blog/navigating-the-gras-process-a-guide-for-food-manufacturers/) - [FDA GRAS Status](https://qualitysmartsolutions.com/blog/everything-you-should-know-about-fda-gras-status-in-2023/) - [GRAS List for Food Additives food safety](https://qualitysmartsolutions.com/blog/gras-list-for-food-additives-your-guide-to-safety/) - [Everything to know about GRAS Ingredients](https://qualitysmartsolutions.com/blog/everything-you-should-know-about-gras-ingredients/) - [Generally Recognized as Safe GRAS Guide](https://qualitysmartsolutions.com/blog/what-is-classified-as-generally-regarded-as-safe-fda/) - FDA GRAS Notice & GRAS Database - [GRAS, NDI, ODI Food Additives Unlocked](https://qualitysmartsolutions.com/blog/gras-ndi-odi-food-additives-food-classification/) Please contact our team for more information on [food classification](https://qualitysmartsolutions.com/food-beverage-regulatory-compliance-canada/), ingredient feasibility questions, ingredient submissions, and food labelling projects. Our specialists are here to help with the following services; [Novel Food Notifications](https://qualitysmartsolutions.com/novel-food-notification/), [SFCR License application](https://qualitysmartsolutions.com/safe-food-for-canadians-regulations-sfcr-license/), [HACCP & PCP](https://qualitysmartsolutions.com/haccp-and-preventive-control-plan-pcp-setup/) program, [TMA License for Supplemented Foods](https://qualitysmartsolutions.com/tma-license-for-supplemented-foods/), [Nutrition Facts Table (NFT) Creation](https://qualitysmartsolutions.com/nutrition-facts-table-nft-creation/) and [label compliance!](https://qualitysmartsolutions.com/food-label-compliance-and-french-translation/) 0/5 (0 Reviews) ##### Related Articles [![FDA proposed rule addressing foreign drug manufacturer and distributed manufacturing registration](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/FDA-Drug-Manufacturing-Registration-300x157.jpg)](https://qualitysmartsolutions.com/news/fda-proposes-rule-to-close-registration-gap-for-foreign-drug-manufacturers/) ### [FDA Proposes Rule to Close Registration Gap for Foreign Drug Manufacturers](https://qualitysmartsolutions.com/news/fda-proposes-rule-to-close-registration-gap-for-foreign-drug-manufacturers/) [![TikTok Shop dietary supplement compliance requirements displayed on a mobile phone screen](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/TikTok-Shop-dietary-supplement-rules-300x157.jpg)](https://qualitysmartsolutions.com/blog/selling-dietary-supplements-on-tiktok-shop-a-compliance-requirements-guide/) ### [Selling Dietary Supplements on TikTok Shop: A Compliance Requirements Guide](https://qualitysmartsolutions.com/blog/selling-dietary-supplements-on-tiktok-shop-a-compliance-requirements-guide/) [![Veterinary health product registration in Canada for pet health companies](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/VHP-registration-in-Canada-300x157.jpg)](https://qualitysmartsolutions.com/blog/vhp-registration-in-canada-what-pet-health-companies-need-to-know/) ### [VHP Registration in Canada: What Pet Health Companies Need to Know](https://qualitysmartsolutions.com/blog/vhp-registration-in-canada-what-pet-health-companies-need-to-know/) [PrevKey Natural Health Product Regulations Canadian Businesses Should Know](https://qualitysmartsolutions.com/blog/top-natural-health-product-regulations-in-canada/) [Inside Scoop FDA Medical Device User Fees (MDUFA) for 2023Next](https://qualitysmartsolutions.com/news/fda-inside-scoop-medical-device-user-fees-mdufa-for-2023/) ###### Industries We Serve - [Natural Health Products](https://qualitysmartsolutions.com/nhp-licensing-and-consulting-experts/) - [Medical Devices](https://qualitysmartsolutions.com/medical-device-regulations-mdl-mdel/) - [Dietary Supplements](https://qualitysmartsolutions.com/dietary-supplement-regulation-fda/) - [Cosmetic Products](https://qualitysmartsolutions.com/cosmetics-regulations-compliance-services/) - [Homeopathic Products](https://qualitysmartsolutions.com/homeopathic-products-compliance/) - [Veterinary Health Products](https://qualitysmartsolutions.com/veterinary-health-products-vhp-compliance/) - [OTC Drugs](https://qualitysmartsolutions.com/otc-drug-compliance-din/) - [Canna Solutions](https://qualitysmartsolutions.com/canna-license-solutions/) ###### Related Articles [![TikTok Shop dietary supplement compliance requirements displayed on a mobile phone screen](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/TikTok-Shop-dietary-supplement-rules-300x157.jpg)](https://qualitysmartsolutions.com/blog/selling-dietary-supplements-on-tiktok-shop-a-compliance-requirements-guide/) [Selling Dietary Supplements on TikTok Shop: A Compliance Requirements Guide](https://qualitysmartsolutions.com/blog/selling-dietary-supplements-on-tiktok-shop-a-compliance-requirements-guide/) [![Veterinary health product registration in Canada for pet health companies](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/VHP-registration-in-Canada-300x157.jpg)](https://qualitysmartsolutions.com/blog/vhp-registration-in-canada-what-pet-health-companies-need-to-know/) [VHP Registration in Canada: What Pet Health Companies Need to Know](https://qualitysmartsolutions.com/blog/vhp-registration-in-canada-what-pet-health-companies-need-to-know/) [![FDA mandatory GRAS notification rule document review for food ingredient compliance](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/FDA-GRAS-Notification-300x157.jpg)](https://qualitysmartsolutions.com/news/fda-mandatory-gras-notification-rule-could-reshape-food-ingredient-compliance-by-year-end/) [FDA Mandatory GRAS Notification Rule Could Reshape Food Ingredient Compliance by Year End](https://qualitysmartsolutions.com/news/fda-mandatory-gras-notification-rule-could-reshape-food-ingredient-compliance-by-year-end/) [![Regulatory professional reviewing FSVP compliance documents for selling food products on Amazon USA](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/FSVP-compliance-Amazon-300x157.jpg)](https://qualitysmartsolutions.com/blog/what-amazon-usa-sellers-need-to-know-about-fsvp-compliance/) [What Amazon USA Sellers Need to Know About FSVP Compliance](https://qualitysmartsolutions.com/blog/what-amazon-usa-sellers-need-to-know-about-fsvp-compliance/) [![Health Canada cost-benefit analysis survey on natural health product red tape reduction](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/NHP-red-tape-reduction-survey-300x157.jpg)](https://qualitysmartsolutions.com/news/health-canada-launches-cost-benefit-analysis-survey-on-natural-health-product-red-tape-reduction/) [Health Canada Launches Cost-Benefit Analysis Survey on Natural Health Product Red Tape Reduction](https://qualitysmartsolutions.com/news/health-canada-launches-cost-benefit-analysis-survey-on-natural-health-product-red-tape-reduction/) [![Laser hair removal device undergoing Health Canada compliance review on a clinical table](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/laser-hair-removal-device-300x157.jpg)](https://qualitysmartsolutions.com/blog/laser-hair-removal-device-a-guide-to-health-canada-compliance-requirements/) [Laser Hair Removal Device: A Guide to Health Canada Compliance Requirements](https://qualitysmartsolutions.com/blog/laser-hair-removal-device-a-guide-to-health-canada-compliance-requirements/) ###### Categories - 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By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Food Label Translation Services [Skip to content](https://qualitysmartsolutions.com/services/canada-food-label-french-translation#content) # Food Label Compliance and French Translation We help you develop compliant labels and provide French translation services. Let us be your partner to create graphic labels ready-for-print, review labels for compliance and ensure your labels meet all new Health Canada food regulations. Food labeling regulations in Canada are designed to provide consumers with clear and accurate product information. From ingredient lists to nutrition facts, understanding the basics of food labeling will help you make informed decisions about what you eat. [Free Consultation](https://qualitysmartsolutions.com/services/canada-food-label-french-translation#enqy_form_sub) ## Requirements for a Food Label In Canada Health Canada and the **[Canadian Food Inspection Agency](https://qualitysmartsolutions.com/news/cfia-and-health-canada-joint-policy-statement-on-food-labelling-coordination/)** ( **[CFIA](https://qualitysmartsolutions.com/news/cfia-and-health-canada-joint-policy-statement-on-food-labelling-coordination/)**) govern Canada’s **[food label regulations](https://qualitysmartsolutions.com/food-label-compliance-and-french-translation/)**. Label requirements include country of origin, units of measure (where applicable), bilingual nutrition facts table, allergen statements. Depending on your nutrient profile as per the **[Nutrition Facts](https://qualitysmartsolutions.com/nutrition-facts-table-nft-creation/)** Table there may be an opportunity to qualify nutrient claims (eg. low in saturated fat, high in protein, etc.) In 2026, the Front of Package (FOP) regulations come into effect requiring a symbol to be placed on food labels that meet the criteria containing high sodium, carbohydrates and/or fat. ## Core Labelling Requirements | Bilingual Labelling | List of Ingredients and Allergens | | --- | --- | | Common Name | Net Quantity | | Country of Origin | Nutrition Labelling | | Date Markings and Storage Instructions | Sweeteners | | Name and Principal Place of Business | Food Additives | | Irradiated Foods | Fortification | | Legibility and Location | Grades | | | Standards of Identity | ## French Translation for Nutrition Facts Table According to **[Health Canada](https://qualitysmartsolutions.com/news/cfia-and-health-canada-joint-policy-statement-on-food-labelling-coordination/)**, every piece of important information on consumer prepackaged food must be available in both languages, i.e., French and English. Such information includes core labelling requirements, like common name, and prescribed words or expressions for specific foods. ![bilingual labelling requirements in canada](https://qualitysmartsolutions.com/wp-content/uploads/2021/03/nutrition_tbl.jpg) ![bilingual nutrition facts](https://qualitysmartsolutions.com/wp-content/uploads/2021/03/food_nutri.jpg) ## Health Canada Food Label Compliance Solutions Our **[compliance experts](https://qualitysmartsolutions.com/food-beverage-regulatory-compliance/)** help you review labels for different types of foods like canned goods, beverages, cereals, dry products, **[meats](https://qualitysmartsolutions.com/meat-or-seafood-permit/)** and others. Besides, we provide **[French label translation](https://qualitysmartsolutions.com/food-label-compliance-and-french-translation/)** services to meet Canadian legal and regulatory labelling requirements. We offer fast, affordable, packaging compliance solutions. ## What is the basic Information needed on Food Labels in Canada? Canadian food labels are legally required to have basic information about the product, such as its name, ingredients list, nutritional facts table, and allergen warnings. Also listed on most food labels are the lot number, expiration date or best before date, weight or volume of the product, country of origin, and contact information for the manufacturer. All this information must be written in both English and French so that bilingual consumers can easily understand it. ![Food Label Requirements in Canada French Compliance](https://qualitysmartsolutions.com/wp-content/uploads/elementor/thumbs/QssCLE-Social-Media-Creatives-Additional-79-rnvfg9asj6v0y85tf6jm0wrui09i2bmms7rqa2h4eg.webp) ![Food Label Requirements in Canada French Compliance](https://qualitysmartsolutions.com/wp-content/uploads/elementor/thumbs/QssCLE-Social-Media-Creatives-Additional-81-rnvfgpa1rdgwfliltvg9paqolk2qp6e2ieuzfrtfgo.webp) ## What are the Nutrition Facts Table and Serving Size Requirements? Canadian food labels are legally required to have basic information about the product, such as its name, ingredients list, nutritional facts table, and allergen warnings. Also listed on most food labels are the lot number, expiration date or best before date, weight or volume of the product, country of origin, and contact information for the manufacturer. All this information must be written in both English and French so that bilingual consumers can easily understand it. ## How are allergens and Intolerances listed and labeled on food labels in Canada? According to the Canadian Food Inspection Agency, all food labels must list the presence of common allergens, gluten sources, and sulphites in amounts of 10 ppm or more. Listing these substances on a food label can help those who deal with allergies or intolerances make better-informed decisions about the products they choose to buy. Also, items must be labeled in bold font as part of the ingredient list if they contain any of these special food ingredients. ![Food Label Requirements in Canada French Compliance](https://qualitysmartsolutions.com/wp-content/uploads/elementor/thumbs/QssCLE-Social-Media-Creatives-Additional-78-rnvfg2px7cm0oyfdhlp81gfmcb5xkfwifb7bx4qvm0.webp) ![Food Label Requirements in Canada French Compliance](https://qualitysmartsolutions.com/wp-content/uploads/elementor/thumbs/QssCLE-Social-Media-Creatives-Additional-82-rnvfgwsra1r70h7olypa98udcn1oer7x7g2v9zia2w.webp) ## What are the prepackaged food products country of origin labelling requirements? Prepackaged food products must specify the country of origin on their label if they contain ingredients from more than one country. The label should show the name(s) of any countries where an ingredient was grown, produced, packaged, or manufactured. However, a requirement for country of origin labeling does not apply to fruits, vegetables, or certain types of fish. It also does not cover single-ingredient foods such as coffee beans, salt, or baking soda. ## What are the labelling regulations for alcoholic beverages in Canada? All alcoholic beverages sold in Canada must comply with federal and provincial labeling requirements. At a minimum, those labels must include the product name and type, the alcohol content percentage, the net quantity of the container, and the supplier’s name and address. In addition to this information, wine products must also specify the vintner or grape variety used to make the product. Beer products must list their ingredients (including water), as well as any additives used in the product. For spirituous liquors such as vodka or gin, a statement of original proof is required. ![Food Label Requirements in Canada French Compliance](https://qualitysmartsolutions.com/wp-content/uploads/elementor/thumbs/QssCLE-Social-Media-Creatives-Additional-80-rnvfggti1v5bj3uw79smkuvj938frwghh8zm4a5z0o.webp) ## Frequently Asked Questions What are the requirements for a food label in Canada? Health Canada and the [**Canadian Food Inspection Agency**](https://qualitysmartsolutions.com/news/cfia-and-health-canada-joint-policy-statement-on-food-labelling-coordination/) ( [**CFIA**](https://qualitysmartsolutions.com/news/cfia-and-health-canada-joint-policy-statement-on-food-labelling-coordination/)) govern Canada’s [**food label regulations**](https://qualitysmartsolutions.com/food-label-compliance-and-french-translation/). Label requirements include country of origin, units of measure (where applicable), bilingual nutrition facts table, and allergen statements. Depending on your nutrient profile as per the [**Nutrition Facts**](https://qualitysmartsolutions.com/nutrition-facts-table-nft-creation/) Table there may be an opportunity to qualify nutrient claims (e.g. low in saturated fat, high in protein, etc.) What are the bilingual labeling requirements in Canada? All food products must be translated for the following in Canada: 1. Common Name 2. Country of Origin 3. Date Markings and Storage Instructions 4. Name and Principal Place of Business 5. Irradiated Foods 6. Legibility and Location What does Health Canada require food labels to list? 1. Net Quantity 2. Nutrition Labelling 3. Sweeteners 4. Food Additives 5. Fortification 6. Grades 7. Standards of Identity 8. Ingredients & Allergens What French Translation is required for the Nutrition Facts Table? According to [**Health Canada**](https://qualitysmartsolutions.com/news/cfia-and-health-canada-joint-policy-statement-on-food-labelling-coordination/), every piece of important information on consumer prepackaged food must be available in both languages, i.e., French and English. Such information includes core labeling requirements, common names, and prescribed words or expressions. 0/5 (0 Reviews) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Sodium Targets Report [Skip to content](https://qualitysmartsolutions.com/news/health-canada-issues-interim-report-on-sodium-targets-for-processed-food#content) # Health Canada issues interim report on sodium targets for processed food - July 9, 2025 Last updated: July 9, 2025 - Written by - [Andrew Parshad](https://www.linkedin.com/in/andrewparshad/) - Tags:[Compliance](https://qualitysmartsolutions.com/tag/compliance/), [Health Canada](https://qualitysmartsolutions.com/tag/health-canada/), [Processed Foods](https://qualitysmartsolutions.com/tag/processed-foods/), [Reinformulation](https://qualitysmartsolutions.com/tag/reinformulation/), [Sodium](https://qualitysmartsolutions.com/tag/sodium/) - [Food and nutrition compliance](https://qualitysmartsolutions.com/news/food-and-nutrition-compliance/), [News](https://qualitysmartsolutions.com/news/) Health Canada issues interim report on sodium targets for processed food - July 9, 2025 - [Compliance](https://qualitysmartsolutions.com/tag/compliance/), [Health Canada](https://qualitysmartsolutions.com/tag/health-canada/), [Processed Foods](https://qualitysmartsolutions.com/tag/processed-foods/), [Reinformulation](https://qualitysmartsolutions.com/tag/reinformulation/), [Sodium](https://qualitysmartsolutions.com/tag/sodium/) ![](https://qualitysmartsolutions.com/wp-content/uploads/2024/02/andrew-parshad_avatar-96x96.jpg) [Andrew Parshad](https://qualitysmartsolutions.com/news/health-canada-issues-interim-report-on-sodium-targets-for-processed-food#gbio) President & Founder of Quality Smart Solutions ## In This Article: **![Health Canada’s interim report on sodium targets for processed food](https://qualitysmartsolutions.com/wp-content/uploads/2025/07/sodium-reduction-in-processed-foods.jpg)** ## **Introduction** Sodium reduction in processed foods is no longer optional. It is a critical step for industry players to safeguard consumer health and meet Health Canada’s 2025 targets. Too much sodium raises blood pressure and increases the risk of heart disease and stroke, which are among the leading causes of death in Canada. In December 2020, Health Canada introduced voluntary sales-weighted average (SWA) sodium targets for nine processed food categories and continues to measure progress through interim assessments. The latest report sampled 1,283 products between October 2023 and July 2024, revealing that while some categories have made headway, overall progress remains modest. Keep reading to learn more about how your business can align with Health Canada’s targets and improve compliance outcomes. ## **Why sodium reduction matters** High sodium intake contributes to hypertension, affecting roughly one in four Canadian adults and elevating the risk of cardiovascular disease and stroke. Because over 75% of dietary sodium comes from processed and prepared foods, reformulation is key to lowering population-level intake and reducing healthcare costs. By meeting SWA targets, you not only support public health but also demonstrate leadership in responsible manufacturing. ## **Interim results at a glance** The interim assessment shows varied progress across categories. Hearth breads led the way, reaching about 40% of the reduction needed to meet the 2025 SWA target. In contrast, pizza crusts and tomato sauces recorded increases in sodium levels since the 2017 baseline. Below is a summary of progress by category: | | | | --- | --- | | **Food category** | **Progress toward 2025 target (%)** | | Hearth bread | 40.3 | | White bread | 18.5 | | Bread with savoury additions | 15.3 | | Processed cheese products | 15.3 | | Ready-to-serve soups | 6.2 | | Whole wheat and mixed grain bread | -7.6 | | Ready-to-eat cereals | -19.2 | | Tomato sauce | -26.4 | | Pizza crust | -57.6 | ## **Common challenges for industry** Manufacturers often face multiple hurdles when reducing sodium. Salt contributes to flavor, texture, and shelf life, and cutting more than 15 to 20% at once can affect product quality and consumer acceptance. Lower sodium levels also require adjustments in processing to maintain microbial safety, leading some businesses to delay or slow reformulation efforts. ## **Practical steps to meet targets** If your product portfolio still exceeds the SWA or maximum level targets, consider these actions: 1. **Audit your sodium levels**. Compare each SKU’s sodium content per 100 g against the 2025 SWA and maximum level targets. 2. **Prioritize high-volume SKUs**. Focus reformulation efforts on best-selling items to maximize impact on overall averages. 3. **Implement gradual reductions**. Aim for incremental decreases of 5 to 10% at a time to maintain taste and safety while allowing consumer adaptation. 4. **Communicate transparently**. Highlight sodium reductions on packaging and in marketing materials and explain the health benefits to consumers. 5. **Leverage expert support**. Partner with regulatory compliance specialists who can guide formulation changes, testing protocols, and labeling requirements. By following these steps, you position your products to meet Health Canada’s endpoints and gain a competitive edge. ## Frequently asked questions ### What if my products still exceed the 2025 targets? Failing to meet voluntary targets will not trigger immediate penalties. However, slow progress may invite increased scrutiny under the Healthy Eating Strategy and erode consumer trust. Acting now minimizes risk if targets become mandatory in the future. ### Are these targets mandatory? No, current targets remain voluntary. Yet Health Canada’s ongoing monitoring signals a potential move toward enforcement. Companies that adapt early will face fewer surprises. ### Where can I find the full interim assessment? You can review the complete interim assessment, including detailed tables and methodology, by visiting the [Health Canada’s website](https://www.canada.ca/en/health-canada/services/publications/food-nutrition/sodium-reduction-select-processed-foods-interim-assessment.html). ## **Conclusion** Although industry has made some strides in sodium reduction, the interim results show much work remains to meet the 2025 SWA targets. By auditing your products, prioritizing popular SKUs, and adopting gradual reformulation, you can achieve compliance and strengthen your brand’s reputation for health-focused innovation. [Contact us](https://qualitysmartsolutions.com/contact) to connect with Quality Smart Solutions’ regulatory compliance experts and design a sodium reduction roadmap that aligns with Health Canada’s guidelines. 0/5 (0 Reviews) ![Picture of Andrew Parshad](https://qualitysmartsolutions.com/wp-content/uploads/2024/02/andrew-parshad_avatar-300x300.jpg) Andrew Parshad Andrew Parshad is President, CEO and founder of Quality Smart Solutions, a North American compliance solutions provider offering regulatory and quality assurance services to comply with FDA & Health Canada brands and ingredients regulations in the categories of dietary supplements, foods, cosmetics, OTC drugs and medical devices. Andrew started Quality Smart Solutions in 2007. Since that time he and his firm has served thousands of clients worldwide . 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By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## NDI Notification Services [Skip to content](https://qualitysmartsolutions.com/services/usa-supplements-ndin#content) # New Dietary Ingredient Notification (NDIN) The Food and Drug Administration (FDA) is responsible for ensuring that all food additives, including dietary ingredients and processing aids, are safe for use in foods. The FDA has established a process for notifying the agency of new dietary ingredients (NDIs) that are intended to be used as food additives or processing aids in the United States. This page gives a brief overview of this process, which can be confusing due to its complexity. We provide expert advice on New Dietary Ingredients, full dossier preparation for New Dietary Ingredient Notifications and quick support for FDA pre-submission meetings and responding to FDA questions! [Book Free Consultation!](https://qualitysmartsolutions.com/services/usa-supplements-ndin#enqy_form_sub) ## New Dietary Ingredient (NDI) The FD & C Act defines New Dietary Ingredients (NDIs) as ingredients that were not marketed in the [**US in a dietary supplement**](https://qualitysmartsolutions.com/dietary-supplement-regulation-fda/) before October 15, 1994. Any manufacturer or distributor tending to market [**dietary supplements**](https://qualitysmartsolutions.com/dietary-supplement-regulation-fda/) with ‘New Dietary Ingredients’ (NDI) in the US, must submit a notification about these ingredients to the FDA. **NDI Requirements** \- A new dietary ingredient must adhere to two requirements: 1. They must have been present in the food supply and should not be chemically altered. 2. The source of evidence (history of use or safety evidence) includes published articles, scientific literature. Other forms of evidence may be accepted by the FDA. ## New Dietary Ingredient Notification (NDIN) If you are planning to launch your product containing NDIs for commercial circulation in the US, you need to submit a premarket New Dietary Ingredient Notification (NDIN) to the FDA. - The application must be submitted at least 75 days before the proposed date of the NDI introduction to the market. - Your NDIN must contain the information that proves the safety of the ingredient. ![New Dietary Ingredient Notification (NDIN)](https://qualitysmartsolutions.com/wp-content/uploads/2021/03/new_ingredient_submission.jpg) ## What is NDI? A new dietary ingredient (NDI) is a dietary ingredient that was not sold in the U.S. as a dietary supplement before October 15, 1994. NDIs are regulated by the FDA under section 413(a) of the Federal Food, Drug, and Cosmetic Act (FDCA). NDIs are not common in the U.S., but some examples include certain probiotics, dendrobium stem extract, and pomegranate extracts. Under section 413(a)(1)(A) of FDCA (21 U.S.C.), NDI notification is required if an ingredient or product: - Contains a dietary substance for which there is no history of consumption OR - Has been present in traditional food consumed by large populations outside the United States OR - Is significantly derived from a plant/animal source with no history of consumption as a food OR - May be chemically synthesized or derived from naturally occurring substances **What constitutes a new dietary ingredient?** 1. Something that was not marketed in the United States before October 15, 1994, is considered an NDI. This date was chosen because it was the date by which manufacturers should have been able to submit their first notifications to the FDA with information about the safety and nutritional value of their new ingredient. 2. A dietary ingredient for which there is no history of use or other evidence of safety sufficient to establish general recognition of safety by qualified experts under conditions prescribed or recommended in its proposed labeling (section 201(s) (21 U.S.C., § 321(s))). 3. A substance from botanicals, vitamins, minerals, or amino acids that have not been frequently consumed as part of an unprocessed diet; this includes ingredients derived from algae such as DHA and EPA found in fish oil supplements. **What are some examples of substances that are considered NDIs?** Examples of substances that are considered NDIs include: - Food additives, such as coloring agents and preservatives - Vitamins and minerals - Botanicals, such as carotene (a precursor to vitamin A), folic acid (a B vitamin), probiotics, aminos acids, protein concentrates, natural and artificial flavors/flavors enhancers - Dietary fiber and polyols (e.g., sorbitol) ![Who needs a NDI Notification?](https://qualitysmartsolutions.com/wp-content/uploads/2022/12/QSS-Images-7.webp) ## Who needs an NDI Notification (NDIN)? Anyone who wants to use a new dietary ingredient (NDI) in food should file an NDI Notification (NDIN) to the FDA. This includes: - Manufacturers, importers, packagers, processors, and distributors of foods that contain NDIs - Dietary supplement manufacturers or distributors (not required for dietary supplements) - Food ingredients that were marketed prior to January 1, 1997, that are not generally recognized as safe (GRAS). Some of these may be exempt from filing an NDIN under certain circumstances; check the FDA website for more information on filing exemptions. The agency has posted guidance materials on its website. If you have questions about submitting an NDI notification electronically, self-affirming your notice, or other aspects of the process please visit The FDA NDI Notifications Page. ## The NDI Notification Process A notification is a letter to FDA that describes a new substance and its use in food. The notification must be submitted well before your company intends to use the NDI on food products, to allow the agency time to review the information and decide whether it needs additional information from you. It can take several months for FDA to respond if further details about your product are needed. The notification includes: - Information about the new ingredient (e.g., what it is made of and how much of it will be used) - Information about who manufactured or imported the ingredient (manufacturer, distributor, and importer) - How much of each type of food might contain this ingredient ## What happens after the NDI notification is submitted? The FDA will review your NDI Notification and issue an NDI notification letter. You may receive one of the following letters: - Letter of No Objection: This means that the FDA has no objections to your product’s being marketed in its current form. You can begin marketing your product immediately (assuming there are no other restrictions or requirements). - Letter of Objection: This means that the FDA does have objections to some aspect(s) of how you plan to market your product, but not necessarily to all aspects. For example, it might object only if you intend for this ingredient/product to be used in a way not authorized by law; however, it would not object if you were selling it as an herb or dietary supplement with a label claim such as “supports immune health.” In this case, you would need to comply with any requests made by the agency regarding how this ingredient/product must be labeled and advertised before they would allow its marketing without further objections raised by them first (if ever). ![NDIN Submission](https://qualitysmartsolutions.com/wp-content/uploads/2022/12/QSS-Images-8.webp) ## Why the Need for An NDIN Consultant? The notification process is quite lengthy and the new revisions drafted in the 2016 guidance made the paperwork even more complex and confusing. Therefore, along with basic knowledge of NDIN, you must be aware of the FDA’s view on NDINs over time, criteria to choose [**NDIN over GRAS**](https://qualitysmartsolutions.com/blog/gras-or-ndi-factors-to-consider/) and regulatory analysis of the Food Ingredients under the DSHEA 1994.” ![New Dietary Ingredient Notification](https://qualitysmartsolutions.com/wp-content/uploads/2021/03/form_submsission.jpg) ## Changes in the NDIN Submission Process Note that as of October 19, 2019, notifications are not being accepted via the **[FURLS](https://qualitysmartsolutions.com/medical-device-facility-registration-furls-listing/)** portal. All notifications are now submitted in COSM. So, submitting notifications (timeframe, format, and method submission) is complex. The occurrence of misinterpreting the Regulatory requirements will result in a product recall. When you partner with us, we will help you: - Ensure whether your ingredient is a New Dietary Ingredient - Analyze documentation gaps and point out if any other data is required - Complete a full dossier for a New Dietary Ingredient Notification (NDIN) - Prepare and request an FDA pre-submission meeting Apart from this, our experts will also help you understand the NDIN process and timeline. You will be able to meet requirements for notification to the FDA, including which documents are to be submitted. You will also become familiar with the submission modes and post-submission NDIN process. NDI notifications are required for all substances that are not generally recognized as safe (GRAS). Once you have submitted an NDI Notification, the FDA has 180 days (e.g., six months) to make a determination on whether the notification is complete and meets all of the criteria. If it does, then your ingredient can be used in supplements and foods without prior approval from the agency. [Click here for more on food clarification of GRAS & NDI Ingredients.](https://qualitysmartsolutions.com/blog/gras-vs-ndi-clarification-everything-you-should-know/) 0/5 (0 Reviews) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## FDA Medical Device Guidance [Skip to content](https://qualitysmartsolutions.com/news/fda-issues-guidance-exempting-certain-unclassified-medical-devices-from-510k-premarket-review#content) # FDA Issues Guidance Exempting Certain Unclassified Medical Devices from 510(k) Premarket Review - July 3, 2026 Last updated: July 6, 2026 - Written by [Gautamee Chaudry Thyagraj](https://qualitysmartsolutions.com/news/fda-issues-guidance-exempting-certain-unclassified-medical-devices-from-510k-premarket-review#gbio) - Regulatory Affairs Solutions Specialist - Tags:[510k](https://qualitysmartsolutions.com/tag/510k/), [Compliance](https://qualitysmartsolutions.com/tag/compliance/), [Device Classification](https://qualitysmartsolutions.com/tag/device-classification/), [FDA](https://qualitysmartsolutions.com/tag/fda/), [medical devices](https://qualitysmartsolutions.com/tag/medical-devices/), [Premarket Notification](https://qualitysmartsolutions.com/tag/premarket-notification/), [regulatory guidance](https://qualitysmartsolutions.com/tag/regulatory-guidance/) - [FDA](https://qualitysmartsolutions.com/news/fda-news/), [Medical Devices](https://qualitysmartsolutions.com/news/medical-devices-news/), [News](https://qualitysmartsolutions.com/news/) FDA Issues Guidance Exempting Certain Unclassified Medical Devices from 510(k) Premarket Review - July 3, 2026 - [510k](https://qualitysmartsolutions.com/tag/510k/), [Compliance](https://qualitysmartsolutions.com/tag/compliance/), [Device Classification](https://qualitysmartsolutions.com/tag/device-classification/), [FDA](https://qualitysmartsolutions.com/tag/fda/), [medical devices](https://qualitysmartsolutions.com/tag/medical-devices/), [Premarket Notification](https://qualitysmartsolutions.com/tag/premarket-notification/), [regulatory guidance](https://qualitysmartsolutions.com/tag/regulatory-guidance/) ![](https://qualitysmartsolutions.com/wp-content/uploads/2026/04/gautamee-choudry-thyagraj_avatar-96x96.jpg) [Gautamee Choudry Thyagraj](https://qualitysmartsolutions.com/news/fda-issues-guidance-exempting-certain-unclassified-medical-devices-from-510k-premarket-review#gbio) ## In This Article: ![FDA guidance document on unclassified medical devices exempt from 510(k) requirements](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/510k-exemption-unclassified-medical-devices.webp) The U.S. Food and Drug Administration has released guidance clarifying regulatory expectations for unclassified medical devices and 510(k)premarket notification requirements, formally exempting certain device types from the traditional premarket review pathway. The move is intended to reduce regulatory burden on manufacturers of lower-risk products that the agency has determined do not require full 510(k) clearance before entering the U.S. market. For device manufacturers, the updated guidance has immediate operational significance. Companies marketing products that fall into the agency’s list of exempted device types may no longer need to submit a 510(k) premarket notification, potentially shortening time-to-market and reducing compliance costs. However, the exemption carries specific conditions and limitations that firms must understand before adjusting their regulatory strategies. ## **What the FDA Guidance Covers** The [FDA guidance document](https://www.fda.gov/media/89238/download) addresses the regulatory status of preamendment devices – those that were on the market before the Medical Device Amendments of 1976 – that have not yet been formally classified by the agency into Class I, II, or III. Under Section 510(k) of the Federal Food, Drug, and Cosmetic Act, manufacturers are generally required to submit a premarket notification demonstrating that a device is substantially equivalent to a legally marketed predicate device before commercial distribution. The guidance specifies that certain unclassified preamendment devices may be exempt from 510(k) requirements when the FDA determines that such review is not necessary to provide reasonable assurance of safety and effectiveness. This determination is made on a case-by-case basis, taking into account the risk profile of the device type, its history of safe use, and the availability of alternative regulatory controls such as general controls under Class I. ## **Which Devices Are Affected** The exemption does not apply broadly to all unclassified devices. Rather, it targets specific product types that the agency has evaluated and determined pose sufficiently low risk. Manufacturers should consult the FDA’s product classification database and the guidance itself to confirm whether their specific device type qualifies. The agency has historically maintained a list of exempt device types through regulation, and this guidance provides additional clarity on how firms should interpret their obligations when a device has not been formally classified. Importantly, even when a device qualifies for 510(k) exemption, manufacturers remain subject to other applicable FDA requirements, including facility registration, device listing, quality system regulations under 21 CFR Part 820, and adverse event reporting through the Medical Device Reporting system. The exemption from premarket notification does not equate to an exemption from all regulatory oversight. ## **Conditions and Limitations of the Exemption** The FDA’s guidance sets clear boundaries around the scope of the exemption. A device that would otherwise qualify may still require a 510(k) submission if it has been significantly changed or modified in a way that could affect its safety or effectiveness. This includes changes to intended use, fundamental design modifications, or the introduction of new materials or energy sources not present in the original preamendment device. Additionally, the guidance reaffirms that combination products, devices incorporating drug or biologic components, and devices intended for uses that differ from the original preamendment indication are not eligible for this exemption pathway. Manufacturers must carefully assess their product’s characteristics and intended use against the criteria outlined in the guidance before concluding that a 510(k) submission is unnecessary. ## **Context Within Broader FDA Modernization Efforts** This guidance aligns with the FDA’s broader effort to modernize the medical device regulatory framework. The agency has increasingly focused on risk-based classification to allocate review resources more efficiently, directing greater scrutiny toward higher-risk devices while reducing unnecessary regulatory requirements for those that present minimal patient risk. The approach reflects a principle embedded in the 21st Century Cures Act and subsequent FDA initiatives aimed at streamlining device pathways without compromising public health protections. For manufacturers of unclassified medical devices, the 510(k) exemption guidance represents a practical outcome of this policy direction. By formally documenting the conditions under which premarket notification is not required, the agency provides greater predictability for companies planning their U.S. market entry strategies. ## **What This Means for Your Business** Device manufacturers currently marketing or planning to market products that fall within the scope of this guidance should evaluate their regulatory filing strategies in light of the updated requirements. For companies whose products qualify, the exemption from 510(k) premarket notification can translate into meaningful reductions in both time and cost associated with bringing a device to market in the United States. However, firms should approach this evaluation with care. Misinterpreting the exemption criteria, or failing to account for product modifications that trigger a 510(k) requirement, can result in marketing a device without proper authorization. Such non-compliance carries enforcement risk, including warning letters, product seizure, and import alerts. Quality Smart Solutions advises companies to conduct a thorough regulatory assessment before relying on the exemption, particularly for devices that have undergone design changes since their original market introduction. Companies with international portfolios should also consider how their U.S. classification status interacts with regulatory requirements in other jurisdictions. A device exempt from 510(k) in the United States may still require premarket authorization under Health Canada’s Medical Devices Regulations or the EU’s Medical Device Regulation (MDR). Coordination across markets is essential to avoid gaps in compliance. ## Frequently Asked Questions ### Does this exemption apply to all medical devices that have not been classified by the FDA? This is a common point of confusion, but the exemption does not apply universally to every unclassified device. It specifically addresses certain preamendment devices that the FDA has determined present sufficiently low risk to warrant exemption from 510(k) premarket notification. Manufacturers must verify their product’s eligibility by consulting the FDA’s product classification database and the conditions outlined in the guidance document. Devices that have been modified in ways affecting safety or effectiveness, or those with new intended uses, remain subject to 510(k) requirements regardless of their original classification status. ### If my device is exempt from 510(k), does that mean the FDA will not regulate it at all? Many manufacturers initially assume that exemption from 510(k) means exemption from all FDA oversight, but that is not the case. Even when premarket notification is not required, manufacturers must still comply with establishment registration, device listing, current good manufacturing practice requirements under 21 CFR Part 820, labelling requirements, and Medical Device Reporting obligations. The exemption removes one specific premarket step but leaves all other applicable regulatory controls in place. Failure to meet these ongoing obligations can still result in FDA enforcement action. ### How should companies determine whether a product modification triggers a new 510(k) requirement for an otherwise exempt device? This is one of the more challenging assessments manufacturers face. The FDA’s guidance indicates that significant changes to a device’s design, materials, intended use, or energy source can remove a product from exempt status and require a new 510(k) submission. Companies should document their change assessment process and apply the principles outlined in FDA’s guidance on deciding when to submita 510(k) for changes to an existing device. When the determination is not straightforward, seeking a pre-submission meeting with the FDA or consulting with a regulatory specialist can help clarify the filing obligation before a compliance gap arises. ## **Key Takeaways** - The FDA has issued guidance exempting certain unclassified preamendment medical devices from 510(k) premarket notification requirements, targeting lower-risk product types. - The exemption applies only to specific device categories and does not extend to products that have been significantly modified or that incorporate drug or biologic components. - Manufacturers remain subject to all other FDA requirements, including facility registration, device listing, quality system regulations, and adverse event reporting. - Product modifications affecting safety, effectiveness, or intended use can disqualify a device from the exemption and trigger a 510(k) filing obligation. - Companies should conduct a formal regulatory assessment to confirm eligibility before relying on the exemption for any U.S. market strategy. ## **Looking Ahead** The FDA’s guidance on unclassified medical devices and 510(k) exemptions provides welcome clarity for manufacturers, but it also places the responsibility squarely on companies to assess their own eligibility and maintain compliance with all other applicable requirements. Firms that take the time to evaluate their product portfolios against the guidance’s criteria will be better positioned to make sound regulatory decisions, whether that means proceeding without a 510(k) or recognizing that a submission is still required. For companies seeking support with medical device classification, 510(k) strategy, or regulatory pathway assessment, Quality Smart Solutions offers [medical device regulatory consulting services](https://qualitysmartsolutions.com/services/usa-medical-device-compliance/) tailored to manufacturers entering or expanding within the U.S. market. To discuss how this guidance may affect your product line, [contact Quality Smart Solutions](https://qualitysmartsolutions.com/contact/) to speak with a regulatory specialist. 0/5 (0 Reviews) ![Picture of Gautamee Choudry Thyagaraj](https://qualitysmartsolutions.com/wp-content/uploads/2021/01/Gautamee-Choudry-Headshot.jpg) Gautamee Choudry Thyagaraj Regulatory Affairs Solutions Specialist Regulatory Affairs professional with a strong background in compliance, quality systems, and medical device regulatory strategy. At Quality Smart Solutions (QSS), Gautamee contributes to practical regulatory and quality support, helping clients navigate complex requirements with clarity and structure across global markets. An RCC-MDR professional and BSI-Certified ISO 13485/MDSAP Lead Auditor, she brings a grounded focus on real-world regulatory implementation, translating complex compliance topics into clear, actionable guidance for clients and teams. Outside of work, Gautamee enjoys travelling, cooking, and exploring different cultures and histories around the world. ##### Related Articles [![FDA proposed rule addressing foreign drug manufacturer and distributed manufacturing registration](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/FDA-Drug-Manufacturing-Registration-300x157.jpg)](https://qualitysmartsolutions.com/news/fda-proposes-rule-to-close-registration-gap-for-foreign-drug-manufacturers/) ### [FDA Proposes Rule to Close Registration Gap for Foreign Drug Manufacturers](https://qualitysmartsolutions.com/news/fda-proposes-rule-to-close-registration-gap-for-foreign-drug-manufacturers/) [![TikTok Shop dietary supplement compliance requirements displayed on a mobile phone screen](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/TikTok-Shop-dietary-supplement-rules-300x157.jpg)](https://qualitysmartsolutions.com/blog/selling-dietary-supplements-on-tiktok-shop-a-compliance-requirements-guide/) ### [Selling Dietary Supplements on TikTok Shop: A Compliance Requirements Guide](https://qualitysmartsolutions.com/blog/selling-dietary-supplements-on-tiktok-shop-a-compliance-requirements-guide/) [![Veterinary health product registration in Canada for pet health companies](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/VHP-registration-in-Canada-300x157.jpg)](https://qualitysmartsolutions.com/blog/vhp-registration-in-canada-what-pet-health-companies-need-to-know/) ### [VHP Registration in Canada: What Pet Health Companies Need to Know](https://qualitysmartsolutions.com/blog/vhp-registration-in-canada-what-pet-health-companies-need-to-know/) [PrevHealth Canada Removes FPS Submission Requirement for NHP Product Licence Applications](https://qualitysmartsolutions.com/news/health-canada-removes-fps-submission-requirement-for-nhp-product-licence-applications/) [FDA Flags Data Integrity Issues at Device Testing LabsNext](https://qualitysmartsolutions.com/news/fda-flags-data-integrity-issues-at-device-testing-labs/) ###### Industries We Serve - 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[Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## MDALL Registration Guide [Skip to content](https://qualitysmartsolutions.com/blog/health-canada-mdall-medical-device-registration-guide#content) # Health Canada MDALL Medical Device Registration Guide - August 1, 2023 Last updated: December 23, 2025 - Written by - [Andrew Parshad](https://www.linkedin.com/in/andrewparshad/) - Tags:[Health Canada](https://qualitysmartsolutions.com/tag/health-canada/), [MDALL](https://qualitysmartsolutions.com/tag/mdall/), [medical devices](https://qualitysmartsolutions.com/tag/medical-devices/) - [Blog](https://qualitysmartsolutions.com/blog/), [Medical Devices](https://qualitysmartsolutions.com/blog/medical-devices/) Health Canada MDALL Medical Device Registration Guide - August 1, 2023 - [Health Canada](https://qualitysmartsolutions.com/tag/health-canada/), [MDALL](https://qualitysmartsolutions.com/tag/mdall/), [medical devices](https://qualitysmartsolutions.com/tag/medical-devices/) ![](https://qualitysmartsolutions.com/wp-content/uploads/2024/02/andrew-parshad_avatar-96x96.jpg) [Andrew Parshad](https://qualitysmartsolutions.com/blog/health-canada-mdall-medical-device-registration-guide#gbio) President & Founder of Quality Smart Solutions ## In This Article: **![Health Canada MDALL medical device registration process explained](https://qualitysmartsolutions.com/wp-content/uploads/2023/08/Health-Canada-MDALL.jpg)** ## **Introduction** Health Canada MDALL is the key to legally marketing medical devices in Canada. If you are a manufacturer looking to enter the Canadian market, this registration ensures your device is safe, effective, and compliant with national regulations. It also gives you access to a trusted database that health professionals and patients rely on to verify approved devices. In this guide, we’ll explain what MDALL is, why it matters, and how to register your device. You’ll also find common challenges, practical tips, and examples of how our team at Quality Smart Solutions can help. Keep reading to learn how to move forward with confidence. ## **What is Health Canada MDALL?** The Medical Device Active Licence Listing (MDALL) is a public database maintained by Health Canada. It contains all licensed Class II, III, and IV medical devices allowed for sale in Canada. It is updated daily and can be accessed by healthcare professionals, patients, and regulators to verify device status. [You can search the database directly here](https://health-products.canada.ca/mdall-limh/). Beyond serving as a reference tool, MDALL also helps promote transparency and accountability in the medical device industry. By making licensing information public, it allows healthcare providers and patients to make informed decisions, while encouraging manufacturers to maintain high standards of safety and compliance. ## **The Regulatory Context** Canada regulates medical devices under the Medical Devices Regulations (MDR). Devices are classified into four risk-based categories: - **Class I**: lowest risk (e.g., thermometers) - **Class II**: moderate risk (e.g., contact lenses) - **Class III**: higher risk (e.g., ventilators) - **Class IV**: highest risk (e.g., pacemakers) Most devices, except some custom-made or investigational ones, must be listed in MDALL before they can be marketed in Canada. ## **Steps to Register with Health Canada MDALL** The registration process requires careful preparation. Here’s what you need to do: 1. **Determine the classification** Identify the risk class of your device using Health Canada’s rules. This determines the documentation required. 2. **Prepare documentation** Include technical specs, intended use, labeling, safety data, and quality management evidence (ISO 13485 compliance). 3. **Submit the application** Complete and submit the Medical Device Licence Application with all supporting documentation. 4. **Pay fees** Fees depend on the risk class and application type. 5. **Health Canada review** Regulators will evaluate the submission, including safety and effectiveness data. 6. **Approval and listing** Once approved, your device will be listed in MDALL, allowing legal sales in Canada. ## **Documentation You’ll Need** - Device description and intended use - Technical specifications and standards met - Clear labeling and instructions for use - Evidence of safety and effectiveness (clinical or lab data) - Risk management documentation - Proof of ISO 13485 quality management system - Canadian representative details (if manufactured abroad) ## **Common Challenges in MDALL Registration** Manufacturers often face challenges when going through MDALL registration. One common problem is misclassifying the device’s risk level, which can cause delays and additional hurdles. Another issue is submitting incomplete or inconsistent documentation, which slows down the review process. Some companies also struggle to provide strong evidence of safety or effectiveness, making it harder for Health Canada to approve the device. Risk management can be another weak point if it is not thorough and well documented. Finally, many applicants are unfamiliar with Health Canada’s requirements, and this lack of understanding often leads to setbacks. These challenges can cause delays or even rejections if not addressed early. ## **Tips for a Successful MDALL Registration** Preparing your MDALL application can feel complex, but there are simple ways to make the process smoother. Here are a few tips to guide you when dealing with Health Canada: - Start the process early to allow time for corrections - Keep communication open with Health Canada - Stay current with regulatory updates and guidance - Maintain ISO 13485 quality compliance - Work with regulatory experts to streamline your submission ## **How Quality Smart Solutions Helps You** Navigating Health Canada MDALL can be overwhelming. At Quality Smart Solutions, we act as your guide. Our experts help classify your device, prepare documentation, and liaise with Health Canada to ensure a smooth registration. We simplify the process so you can focus on bringing your device to market faster and with confidence. Explore our [medical device services](https://qualitysmartsolutions.com/services/canada-medical-device-compliance/) or [contact us today](https://qualitysmartsolutions.com/contact/) to discuss your project. ## **Key Takeaways** - Health Canada MDALL is mandatory for most medical devices sold in Canada. - Risk classification determines the level of documentation required. - Proper preparation reduces delays and improves approval chances. - ISO 13485 quality compliance is essential. - Expert support helps you navigate the process more efficiently. ## Frequently Asked Questions about MDALL ### Can I sell my device in Canada without MDALL? No. Marketing or selling a medical device without Health Canada MDALL registration is illegal. ### Is MDALL only for high-risk devices? No. Class II, III, and IV devices must be listed. Only Class I devices are exempt from the licensing process. ### Does the process take a long time? It depends on the device and submission quality. Simple Class II devices may be approved faster, while Class III and IV devices can take longer. ### Can foreign manufacturers apply directly? No. You need a Canadian regulatory representative to act on your behalf. ### What happens if Health Canada rejects my application? You’ll receive feedback explaining why. Once corrected, you can resubmit. ## **Next Steps** Getting your device listed with Health Canada MDALL is an important milestone on the path to entering Canada’s healthcare market. With some planning, the right documents, and steady support, you can feel confident that your device meets requirements and earns the trust of healthcare professionals and patients. Our team at Quality Smart Solutions is here to guide you every step of the way. [Contact us today](https://qualitysmartsolutions.com/contact/) to start your MDALL registration journey with clarity and confidence. 0/5 (0 Reviews) ![Picture of Andrew Parshad](https://qualitysmartsolutions.com/wp-content/uploads/2024/02/andrew-parshad_avatar-300x300.jpg) Andrew Parshad Andrew Parshad is President, CEO and founder of Quality Smart Solutions, a North American compliance solutions provider offering regulatory and quality assurance services to comply with FDA & Health Canada brands and ingredients regulations in the categories of dietary supplements, foods, cosmetics, OTC drugs and medical devices. Andrew started Quality Smart Solutions in 2007. Since that time he and his firm has served thousands of clients worldwide . Andrew's affiliate company, Quality IMPORT Solutions that offers import agent services into the Canadian market as a government licensed importer for foods, dietary supplements and medical devices. ##### Related Articles [![FDA proposed rule addressing foreign drug manufacturer and distributed manufacturing registration](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/FDA-Drug-Manufacturing-Registration-300x157.jpg)](https://qualitysmartsolutions.com/news/fda-proposes-rule-to-close-registration-gap-for-foreign-drug-manufacturers/) ### [FDA Proposes Rule to Close Registration Gap for Foreign Drug Manufacturers](https://qualitysmartsolutions.com/news/fda-proposes-rule-to-close-registration-gap-for-foreign-drug-manufacturers/) [![TikTok Shop dietary supplement compliance requirements displayed on a mobile phone screen](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/TikTok-Shop-dietary-supplement-rules-300x157.jpg)](https://qualitysmartsolutions.com/blog/selling-dietary-supplements-on-tiktok-shop-a-compliance-requirements-guide/) ### [Selling Dietary Supplements on TikTok Shop: A Compliance Requirements Guide](https://qualitysmartsolutions.com/blog/selling-dietary-supplements-on-tiktok-shop-a-compliance-requirements-guide/) [![Veterinary health product registration in Canada for pet health companies](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/VHP-registration-in-Canada-300x157.jpg)](https://qualitysmartsolutions.com/blog/vhp-registration-in-canada-what-pet-health-companies-need-to-know/) ### [VHP Registration in Canada: What Pet Health Companies Need to Know](https://qualitysmartsolutions.com/blog/vhp-registration-in-canada-what-pet-health-companies-need-to-know/) [PrevHow to Secure a Natural Product Number in Canada](https://qualitysmartsolutions.com/blog/navigating-the-health-canada-npn-process-a-step-by-step-guide/) [Navigating the regulatory landscape: Understanding the Importance of a Generally Recognized as Safe DatabaseNext](https://qualitysmartsolutions.com/blog/navigating-the-regulatory-landscape-understanding-the-importance-of-a-generally-recognized-as-safe-database/) ###### Industries We Serve - 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[Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## FDA AI Device Guidelines [Skip to content](https://qualitysmartsolutions.com/news/fdas-2026-ai-medical-device-guidance-signals-new-expectations-for-manufacturers#content) # FDA’s 2026 AI Medical Device Guidance Signals New Expectations for Manufacturers - June 18, 2026 Last updated: June 18, 2026 - Written by [Gautamee Chaudry Thyagraj](https://qualitysmartsolutions.com/news/fdas-2026-ai-medical-device-guidance-signals-new-expectations-for-manufacturers#gbio) - Regulatory Affairs Solutions Specialist - Tags:[AI Medical Devices](https://qualitysmartsolutions.com/tag/ai-medical-devices/), [FDA](https://qualitysmartsolutions.com/tag/fda/), [Health Canada](https://qualitysmartsolutions.com/tag/health-canada/), [Machine Learning](https://qualitysmartsolutions.com/tag/machine-learning/), [Medical Device Guidance](https://qualitysmartsolutions.com/tag/medical-device-guidance/), [Predetermined Change Control Plan](https://qualitysmartsolutions.com/tag/predetermined-change-control-plan/), [regulatory affairs](https://qualitysmartsolutions.com/tag/regulatory-affairs/), [Regulatory Compliance](https://qualitysmartsolutions.com/tag/regulatory-compliance/), [SaMD](https://qualitysmartsolutions.com/tag/samd/) - [FDA](https://qualitysmartsolutions.com/news/fda-news/), [Medical Devices](https://qualitysmartsolutions.com/news/medical-devices-news/), [News](https://qualitysmartsolutions.com/news/) FDA’s 2026 AI Medical Device Guidance Signals New Expectations for Manufacturers - June 18, 2026 - [AI Medical Devices](https://qualitysmartsolutions.com/tag/ai-medical-devices/), [FDA](https://qualitysmartsolutions.com/tag/fda/), [Health Canada](https://qualitysmartsolutions.com/tag/health-canada/), [Machine Learning](https://qualitysmartsolutions.com/tag/machine-learning/), [Medical Device Guidance](https://qualitysmartsolutions.com/tag/medical-device-guidance/), [Predetermined Change Control Plan](https://qualitysmartsolutions.com/tag/predetermined-change-control-plan/), [regulatory affairs](https://qualitysmartsolutions.com/tag/regulatory-affairs/), [Regulatory Compliance](https://qualitysmartsolutions.com/tag/regulatory-compliance/), [SaMD](https://qualitysmartsolutions.com/tag/samd/) ![](https://qualitysmartsolutions.com/wp-content/uploads/2026/04/gautamee-choudry-thyagraj_avatar-96x96.jpg) [Gautamee Choudry Thyagraj](https://qualitysmartsolutions.com/news/fdas-2026-ai-medical-device-guidance-signals-new-expectations-for-manufacturers#gbio) ## In This Article: ![FDA 2026 AI medical device guidance document overview for manufacturers](https://qualitysmartsolutions.com/wp-content/uploads/2026/06/FDA-AI-medical-device-guidance.jpg) The U.S. Food and Drug Administration has released updated [guidance for AI-enabled medical devices](https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices) that reshapes how manufacturers must approach the development, validation, and lifecycle management of artificial intelligence and machine learning-enabled medical devices. Building on several years of draft frameworks, the FDA’s 2026 regulatory posture consolidates clearer expectations around transparency, real-world performance monitoring, and predetermined change control plans (PCCPs). It is important to note that not all elements of this framework are finalized. The August 2025 final PCCP guidance is fully in effect. The January 2025 draft guidance on AI-enabled device software functions and lifecycle management remains in draft form, pending finalization. Manufacturers should treat the draft guidance as a strong signal of regulatory direction, while recognizing that certain specifics may evolve before the final version is issued. For manufacturers already marketing AI-enabled devices or preparing submissions, these developments introduce specific documentation and post-market requirements that will affect both regulatory strategy and operational workflows. The guidance applies broadly to software as a medical device (SaMD) that incorporates AI or machine learning functionality, though higher-risk devices face more stringent expectations. ## **What the Guidance Covers** The FDA’s current AI regulatory framework for medical devices draws from three interconnected streams: the August 2025 final PCCP guidance, the January 2025 draft guidance on AI-enabled device software functions and lifecycle management, and the June 2024 transparency guiding principles for machine learning-enabled devices. Together, these documents cover the total product lifecycle (TPLC) approach for AI/ML-based SaMD, PCCP requirements, and transparency and bias mitigation obligations. One of the most consequential elements is the finalized PCCP framework. Under the August 2025 final guidance, manufacturers submitting premarket applications for AI/ML devices must include a detailed predetermined change control plan that specifies the types of modifications the algorithm may undergo after clearance or approval, the methodology for validating those modifications, and the performance boundaries within which changes may occur without requiring a new submission. This codifies what had previously been a loosely defined expectation into a structured, auditable requirement. ## **Transparency and Labelling Requirements** The draft lifecycle management guidance introduces more prescriptive transparency obligations. Manufacturers are expected to include specific information describing the data used to train and validate the AI model, including the demographic composition of training datasets. The FDA has framed this as a measure to address algorithmic bias and to give clinicians meaningful context for interpreting AI-generated outputs. Labeling must also clearly communicate the intended use conditions under which the device has been validated, as well as any known limitations of the algorithm’s performance across different patient populations or clinical settings. These expectations go beyond what many manufacturers have historically included in their labeling, and companies should begin assessing their current practices against this direction now, even before the draft guidance is finalized. ## **Real-World Performance Monitoring** Another significant addition in the draft guidance is the formalization of post-market real-world performance monitoring expectations. Manufacturers of AI/ML-enabled devices are expected to establish ongoing monitoring programs that track device performance using real-world data. This includes monitoring for model drift, which occurs when an algorithm’s accuracy degrades over time as patient populations or clinical practices change. The draft guidance does not mandate a specific monitoring methodology but identifies several acceptable approaches, including the use of electronic health record data, device output logging, and structured feedback from clinical users. Manufacturers are expected to document their monitoring approach in their quality management system and to demonstrate during post-market surveillance reviews that they are actively tracking algorithmic performance. ## **Predetermined Change Control Plans in Detail** The finalized PCCP framework deserves particular attention because it directly affects how manufacturers plan their product development roadmaps. Under the August 2025 final guidance, a PCCP must define three components with specificity. First, the description of modifications outlines the types of changes the manufacturer anticipates making, such as retraining the model on new data or adjusting decision thresholds. Second, the modification protocol details the verification and validation activities that will be performed before implementing any change. Third, the impact assessment describes how the manufacturer will evaluate whether a given change falls within the scope of the approved PCCP or requires a new regulatory submission. This framework provides a pathway for iterative algorithm improvement without the burden of filing a new 510(k) or premarket approval supplement for every update. However, it places the responsibility on manufacturers to define their change boundaries with precision at the time of initial submission. Vague or overly broad PCCPs are likely to draw additional scrutiny from FDA reviewers. ## **What This Means for Your Business** For companies developing or marketing AI-enabled medical devices, the practical impact spans multiple functions. Regulatory affairs teams will need to revise submission strategies to incorporate detailed PCCPs in close collaboration with data science and engineering teams. Quality assurance teams will need to update quality management systems to include real-world performance monitoring protocols, and labeling teams should prepare for more detailed transparency disclosures. Companies with legacy AI/ML devices already on the market should begin assessing their current labeling against the draft guidance now, even before finalization. Firms operating in both U.S. and Canadian markets should also note that the QMSR came into effect February 2, 2026, aligning U.S. quality system requirements with ISO 13485:2016, and that Health Canada continues to align with international AI/ML frameworks through the IMDRF, meaning FDA compliance investments may carry parallel benefits for Canadian filings. Quality Smart Solutions recommends treating this regulatory direction as an operational planning milestone, not a distant concern. Compliance preparation should begin well before submission timelines. ## Frequently Asked Questions ### Does the current guidance apply to AI devices that already have FDA clearance? The finalized PCCP guidance applies to new marketing submissions. The transparency and labeling expectations outlined in the draft lifecycle management guidance are expected to apply to legacy devices as well, though the FDA has indicated a phased compliance timeline for already-cleared devices. The specific deadlines will vary depending on device risk classification, and manufacturers should monitor for the finalized version of the draft guidance, which will confirm the compliance schedule. ### How specific does a predetermined change control plan need to be at the time of submission? The August 2025 final PCCP guidance makes clear that overly broad or vaguely defined change descriptions are unlikely to be accepted. A compliant PCCP must detail the specific categories of anticipated modifications, the validation methodology for each, and the quantitative performance boundaries that define whether a change remains within scope. Manufacturers should engage their data science and regulatory teams early in development to define these parameters with enough precision to satisfy FDA reviewers while retaining room for meaningful algorithm improvement. ### Will Health Canada adopt similar requirements for AI-enabled medical devices? Health Canada has been actively participating in the IMDRF and has co-published guiding principles on PCCPs for machine learning-enabled devices alongside the FDA and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). Health Canada has also published its own guidance on transparency for machine learning-enabled devices. Manufacturers selling into both markets should design their compliance programs to satisfy both jurisdictions from the outset, as the regulatory frameworks continue to converge. ## **Key Takeaways** - The FDA’s August 2025 final PCCP guidance is in effect, requiring detailed change control plans in new AI/ML device marketing submissions. - The January 2025 draft guidance on AI-enabled device lifecycle management remains in draft form; manufacturers should treat it as a strong indicator of regulatory direction. - Predetermined change control plans must be specific at the time of initial submission, defining modification types, validation protocols, and performance boundaries. - Transparency and labeling expectations call for disclosure of training data demographics, intended use conditions, and known algorithmic limitations. - Real-world performance monitoring programs are an explicit expectation in the draft guidance, with manufacturers expected to track model drift and document their approach within their quality management system. - The QMSR came into effect February 2, 2026, aligning U.S. quality system requirements with ISO 13485:2016. - Health Canada is actively aligning with international AI/ML device frameworks; manufacturers in both markets should plan for converging requirements. ## **Looking Ahead** The FDA’s evolving AI medical device framework marks a substantive shift in how regulators expect manufacturers to manage the full lifecycle of AI-enabled products. Companies that align their regulatory, quality, and data science functions now will be in a stronger position to meet submission and post-market requirements without delays. For manufacturers seeking support in preparing PCCP documentation, updating quality management systems, or aligning U.S. and Canadian regulatory strategies, [contact Quality Smart Solutions](https://qualitysmartsolutions.com/contact/) to speak with a regulatory specialist. 0/5 (0 Reviews) ![Picture of Gautamee Choudry Thyagaraj](https://qualitysmartsolutions.com/wp-content/uploads/2021/01/Gautamee-Choudry-Headshot.jpg) Gautamee Choudry Thyagaraj Regulatory Affairs Solutions Specialist Regulatory Affairs professional with a strong background in compliance, quality systems, and medical device regulatory strategy. At Quality Smart Solutions (QSS), Gautamee contributes to practical regulatory and quality support, helping clients navigate complex requirements with clarity and structure across global markets. An RCC-MDR professional and BSI-Certified ISO 13485/MDSAP Lead Auditor, she brings a grounded focus on real-world regulatory implementation, translating complex compliance topics into clear, actionable guidance for clients and teams. Outside of work, Gautamee enjoys travelling, cooking, and exploring different cultures and histories around the world. ##### Related Articles [![FDA proposed rule addressing foreign drug manufacturer and distributed manufacturing registration](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/FDA-Drug-Manufacturing-Registration-300x157.jpg)](https://qualitysmartsolutions.com/news/fda-proposes-rule-to-close-registration-gap-for-foreign-drug-manufacturers/) ### [FDA Proposes Rule to Close Registration Gap for Foreign Drug Manufacturers](https://qualitysmartsolutions.com/news/fda-proposes-rule-to-close-registration-gap-for-foreign-drug-manufacturers/) [![TikTok Shop dietary supplement compliance requirements displayed on a mobile phone screen](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/TikTok-Shop-dietary-supplement-rules-300x157.jpg)](https://qualitysmartsolutions.com/blog/selling-dietary-supplements-on-tiktok-shop-a-compliance-requirements-guide/) ### [Selling Dietary Supplements on TikTok Shop: A Compliance Requirements Guide](https://qualitysmartsolutions.com/blog/selling-dietary-supplements-on-tiktok-shop-a-compliance-requirements-guide/) [![Veterinary health product registration in Canada for pet health companies](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/VHP-registration-in-Canada-300x157.jpg)](https://qualitysmartsolutions.com/blog/vhp-registration-in-canada-what-pet-health-companies-need-to-know/) ### [VHP Registration in Canada: What Pet Health Companies Need to Know](https://qualitysmartsolutions.com/blog/vhp-registration-in-canada-what-pet-health-companies-need-to-know/) [PrevHealth Canada Amends Prescription Drug List to Require a Prescription for Pediatric Melatonin Use](https://qualitysmartsolutions.com/news/health-canada-amends-prescription-drug-list-to-require-a-prescription-for-pediatric-melatonin-use/) [FDA Advances Post-Market Review of Phthalates Used in Food Contact MaterialsNext](https://qualitysmartsolutions.com/news/fda-advances-post-market-review-of-phthalates-used-in-food-contact-materials/) ###### Industries We Serve - 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[Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## EFSA Novel Food Changes [Skip to content](https://qualitysmartsolutions.com/blog/7-must-know-efsa-novel-food-regulation-changes-for-2025-you-need-to-be-ready#content) # 7 Must-Know EFSA Novel Food Regulation Changes for 2025: You Need To Be Ready - October 17, 2024 Last updated: December 29, 2025 - Written by - [Andrew Parshad](https://www.linkedin.com/in/andrewparshad/) - [Blog](https://qualitysmartsolutions.com/blog/) 7 Must-Know EFSA Novel Food Regulation Changes for 2025: You Need To Be Ready - October 17, 2024 ![](https://qualitysmartsolutions.com/wp-content/uploads/2024/02/andrew-parshad_avatar-96x96.jpg) [Andrew Parshad](https://qualitysmartsolutions.com/blog/7-must-know-efsa-novel-food-regulation-changes-for-2025-you-need-to-be-ready#gbio) President & Founder of Quality Smart Solutions ## In This Article: ![EFSA novel food regulation changes](https://qualitysmartsolutions.com/wp-content/uploads/2024/10/novel-food-regulations.jpg)Are your novel food products ready for the new [European Food Safety Authority (EFSA)](https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2024.8966) regulations? If you’re planning to enter the European market in 2025, significant updates to the EFSA novel food regulatory framework are on the horizon, effective from February 1, 2025. These changes will affect everything from risk assessments to labelling, sustainability, and more. Staying ahead of these updates could be the difference between success and costly delays. This guide breaks down the fundamental regulatory changes and how your business can prepare for them. Plus, we’ll reveal how the common industry practice of partnering with experts can help you navigate these complex updates smoothly and avoid potential roadblocks. Keep reading to learn more. ## What are these new EFSA Regulations? ### **1\. Stricter Risk Assessments for Novel Foods** EFSA is raising the bar for safety and scientific evaluation, particularly for products developed using new technologies such as nanomaterials or synthetic biology. These updates require companies to submit comprehensive toxicological, allergenic, and nutritional data supported by long-term studies. If your novel food uses innovative production methods or bioactive compounds, you’ll need a robust evidence package that demonstrates product safety over time. ### **2\. Simplified Process for Traditional Foods from Non-EU Countries** There’s some good news for manufacturers introducing traditional foods from outside the EU. EFSA will now streamline the approval process for foods with a proven record of safe use. This means that products demonstrating at least 25 years of safe consumption in non-EU markets will qualify for a fast-tracked evaluation, reducing both review time and administrative burden. This update can significantly accelerate entry into the European market for companies with long-established products. ### **3\. Transparency in the Application Process** EFSA plans to make the novel food approval process more transparent by publishing application details and evaluations in a public database. This will allow consumers, researchers, and industry peers to access information about risk assessments and approvals, increasing both trust and accountability in the food innovation sector. ### **4\. Stricter Labeling and Health Claims Regulations** Misleading or unverified health claims will face closer scrutiny. EFSA will require clearer labels that inform consumers about the food’s novel nature, allergen content, and proper preparation or consumption methods. Health and nutrition claims must be supported by strong scientific evidence to avoid product rejections or market withdrawal. Brands should review all marketing materials to ensure accuracy and compliance before launch. ### 5\. Protection of Proprietary Data While transparency is increasing, EFSA will also offer stronger protection for proprietary data submitted during the novel food application process. Companies will benefit from a five-year data exclusivity period, preventing competitors from using their research to obtain similar approvals. This gives applicants a competitive edge and safeguards their R&D investment. ### **6\. Sustainability Takes Center Stage** For the first time, sustainability metrics will play a central role in EFSA’s assessment process. Foods developed through eco-friendly practices, such as alternative proteins, fermentation, or insect-based products, will receive additional consideration. Manufacturers are encouraged to quantify and communicate their environmental impact, including carbon footprint or resource efficiency, to strengthen their applications and align with Europe’s broader green transition goals. ### 7\. Increased Scrutiny of Supplements Supplement manufacturers should prepare for tighter controls on novel ingredients and bioactive compounds. EFSA will introduce upper safety limits and require mandatory usage warnings to protect consumers from overconsumption. These updates mean supplement labels must clearly outline dosage, duration of use, and safety precautions to ensure continued compliance in the EU market. ## Frequently Asked Questions ### Do I need new safety studies for already approved products? If your novel food includes new technology or production processes, you will need updated safety data that aligns with EFSA’s enhanced criteria. ### How do I prove my food has been consumed safely for 25 years? You must provide documented evidence like historical records, studies, or testimonials from recognized institutions. ### What happens if my product label is misleading? EFSA could reject or remove your product from the market, costing you time and money. Avoid exaggerated claims by relying on robust scientific evidence. ### Can sustainability give my product an edge? Absolutely! Emphasizing low environmental impact practices aligns your product with EFSA’s sustainability goals and may lead to a priority review. ## Next Steps Adapting to [EFSA’s new framework](https://www.efsa.europa.eu/en/news/navigating-novel-foods-what-efsas-updated-guidance-means-safety-assessments) requires time, strategy, and expertise. At Quality Smart Solutions, we help food and supplement manufacturers navigate the complex EU regulatory landscape — from safety study design and novel food dossier preparation to sustainability documentation and labelling compliance. Our regulatory experts have helped clients successfully bring novel ingredients and traditional foods to the European market, ensuring full compliance with EFSA’s evolving standards. Now is the time to assess whether your novel food products meet the upcoming requirements and secure your place in the EU market before the new rules take effect. Learn more about our EFSA [Novel Food Application services](https://qualitysmartsolutions.com/services/efsa-novel-food/) or [contact us](https://qualitysmartsolutions.com/contact/) to book a free consultation with our team. 0/5 (0 Reviews) ![Picture of Andrew Parshad](https://qualitysmartsolutions.com/wp-content/uploads/2024/02/andrew-parshad_avatar-300x300.jpg) Andrew Parshad Andrew Parshad is President, CEO and founder of Quality Smart Solutions, a North American compliance solutions provider offering regulatory and quality assurance services to comply with FDA & Health Canada brands and ingredients regulations in the categories of dietary supplements, foods, cosmetics, OTC drugs and medical devices. Andrew started Quality Smart Solutions in 2007. Since that time he and his firm has served thousands of clients worldwide . Andrew's affiliate company, Quality IMPORT Solutions that offers import agent services into the Canadian market as a government licensed importer for foods, dietary supplements and medical devices. ##### Related Articles [![FDA proposed rule addressing foreign drug manufacturer and distributed manufacturing registration](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/FDA-Drug-Manufacturing-Registration-300x157.jpg)](https://qualitysmartsolutions.com/news/fda-proposes-rule-to-close-registration-gap-for-foreign-drug-manufacturers/) ### [FDA Proposes Rule to Close Registration Gap for Foreign Drug Manufacturers](https://qualitysmartsolutions.com/news/fda-proposes-rule-to-close-registration-gap-for-foreign-drug-manufacturers/) [![TikTok Shop dietary supplement compliance requirements displayed on a mobile phone screen](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/TikTok-Shop-dietary-supplement-rules-300x157.jpg)](https://qualitysmartsolutions.com/blog/selling-dietary-supplements-on-tiktok-shop-a-compliance-requirements-guide/) ### [Selling Dietary Supplements on TikTok Shop: A Compliance Requirements Guide](https://qualitysmartsolutions.com/blog/selling-dietary-supplements-on-tiktok-shop-a-compliance-requirements-guide/) [![Veterinary health product registration in Canada for pet health companies](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/VHP-registration-in-Canada-300x157.jpg)](https://qualitysmartsolutions.com/blog/vhp-registration-in-canada-what-pet-health-companies-need-to-know/) ### [VHP Registration in Canada: What Pet Health Companies Need to Know](https://qualitysmartsolutions.com/blog/vhp-registration-in-canada-what-pet-health-companies-need-to-know/) [PrevBreaking News: Health Canada’s New GMP Guide for Natural Health Products – Are You Ready?](https://qualitysmartsolutions.com/blog/breaking-news-health-canadas-new-gmp-guide-for-natural-health-products-are-you-ready/) [New Hydration Product Monographs LaunchedNext](https://qualitysmartsolutions.com/news/new-hydration-product-monographs-launched/) ###### Industries We Serve - [Natural Health Products](https://qualitysmartsolutions.com/nhp-licensing-and-consulting-experts/) - [Medical Devices](https://qualitysmartsolutions.com/medical-device-regulations-mdl-mdel/) - [Dietary Supplements](https://qualitysmartsolutions.com/dietary-supplement-regulation-fda/) - [Cosmetic Products](https://qualitysmartsolutions.com/cosmetics-regulations-compliance-services/) - [Homeopathic Products](https://qualitysmartsolutions.com/homeopathic-products-compliance/) - [Veterinary Health Products](https://qualitysmartsolutions.com/veterinary-health-products-vhp-compliance/) - [OTC Drugs](https://qualitysmartsolutions.com/otc-drug-compliance-din/) - [Canna Solutions](https://qualitysmartsolutions.com/canna-license-solutions/) ###### Related Articles [![TikTok Shop dietary supplement compliance requirements displayed on a mobile phone screen](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/TikTok-Shop-dietary-supplement-rules-300x157.jpg)](https://qualitysmartsolutions.com/blog/selling-dietary-supplements-on-tiktok-shop-a-compliance-requirements-guide/) [Selling Dietary Supplements on TikTok Shop: A Compliance Requirements Guide](https://qualitysmartsolutions.com/blog/selling-dietary-supplements-on-tiktok-shop-a-compliance-requirements-guide/) [![Veterinary health product registration in Canada for pet health companies](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/VHP-registration-in-Canada-300x157.jpg)](https://qualitysmartsolutions.com/blog/vhp-registration-in-canada-what-pet-health-companies-need-to-know/) [VHP Registration in Canada: What Pet Health Companies Need to Know](https://qualitysmartsolutions.com/blog/vhp-registration-in-canada-what-pet-health-companies-need-to-know/) [![FDA mandatory GRAS notification rule document review for food ingredient compliance](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/FDA-GRAS-Notification-300x157.jpg)](https://qualitysmartsolutions.com/news/fda-mandatory-gras-notification-rule-could-reshape-food-ingredient-compliance-by-year-end/) [FDA Mandatory GRAS Notification Rule Could Reshape Food Ingredient Compliance by Year End](https://qualitysmartsolutions.com/news/fda-mandatory-gras-notification-rule-could-reshape-food-ingredient-compliance-by-year-end/) [![Regulatory professional reviewing FSVP compliance documents for selling food products on Amazon USA](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/FSVP-compliance-Amazon-300x157.jpg)](https://qualitysmartsolutions.com/blog/what-amazon-usa-sellers-need-to-know-about-fsvp-compliance/) [What Amazon USA Sellers Need to Know About FSVP Compliance](https://qualitysmartsolutions.com/blog/what-amazon-usa-sellers-need-to-know-about-fsvp-compliance/) [![Health Canada cost-benefit analysis survey on natural health product red tape reduction](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/NHP-red-tape-reduction-survey-300x157.jpg)](https://qualitysmartsolutions.com/news/health-canada-launches-cost-benefit-analysis-survey-on-natural-health-product-red-tape-reduction/) [Health Canada Launches Cost-Benefit Analysis Survey on Natural Health Product Red Tape Reduction](https://qualitysmartsolutions.com/news/health-canada-launches-cost-benefit-analysis-survey-on-natural-health-product-red-tape-reduction/) [![Laser hair removal device undergoing Health Canada compliance review on a clinical table](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/laser-hair-removal-device-300x157.jpg)](https://qualitysmartsolutions.com/blog/laser-hair-removal-device-a-guide-to-health-canada-compliance-requirements/) [Laser Hair Removal Device: A Guide to Health Canada Compliance Requirements](https://qualitysmartsolutions.com/blog/laser-hair-removal-device-a-guide-to-health-canada-compliance-requirements/) ###### Categories - [510k Submissions](https://qualitysmartsolutions.com/topic/medical-device-510k-submissions/) (5) - [Cannabis](https://qualitysmartsolutions.com/topic/cannabis/) (2) - [Cosmetics](https://qualitysmartsolutions.com/topic/cosmetics/) (15) - [Dietary Supplements](https://qualitysmartsolutions.com/topic/dietary-supplements/) (18) - [EFSA](https://qualitysmartsolutions.com/topic/efsa/) (1) - [FDA](https://qualitysmartsolutions.com/topic/fda/) (7) - [Food](https://qualitysmartsolutions.com/topic/food/) (6) - [Food & Beverage](https://qualitysmartsolutions.com/topic/food-beverage/) (20) - [Food Labelling](https://qualitysmartsolutions.com/topic/food-labelling/) (7) - [Food Safety](https://qualitysmartsolutions.com/topic/food-safety/) (22) - [FSMA-FSVP](https://qualitysmartsolutions.com/topic/fsma-fsvp/) (5) - [FSVP Importer](https://qualitysmartsolutions.com/topic/fsvp-importer/) (4) - [GRAS](https://qualitysmartsolutions.com/topic/gras/) (7) - [HACCP](https://qualitysmartsolutions.com/topic/haccp/) (4) - 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[Regulatory Update](https://qualitysmartsolutions.com/topic/regulatory-update/) (1) - [SaMD Software as a Medical Device](https://qualitysmartsolutions.com/topic/samd-software-as-a-medical-device/) (4) - [Veterinary Health Products (VHP)](https://qualitysmartsolutions.com/topic/veterinary-health-products-vhp/) (5) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Safe Food Licence Help ![](https://qualitysmartsolutions.com/wp-content/uploads/2021/01/logo.webp) # Importing Food into Canada? Don't Get Stuck at the Border As of February 12, 2024, a **mandatory Safe Food for Canadians (SFC) Licence** is required for ALL food importers. **Missing this could CRIPPLE your business**. Don’t let confusing regulations and paperwork stop your food imports. Quality Smart Solutions is your one-stop shop for a **hassle-free SFC Licence!** ✅ ![](https://qualitysmartsolutions.com/wp-content/uploads/2023/11/maxresdefault-1.jpg) 20+ Years of Experience 2000+ Clients Served 130,000+ Services Completed 5 Star Google Reviews ![352](https://qualitysmartsolutions.com/wp-content/uploads/elementor/thumbs/352-r9zxa87ophb7bvz820vy3j79nlt34cc3v8zomp5p4g.jpg) ## Sell Your Products on Amazon Canada with North America's \#1 Regulatory Solutions Provider Amazon Canada is the fastest-growing e-commerce market in North America. Many U.S.-based businesses are struggling to capitalize on this massive untapped market due to regulatory hurdles. We can help! Our team of experts are well-versed in the Canadian regulatory framework, and we can work together with you to ensure your products are compliant with Canadian requirements. ## Here's How We Can Help - **Fast-Track Your Application:** Our experts will get your SFC Licence approved ASAP! - **Avoid Costly Delays:** We handle everything, so you can focus on growing your business! - **Zero-Error Guarantee:** Say goodbye to application mistakes and frustrating rejections! - **Peace of Mind, Delivered:** Sleep soundly knowing your imports comply with Canadian regulations! ## We’re Your Safe Food for Canadians Licence Experts Fast and Easy Our team of ex-regulatory officials gets your SFC Licence approved faster than going it alone. Compliance Champions Breathe easy, we ensure your application is flawless, avoiding costly delays and fines. Industry Insiders Our decades of experience navigating complex regulations give you a compliance edge Global Growth Partners Don't stop at Canada! We offer regulatory solutions to help you comply and thrive worldwide. ## Proudly Partnered with 2000+ Brands Globally ![](https://qualitysmartsolutions.com/wp-content/uploads/2024/04/plant-fuel-nutrition-logo.webp) ![](https://qualitysmartsolutions.com/wp-content/uploads/2024/04/Inner-Armour-Logo-139602-e1686598693898.webp) ![](https://qualitysmartsolutions.com/wp-content/uploads/2024/04/Enzymedicalogo_600x180.webp) ![](https://qualitysmartsolutions.com/wp-content/uploads/2024/04/BANG-Rainbow-Unicorn-Logo.webp) ![](https://qualitysmartsolutions.com/wp-content/uploads/2024/04/Hydralyte.webp) ![](https://qualitysmartsolutions.com/wp-content/uploads/2024/04/Buddha_Teas_logo-1.webp) ![](https://qualitysmartsolutions.com/wp-content/uploads/2024/04/Humm-Logo.webp) ![](https://qualitysmartsolutions.com/wp-content/uploads/2024/04/Jamieson-logo.webp) ![](https://qualitysmartsolutions.com/wp-content/uploads/2024/04/pending-1687195640-Unilever.webp) ![](https://qualitysmartsolutions.com/wp-content/uploads/2024/04/Bio-Steel-Logo.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/neocell.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2024/04/AG_Brand_Logo_Logo.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2024/04/optimumnutrition.webp) ![](https://qualitysmartsolutions.com/wp-content/uploads/2024/04/smarty-pants-vitamins.webp) ![](https://qualitysmartsolutions.com/wp-content/uploads/2024/04/vital-proteins-logo.webp) ![](https://qualitysmartsolutions.com/wp-content/uploads/2024/04/Nestle-Logo.webp) ![](https://qualitysmartsolutions.com/wp-content/uploads/2024/04/VitaCup__Logo.webp) Our Presence - 260 PeachTree Street Northwest Suite 2200, Atlanta, Georgia, 30303, USA - 4145 North Service Rd. #212 Burlington Ontario, L7L 6A3 Canada We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. 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[Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Generally Recognized as Safe [Skip to content](https://qualitysmartsolutions.com/press-release/generally-recognized-as-safe-gras#content) # Generally Recognized as Safe (GRAS) ![](https://qualitysmartsolutions.com/wp-content/uploads/2023/08/Notified-GlobeNewswire-Color-Small.webp) \[gnw url= “https://rss.globenewswire.com/WpFeed/Language/EN/search/Generally%20Recognized%20as%20Safe/io/false/subex/cla/Content/photo/Max/10/timezone/Eastern Standard Time/dateFormat/MMM dd yyyy hh:mm” article=”inline”\] [PrevMedical Equipment](https://qualitysmartsolutions.com/press-release/medical-equipment/) [FDA MoCRA Cosmetics Direct Portal Now OpenNext](https://qualitysmartsolutions.com/press-release/fda-mocra-cosmetics-direct-portal-now-open/) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Medical Equipment News [Skip to content](https://qualitysmartsolutions.com/press-release/medical-equipment#content) # Medical Equipment ![](https://qualitysmartsolutions.com/wp-content/uploads/2023/08/Notified-GlobeNewswire-Color-Small.webp) \[gnw url= “https://rss.globenewswire.com/WpFeed/Language/EN/Industry/4535/Industry/4537/Content/photo/Max/10/timezone/Eastern Standard Time/dateFormat/MMM dd yyyy hh:mm” article=”inline”\] [PrevClinical Trials](https://qualitysmartsolutions.com/press-release/clinical-trials/) [Generally Recognized as Safe (GRAS)Next](https://qualitysmartsolutions.com/press-release/generally-recognized-as-safe-gras/) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Clinical Trials Overview [Skip to content](https://qualitysmartsolutions.com/press-release/clinical-trials#content) # Clinical Trials ![](https://qualitysmartsolutions.com/wp-content/uploads/2023/08/Notified-GlobeNewswire-Color-Small.webp) \[gnw url=”https://rss.globenewswire.com/WpFeed/Language/EN/search/clinical%20trial/io/false/subex/cla/Content/photo/Max/10/timezone/Eastern Standard Time/dateFormat/MMM dd yyyy hh:mm” article=”inline”\] [Medical EquipmentNext](https://qualitysmartsolutions.com/press-release/medical-equipment/) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## MoCRA Cosmetics Portal [Skip to content](https://qualitysmartsolutions.com/press-release/fda-mocra-cosmetics-direct-portal-now-open#content) # FDA MoCRA Cosmetics Direct Portal Now Open \[Georgia, USA – Dec 19, 2023\] – As the deadline for electronic registration under the Modernization of Cosmetics Regulation Act (MoCRA) approaches, numerous cosmetic companies brace themselves for the shift towards digital compliance. Quality Smart Solutions, a prominent FDA regulatory compliance solutions provider with substantial expertise in the cosmetics domain, is primed to assist manufacturers through this pivotal transition. With the FDA’s Cosmetics Direct portal now open, the process of electronic registration and listing may appear complex. However, Quality Smart Solutions pledges to streamline this journey. Leveraging over two decades of experience aiding more than 2,000 clients spanning diverse industries, we grasp the distinct hurdles encountered by cosmetic manufacturers. **A** **lthough the statutory cut-off for facility registration and product listing remains December 29, 2023, the FDA has extended enforcement discretion until July 1, 2024, allowing a six-month extension.** **It is imperative to note that this extension solely pertains to facility registration and product listing. All other statutory obligations effective from December 29, 2023, will be rigorously enforced, encompassing adverse event monitoring and reporting, safety validation, professional use labeling, records accessibility, among others.** “We provide a comprehensive array of services tailored specifically for the cosmetic industry,” remarked Andrew Parshad, CEO of Quality Smart Solutions. “From MoCRA compliance assessments and data preparation to expert training and continuous support, our aim is to facilitate a seamless transition to the new electronic system.” **Our adept team stands prepared to assist in every facet of the process, including:** - Identification of potential gaps and ensuring a smooth transition to the Cosmetics Direct portal - Accurate registration of cosmetic facilities with the FDA - U.S. Agent representation for cosmetic facilities located outside the U.S. - Aid in submitting and managing cosmetic product listings - Collection and reporting of adverse events - Detailed reviews of cosmetic labeling and ingredients - Provision of formulation software, online training, and ongoing support For additional details and comprehensive information on MoCRA compliance and cosmetic regulation, visit our website at [https://qualitysmartsolutions.com/mocra-cosmetic-regulation/](https://qualitysmartsolutions.com/mocra-cosmetic-regulation/ "https://qualitysmartsolutions.com/mocra-cosmetic-regulation/"). **Should any inquiries about FDA requirements or regulatory guidance arise, please reach out to Quality Smart Solutions at info@qualitysmartsolutions.com or via our Toll-Free number 1-800-396-5144.** [PrevGenerally Recognized as Safe (GRAS)](https://qualitysmartsolutions.com/press-release/generally-recognized-as-safe-gras/) [SFC (Safe Food for Canadians) Licence Requirement for Food ImportersNext](https://qualitysmartsolutions.com/press-release/sfc-safe-food-for-canadians-licence-requirement-for-food-importers/) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## FDA MoCRA Compliance Tools [Skip to content](https://qualitysmartsolutions.com/press-release/fda-releases-new-tools-for-mocra-compliance-amid-regulatory-changes#content) # FDA Releases New Tools for MoCRA Compliance Amid Regulatory Changes In a recent update, the U.S. Food and Drug Administration (FDA) has introduced key tools to streamline the process of cosmetic product facility registration and listing, aligning with the mandates of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). ### What’s New? - SPL Xforms: The FDA has released a new tool, SPL Xforms, for electronically submitting cosmetic product facility registrations and product listings. While electronic submission isn’t mandatory, it’s strongly encouraged. - Paper Forms Available: Prefer the traditional route? No problem! Form FDA 5066 and 5067 offer a paper submission option. ### Staying Compliant: - Register your facilities: Although an extension is granted, but all cosmetic manufacturers and processors were supposed to register their facilities with the FDA by December 29, 2023. ### Your Action Plan: - Review the Updated FDA Guidance: Familiarize yourself with the latest requirements and procedures. - Choose Your Submission Method: Weigh the pros and cons of electronic tools like SPL Xforms versus paper forms. - Seek Expert Support: Consider partnering with experienced consultants for a stress-free compliance journey. ### Why Act Now? - Avoid the rush: Leaving things to the last minute can lead to errors, delays, and potential FDA penalties. - Gain a head start: Early compliance opens doors to valuable insights and potential adjustments before the deadline. - Peace of mind: A proactive approach to MoCRA ensures your business operates seamlessly amidst the new regulations. ### Register with FDA today - Register your facility - List your cosmetic products - Designate a U.S. Agent for FDA communications - Report serious adverse events We understand the intricacies of MoCRA and its requirements, guiding you through every step of the registration and listing process. Contact us today at [info@qualitysmartsolutions.com](mailto:info@qualitysmartsolutions.com) to get FDA MoCRA compliant. Quality Smart Solutions have served over 2000 brands for last two decades and have a distinct expertise to minimize your compliance risk in ever evolving regulatory landscape and ensuring your business operates smoothly and confidently. [PrevSFC (Safe Food for Canadians) Licence Requirement for Food Importers](https://qualitysmartsolutions.com/press-release/sfc-safe-food-for-canadians-licence-requirement-for-food-importers/) [Health Canada Proposes Expedited Approval for NMN, Enhancing Access to Natural Health ProductsNext](https://qualitysmartsolutions.com/press-release/health-canada-proposes-expedited-approval-for-nmn-enhancing-access-to-natural-health-products/) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## NMN Approval Acceleration [Skip to content](https://qualitysmartsolutions.com/press-release/health-canada-proposes-expedited-approval-for-nmn-enhancing-access-to-natural-health-products#content) # Health Canada Proposes Expedited Approval for NMN, Enhancing Access to Natural Health Products Toronto, ON — In a pivotal regulatory shift, Health Canada is set to reduce the approval times for Class 3 natural health products (NHPs), including Nicotinamide Mononucleotide (NMN), from over 10 months to approximately two months. This announcement is part of a broader initiative to streamline processes while ensuring the safety and efficacy of NHPs in Canada. “This regulatory evolution marks a significant milestone for the Canadian health product landscape, promising quicker access to products like NMN while maintaining high safety standards.” Andrew Parshad, **CEO, Quality Smart Solutions.** **Understanding the Proposed Changes** **Speedier Approval Times:** Under the new regulations, the licensing process for natural health products such as NMN will be expedited from the current timeline of over ten months to approximately 60 days (about 2 months). **Global Regulatory Landscape:** This change is particularly poignant as it contrasts with recent actions taken in the U.S., where NMN has been classified as a drug, leading to its removal from dietary supplement shelves. Alongside the NMN proposal, Health Canada also updates regulations for several other NHPs, including alfalfa, ginseng, and black pepper. These changes aim to modernize the process and ensure natural health products’ safety. **The Impact on Companies and Consumers** **Increased Access and Reduced Wait Times:** Businesses will be able to bring their services or products to market much faster, which will allow Canadian consumers quicker access to new natural health products. **Maintaining High Safety Standards:** Despite the faster process, Health Canada assures that the rigorous safety and efficacy standards currently in place will remain uncompromised. **Participation and Transparency** Health Canada is currently holding consultations on these proposals, seeking input from industry stakeholders and the public to ensure a transparent and inclusive regulatory process. Quality Smart Solutions is a leading provider of regulatory solutions in the health and wellness industry. We offer expert compliance, training, and consulting services to ensure product safety and market readiness. Over the past two decades, we have served more than 2000 brands, honing unique expertise that minimizes compliance risks in an evolving regulatory landscape and ensures smooth and confident business operations. **Stay Updated and Compliant** As the regulatory landscape continues to evolve, Quality Smart Solutions remains at the forefront, offering unparalleled expertise in navigating these changes. Contact us at [info@qualitysmartsolutions.com](mailto:info@qualitysmartsolutions.com) to ensure your products meet the latest standards and gain faster market access under Health Canada’s new guidelines. [PrevFDA Releases New Tools for MoCRA Compliance Amid Regulatory Changes](https://qualitysmartsolutions.com/press-release/fda-releases-new-tools-for-mocra-compliance-amid-regulatory-changes/) [New Cosmetic Regulation Amendments by Health Canada in 2024Next](https://qualitysmartsolutions.com/press-release/new-cosmetic-regulation-amendments-by-health-canada-in-2024/) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## New Cosmetic Regulations [Skip to content](https://qualitysmartsolutions.com/press-release/new-cosmetic-regulation-amendments-by-health-canada-in-2024#content) # New Cosmetic Regulation Amendments by Health Canada in 2024 Ottawa, Ontario—Health Canada is proud to announce significant updates to the Cosmetic Regulations under the Food and Drugs Act, designed to enhance ingredient transparency and ensure consumer safety. These amendments focus on the precise disclosure of fragrance allergens, align with international standards, and equip Canadian consumers with essential product information. This initiative underscores Health Canada’s commitment to modernizing industry practices while prioritizing consumer health. Details published in the Canada Gazette reveal that these changes are set to revolutionize the transparency of cosmetic ingredient information, positioning consumer safety and informed choices at the forefront. **Detailed Overview of Key Amendments** **Newly Implemented Measures** - Mandatory Fragrance Allergen Disclosure: Labels on cosmetic products must now list specific fragrance allergens if their concentrations exceed 0.001% in leave-on products and 0.01% in rinse-off products. This policy aims to protect consumers with allergies and sensitivities by providing them with the necessary information to make safe choices. - Digital Ingredient Listings for Small Packages: To address the constraints of label size on small packaging, ingredients can now be listed on a website linked directly from the product packaging. This ensures that consumers can access comprehensive ingredient information regardless of the product size. **Changes Made** - Clarified Definitions for Manufacturers and Importers: The regulations clarify the responsibilities and definitions related to manufacturers and importers, tightening compliance and ensuring accountability across the distribution chain. - Enhanced Cosmetic Notification Requirements: Regulations now require that any new cosmetic introduced to the Canadian market be reported to Health Canada within 10 days of the first sale. Changes to the product’s formula or market status must also be reported promptly. **Important Considerations** - Implementation in Phases: The regulations will be implemented in phases. General provisions take effect six months after registration, while fragrance allergen disclosure requirements will activate two years post-registration. - Consumer-Centric Regulations: These measures protect consumers and facilitate industry adaptation and innovation, providing a transition period and comprehensive guidance to ensure companies comply effectively. **_“As an organization specializing in regulatory compliance, we welcome these progressive measures,” remarks Andrew Parshad, CEO of Quality Smart Solutions. “This consumer-centric approach bolsters safety and facilitates innovation within the cosmetics sector. These enhanced regulations will elevate the industry, foster consumer trust, and ultimately lead to better products and informed consumer choices._** **Impact on Businesses** - Compliance Costs: Companies may face initial costs associated with revising product labels and updating marketing materials to meet new disclosure requirements. However, these costs are considered an investment towards building consumer trust and aligning with international standards. - Operational Adjustments: Manufacturers and importers must adjust their operational processes to ensure timely reporting of product information to Health Canada. This includes systems for tracking ingredient concentrations and updating product labels efficiently. - Market Opportunities: Enhanced transparency may lead to increased consumer confidence, potentially driving sales for companies that prominently display their adherence to these stringent standards. The emphasis on digital disclosures also opens opportunities for innovative marketing strategies, such as QR codes linking to detailed product information. _“These regulations mark a significant step towards enhancing the safety & transparency of cosmetic products in Canada,” stated a Health Canada spokesperson. “By aligning our standards with international norms and providing detailed guidance, we support our industry’s growth and ensure that Canadian consumers receive the highest level of protection.”_ **Need Help?** Businesses needing cosmetic compliance support can contact Health Canada regulatory experts, such as Quality Smart Solutions, at info@qualitysmartsolutions.com. Trusted by over 2,000 brands for the past two decades, Quality Smart Solutions offers expert guidance and support. [PrevHealth Canada Proposes Expedited Approval for NMN, Enhancing Access to Natural Health Products](https://qualitysmartsolutions.com/press-release/health-canada-proposes-expedited-approval-for-nmn-enhancing-access-to-natural-health-products/) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Food Import Licensing Guide [Skip to content](https://qualitysmartsolutions.com/press-release/sfc-safe-food-for-canadians-licence-requirement-for-food-importers#content) # SFC (Safe Food for Canadians) Licence Requirement for Food Importers Importing manufactured foods into Canada? Then you need a Safe Food for Canadians (SFC) licence, and **starting February 12, 2024**, things just got stricter. The Canadian Food Inspection Agency (CFIA) will now automatically verify SFC licences at the border. Without a valid license, your shipment is denied entry, leaving you facing costly delays and potential losses. But fear not! Quality Smart Solutions, your trusted partner in Canadian food importing, has served over 2,000 brands over two decades and is here to help you navigate this new landscape with ease. **Actions required before February 12th:** As applying for an SFC license can take up to 15 business days, don’t wait! Ensure you meet the following requirements: - **Step 1: Secure an SFC License:** We guide you through the application process, ensuring you acquire the right license for your product and activity. - **Step 2: Verify License Validity:** Our experts help you confirm your license is active, covers “Importing food,” and includes the specific commodities you’re importing. - **Step 3: Submit Accurate Declarations:** We assist in double-checking your import declaration and license number before submission, minimizing rejection risks. **For customs brokers:** Ask the commercial food importers you work with to provide their SFC licence number and make sure it is entered correctly on the import declaration. **For non-resident importers:** If you qualify as a non-resident importer, your SFC licence must be issued for the activity “Importing food” and for the commodities you intend to import. **Remember:** - Accuracy is key: Double-check all documentation before submitting. - Early submission is your friend: Declare your imports up to 90 days in advance to avoid border delays. Contact Quality Smart Solutions today for a free consultation on confidently importing your manufactured food products into Canada. Reach us at [**info@qualitysmartsolutions.com**](mailto:info@qualitysmartsolutions.com) or our Toll-Free number 1-800-396-5144. [PrevFDA MoCRA Cosmetics Direct Portal Now Open](https://qualitysmartsolutions.com/press-release/fda-mocra-cosmetics-direct-portal-now-open/) [FDA Releases New Tools for MoCRA Compliance Amid Regulatory ChangesNext](https://qualitysmartsolutions.com/press-release/fda-releases-new-tools-for-mocra-compliance-amid-regulatory-changes/) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Medical Device 510k Guide [Skip to content](https://qualitysmartsolutions.com/topic/medical-device-510k-submissions#content) # 510k Submissions Search Search \[searchwp\_form id=1\] \[blog\_list\] [![This article will break down the regulatory complexities of FDA 510(k) clearance, including submission requirements, classification, and more.](https://qualitysmartsolutions.com/wp-content/uploads/2023/09/QssCLE-Social-Media-Creatives-Additional-2023-09-12T141806.985-300x300.webp)](https://qualitysmartsolutions.com/blog/fda-510k-clearance-regulations/) ### [A Guide to FDA 510(k) Clearance for Medical Devices](https://qualitysmartsolutions.com/blog/fda-510k-clearance-regulations/) Navigating the intricate world of medical devices can be daunting, especially when it comes to ensuring their safety and effectiveness. ... [Read more](https://qualitysmartsolutions.com/blog/fda-510k-clearance-regulations/) October 11, 2023 [![510(k) Submission Process](https://qualitysmartsolutions.com/wp-content/uploads/2023/09/QssCLE-Social-Media-Creatives-Additional-2023-09-08T112859.627-300x300.webp)](https://qualitysmartsolutions.com/blog/medical-device-510k-submission/) ### [A Clear Guide to FDA 510(k) Submission Requirements](https://qualitysmartsolutions.com/blog/medical-device-510k-submission/) Introduction In the world of medical devices, ensuring patient safety and efficacy is paramount. The 510(k) submission process is a ... [Read more](https://qualitysmartsolutions.com/blog/medical-device-510k-submission/) September 28, 2023 [![How to prepare and submit an eStar 510k Submission as of October 1st](https://qualitysmartsolutions.com/wp-content/uploads/2023/09/QssCLE-Social-Media-Creatives-Additional-2023-09-15T111858.965-300x300.webp)](https://qualitysmartsolutions.com/news/how-to-prepare-and-submit-an-estar-510k-submission/) ### [How to prepare and submit an eStar 510k Submission as of October 1st](https://qualitysmartsolutions.com/news/how-to-prepare-and-submit-an-estar-510k-submission/) Introduction: Staying up-to-date with the latest regulations and tools is crucial in medical device submissions. As of June 9, 2023, ... [Read more](https://qualitysmartsolutions.com/news/how-to-prepare-and-submit-an-estar-510k-submission/) September 15, 2023 [![Navigating FDA Registration and the 510(k) Process: Your Guide to Getting Your Medical Device to Market](https://qualitysmartsolutions.com/wp-content/uploads/2023/08/QssCLE-Social-Media-Creatives-Additional-2023-08-30T143504.915-300x300.webp)](https://qualitysmartsolutions.com/blog/understanding-fda-510k-registration/) ### [Navigating the FDA Registration 510K Process: Your guide to getting your Medical Device to market](https://qualitysmartsolutions.com/blog/understanding-fda-510k-registration/) Introduction: So you’ve got a game-changing medical device that could reshape healthcare as we know it. Amazing! But before ... [Read more](https://qualitysmartsolutions.com/blog/understanding-fda-510k-registration/) August 30, 2023 [![510k Submissions](https://qualitysmartsolutions.com/wp-content/uploads/2023/05/QssCLE-Social-Media-Creatives-Additional-2023-05-23T152738.838-300x300.webp)](https://qualitysmartsolutions.com/blog/complete-guide-to-510k-submissions-everything-you-should-know/) ### [A complete guide to 510k submissions: Everything you should know](https://qualitysmartsolutions.com/blog/complete-guide-to-510k-submissions-everything-you-should-know/) As a medical device manufacturer, getting your product to market can be a complex process with various regulatory requirements to ... [Read more](https://qualitysmartsolutions.com/blog/complete-guide-to-510k-submissions-everything-you-should-know/) May 23, 2023 We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Cannabis Regulations Updates [Skip to content](https://qualitysmartsolutions.com/topic/cannabis#content) # Cannabis Search Search \[searchwp\_form id=1\] \[blog\_list\] [![Health Canada fees 2026 overview for medical devices drugs and cannabis](https://qualitysmartsolutions.com/wp-content/uploads/2026/01/health-canada-2026-news-300x157.jpg)](https://qualitysmartsolutions.com/news/what-you-need-to-know-about-health-canada-fees-in-2026/) ### [Health Canada Fees 2026: Updates for Devices, Drugs & Cannabis](https://qualitysmartsolutions.com/news/what-you-need-to-know-about-health-canada-fees-in-2026/) Health Canada has updated its fees effective April 1, 2026, with changes applying across multiple regulated sectors, including medical devices, ... [Read more](https://qualitysmartsolutions.com/news/what-you-need-to-know-about-health-canada-fees-in-2026/) January 6, 2026 [![](https://qualitysmartsolutions.com/wp-content/uploads/2025/03/cbd-ol-4470101_640-300x200.webp)](https://qualitysmartsolutions.com/news/health-canada-reviews-cbd-as-an-nhp-in-new-consultation/) ### [Health Canada Reviews CBD as an NHP in New Consultation](https://qualitysmartsolutions.com/news/health-canada-reviews-cbd-as-an-nhp-in-new-consultation/) Health Canada is conducting a public consultation on CBD regulations for natural health products, exploring a pathway to allow non-prescription ... [Read more](https://qualitysmartsolutions.com/news/health-canada-reviews-cbd-as-an-nhp-in-new-consultation/) March 7, 2025 We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Cosmetics Compliance Overview [Skip to content](https://qualitysmartsolutions.com/topic/cosmetics#content) # Cosmetics Search Search \[searchwp\_form id=1\] \[blog\_list\] [![Comparison chart showing traditional cosmetics and cosmeceutical](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/cosmetics-compliance-300x157.jpg)](https://qualitysmartsolutions.com/blog/traditional-cosmetics-vs-cosmeceuticals/) ### [Traditional Cosmetics vs. Cosmeceuticals: What’s the Difference?](https://qualitysmartsolutions.com/blog/traditional-cosmetics-vs-cosmeceuticals/) Understanding the distinction between traditional cosmetics vs. cosmeceuticals is essential if you’re manufacturing or marketing skincare or beauty products in ... [Read more](https://qualitysmartsolutions.com/blog/traditional-cosmetics-vs-cosmeceuticals/) May 28, 2025 [![Comparing FDA and Health Canada cosmetic compliance requirements](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/cosmetic-compliance-300x200.jpg)](https://qualitysmartsolutions.com/blog/fda-vs-health-canada-cosmetic-compliance/) ### [Comparing Cosmetic Compliance Standards: FDA and Health Canada](https://qualitysmartsolutions.com/blog/fda-vs-health-canada-cosmetic-compliance/) How FDA and Health Canada Regulate Cosmetics Differently Thinking about launching your cosmetic line in North America? Whether you’re a ... [Read more](https://qualitysmartsolutions.com/blog/fda-vs-health-canada-cosmetic-compliance/) May 1, 2025 [![FDA cosmetic regulations](https://qualitysmartsolutions.com/wp-content/uploads/2023/02/QSS-Images-2023-02-09T130115.315-300x251.webp)](https://qualitysmartsolutions.com/news/us-cosmetic-regulatory-requirements-for-manufacturers-mocra/) ### [US Cosmetic Regulatory Requirements for Manufacturers (MoCRA Regulations)](https://qualitysmartsolutions.com/news/us-cosmetic-regulatory-requirements-for-manufacturers-mocra/) https://youtu.be/uuXA8yHrrZc Introduction: Behold the “Modernization of Cosmetic Regulation Act of 2022” that President Biden signed on December 29, 2022. This ... [Read more](https://qualitysmartsolutions.com/news/us-cosmetic-regulatory-requirements-for-manufacturers-mocra/) August 9, 2023 [![cosmetics compliance](https://qualitysmartsolutions.com/wp-content/uploads/2023/08/QssCLE-Social-Media-Creatives-Additional-2023-08-08T145055.922-300x300.webp)](https://qualitysmartsolutions.com/news/registration-and-listing-of-cosmetic-product-facilities-and-products/) ### [Everything you should know about the registration and listing of Cosmetic Product Facilities and Products](https://qualitysmartsolutions.com/news/registration-and-listing-of-cosmetic-product-facilities-and-products/) This guidance provides suggestions and instructions to assist in submitting cosmetic product facility registrations and product listings to the FDA. ... [Read more](https://qualitysmartsolutions.com/news/registration-and-listing-of-cosmetic-product-facilities-and-products/) August 8, 2023 [![FDA Cosmetics Regulations](https://qualitysmartsolutions.com/wp-content/uploads/2023/07/QssCLE-Social-Media-Creatives-Additional-2023-07-06T131913.235-300x300.webp)](https://qualitysmartsolutions.com/blog/fda-cosmetics-regulations-a-cosmetics-business-step-by-step-guide/) ### [FDA Cosmetics Regulations: A cosmetics business step-by-step guide](https://qualitysmartsolutions.com/blog/fda-cosmetics-regulations-a-cosmetics-business-step-by-step-guide/) Introduction to Cosmetic Regulations by the FDA: Are you a cosmetics brand looking to navigate the complex world of FDA ... [Read more](https://qualitysmartsolutions.com/blog/fda-cosmetics-regulations-a-cosmetics-business-step-by-step-guide/) July 6, 2023 [![VCRP to prepare for the MOCRA registration](https://qualitysmartsolutions.com/wp-content/uploads/2023/04/QSS-Images-2023-04-04T141235.941-300x251.webp)](https://qualitysmartsolutions.com/news/fda-to-close-vcrp-to-prepare-for-mocra-registration/) ### [FDA to close VCRP to prepare for MOCRA registration in 2023](https://qualitysmartsolutions.com/news/fda-to-close-vcrp-to-prepare-for-mocra-registration/) Introduction: In a recent update released on March 27, 2023, the FDA announced it has stopped accepting and processing VCRP submissions to ... [Read more](https://qualitysmartsolutions.com/news/fda-to-close-vcrp-to-prepare-for-mocra-registration/) April 4, 2023 [![cosmetic labeling](https://qualitysmartsolutions.com/wp-content/uploads/2023/03/QSS-Images-2023-03-03T112427.123-300x251.webp)](https://qualitysmartsolutions.com/news/health-canada-labelling-cosmetic-notification-changes-in-2023/) ### [Health Canada Labelling & Cosmetic Notification changes in 2023](https://qualitysmartsolutions.com/news/health-canada-labelling-cosmetic-notification-changes-in-2023/) Introduction: The sections relating to the disclosure of fragrance allergens because of the regulations go into effect two years following ... [Read more](https://qualitysmartsolutions.com/news/health-canada-labelling-cosmetic-notification-changes-in-2023/) March 3, 2023 [![Cosmetic Labelling](https://qualitysmartsolutions.com/wp-content/uploads/2023/02/QssCLE-Social-Media-Creatives-Additional-54-300x300.webp)](https://qualitysmartsolutions.com/blog/everything-you-should-know-about-cosmetic-labelling/) ### [Cosmetic Labelling Rules Every Business Should Understand](https://qualitysmartsolutions.com/blog/everything-you-should-know-about-cosmetic-labelling/) Introduction: Cosmetic labelling is an essential part of developing and marketing cosmetics. Companies must meet government requirements for labelling, including ... [Read more](https://qualitysmartsolutions.com/blog/everything-you-should-know-about-cosmetic-labelling/) February 24, 2023 [![Cosmetic Notification Form (CNF)](https://qualitysmartsolutions.com/wp-content/uploads/2022/11/iStock-873899208-300x200.jpg)](https://qualitysmartsolutions.com/blog/top-canada-cosmetic-regulations-cosmetic-notification-form-cnf/) ### [How the Cosmetic Notification Form Works in Canada](https://qualitysmartsolutions.com/blog/top-canada-cosmetic-regulations-cosmetic-notification-form-cnf/) Top Canada Cosmetic Regulations Cosmetic Notification Form (CNF) Canada is one of the most popular tourist destinations in the world, ... [Read more](https://qualitysmartsolutions.com/blog/top-canada-cosmetic-regulations-cosmetic-notification-form-cnf/) November 4, 2022 [![Potentially Toxic Ingredients in Cosmetic Products](https://qualitysmartsolutions.com/wp-content/uploads/2022/05/QSS-Blog-Images-Updated-8-300x300.webp)](https://qualitysmartsolutions.com/blog/cosmetic-ingredients-potential-presence-of-toxic-substances-in-your-cosmetics/) ### [Are Toxic Substances Hiding in Your Cosmetics?](https://qualitysmartsolutions.com/blog/cosmetic-ingredients-potential-presence-of-toxic-substances-in-your-cosmetics/) What is a cosmetic? Under Section 2 of the Food and Drugs Act, a cosmetic is defined as “any substance ... [Read more](https://qualitysmartsolutions.com/blog/cosmetic-ingredients-potential-presence-of-toxic-substances-in-your-cosmetics/) May 25, 2022 [![Cosmetic Notifications](https://qualitysmartsolutions.com/wp-content/uploads/2022/02/Cosmetic-Notifications-300x193.jpg)](https://qualitysmartsolutions.com/news/your-cosmetic-notification-may-get-qualified-for-processing-in-24-hours/) ### [Your Cosmetic Notification MAY get Qualified for processing in 24 hours!](https://qualitysmartsolutions.com/news/your-cosmetic-notification-may-get-qualified-for-processing-in-24-hours/) What is a cosmetic? Under Section 2 of the Food and Drugs Act, a cosmetic is defined as “any substance ... [Read more](https://qualitysmartsolutions.com/news/your-cosmetic-notification-may-get-qualified-for-processing-in-24-hours/) February 24, 2022 [![Therapeutic Claim, Cosmetic, NHP](https://qualitysmartsolutions.com/wp-content/uploads/2022/01/Therapeutic-Claim-300x193.jpg)](https://qualitysmartsolutions.com/blog/therapeutic-claim-vs-non-therapeutic-claim-whats-the-difference-and-when-can-i-use-them/) ### [Therapeutic vs. Non-Therapeutic Claims Classification Guide](https://qualitysmartsolutions.com/blog/therapeutic-claim-vs-non-therapeutic-claim-whats-the-difference-and-when-can-i-use-them/) What is a claim? A claim is a representation for sale. It can be presented as “a word, a sentence, ... [Read more](https://qualitysmartsolutions.com/blog/therapeutic-claim-vs-non-therapeutic-claim-whats-the-difference-and-when-can-i-use-them/) January 24, 2022 [![Cosmetic Regulations](https://qualitysmartsolutions.com/wp-content/uploads/2021/12/Cosmetic-Label-300x193.jpg)](https://qualitysmartsolutions.com/blog/key-components-of-a-cosmetic-label/) ### [Top 9 Cosmetic Compliance Label Components \| Health Canada Cosmetics Regulations](https://qualitysmartsolutions.com/blog/key-components-of-a-cosmetic-label/) What is a Cosmetic? Cosmetics are a part of just about everyone’s life. Every day, most of us use products ... [Read more](https://qualitysmartsolutions.com/blog/key-components-of-a-cosmetic-label/) December 17, 2021 [![](https://qualitysmartsolutions.com/wp-content/uploads/2021/09/Cannabis-Cosmetics-300x193.jpg)](https://qualitysmartsolutions.com/news/proposal-to-amend-the-cosmetic-regulations/) ### [Proposal to Amend the Cosmetic Regulations](https://qualitysmartsolutions.com/news/proposal-to-amend-the-cosmetic-regulations/) What is a Cosmetic? Under Section 2 of the Food and Drugs Act, a cosmetic is defined as “any substance ... [Read more](https://qualitysmartsolutions.com/news/proposal-to-amend-the-cosmetic-regulations/) September 27, 2021 [![Sunscreens – Canada and U.S. Regulatory Differences](https://qualitysmartsolutions.com/wp-content/uploads/2018/07/sunscreens-canada-300x157.jpg)](https://qualitysmartsolutions.com/blog/sunscreens-canada-and-u-s-regulatory-differences/) ### [Sunscreens – Canada and U.S. Regulatory Differences](https://qualitysmartsolutions.com/blog/sunscreens-canada-and-u-s-regulatory-differences/) https://youtu.be/BEsWTYXGqAQ Summertime has finally arrived and with it comes hot temperatures and intense ultraviolet rays. Exposure to ultraviolet light is ... [Read more](https://qualitysmartsolutions.com/blog/sunscreens-canada-and-u-s-regulatory-differences/) July 11, 2018 We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Dietary Supplements Overview [Skip to content](https://qualitysmartsolutions.com/topic/dietary-supplements#content) # Dietary Supplements Search Search \[searchwp\_form id=1\] \[blog\_list\] [![FDA to revoke Red No. 3 authorization](https://qualitysmartsolutions.com/wp-content/uploads/2025/01/alexander-schimmeck-sWSJNyb6wZ8-unsplash-300x200.jpg)](https://qualitysmartsolutions.com/news/fda-to-revoke-use-of-red-no-3-what-you-need-to-know/) ### [FDA to Revoke Use of Red No. 3: What You Need to Know](https://qualitysmartsolutions.com/news/fda-to-revoke-use-of-red-no-3-what-you-need-to-know/) The FDA has just announced a significant decision: Red No. 3, a widely used synthetic dye in foods and ingested ... [Read more](https://qualitysmartsolutions.com/news/fda-to-revoke-use-of-red-no-3-what-you-need-to-know/) January 17, 2025 [![Vitafoods 2025](https://qualitysmartsolutions.com/wp-content/uploads/2025/01/event-img-300x200.jpg)](https://qualitysmartsolutions.com/events/vitafoods-india-2025/) ### [VitaFoods India 2025](https://qualitysmartsolutions.com/events/vitafoods-india-2025/) Vitafoods India 2025 is a premier event for the food, beverage, and dietary supplement industries, bringing together professionals, innovators, and ... [Read more](https://qualitysmartsolutions.com/events/vitafoods-india-2025/) January 14, 2025 [![dietary supplements in the U.S.](https://qualitysmartsolutions.com/wp-content/uploads/2023/09/jellybee-GpDSgnWFmwM-unsplash-300x146.webp)](https://qualitysmartsolutions.com/blog/requirements-to-sell-dietary-supplements-in-the-usa/) ### [10 Steps to Sell Dietary Supplements in the U.S.](https://qualitysmartsolutions.com/blog/requirements-to-sell-dietary-supplements-in-the-usa/) The dietary supplement industry in the U.S. is growing fast. More people are looking for vitamins, minerals, and other supplements ... [Read more](https://qualitysmartsolutions.com/blog/requirements-to-sell-dietary-supplements-in-the-usa/) September 14, 2023 [![import NMN supplements to Canada](https://qualitysmartsolutions.com/wp-content/uploads/2023/06/QssCLE-Social-Media-Creatives-Additional-2023-06-01T162408.583-300x300.webp)](https://qualitysmartsolutions.com/blog/how-can-businesses-import-their-nmn-supplements-to-canada/) ### [A Business Guide to Importing NMN Supplements Into Canada](https://qualitysmartsolutions.com/blog/how-can-businesses-import-their-nmn-supplements-to-canada/) As more and more people become health-conscious, the demand for supplements has skyrocketed. One of the most popular supplements on ... [Read more](https://qualitysmartsolutions.com/blog/how-can-businesses-import-their-nmn-supplements-to-canada/) June 2, 2023 [![substantiation reports dossiers FTC regulations](https://qualitysmartsolutions.com/wp-content/uploads/2023/04/QssCLE-Social-Media-Creatives-Additional-2023-04-21T122113.204-300x300.webp)](https://qualitysmartsolutions.com/news/ftc-puts-nearly-700-companies-on-notice-of-product-claim-civil-penalties/) ### [FTC puts nearly 700 companies on notice of product claim civil penalties](https://qualitysmartsolutions.com/news/ftc-puts-nearly-700-companies-on-notice-of-product-claim-civil-penalties/) Introduction: On April 13th, the Federal Trade Commission sent letters to warn hundreds of marketers to refrain from misleading customers with product ... [Read more](https://qualitysmartsolutions.com/news/ftc-puts-nearly-700-companies-on-notice-of-product-claim-civil-penalties/) April 21, 2023 [![FDA Regulatory Framework of Dietary Supplements](https://qualitysmartsolutions.com/wp-content/uploads/2023/04/QssCLE-Social-Media-Creatives-Additional-2023-04-03T151219.979-300x300.webp)](https://qualitysmartsolutions.com/blog/understanding-the-regulatory-framework-of-dietary-supplements/) ### [A Guide to Dietary Supplement Regulations](https://qualitysmartsolutions.com/blog/understanding-the-regulatory-framework-of-dietary-supplements/) Navigating the complexities of the regulatory requirements for dietary supplements can be daunting. However, by understanding the framework, you can ... [Read more](https://qualitysmartsolutions.com/blog/understanding-the-regulatory-framework-of-dietary-supplements/) April 4, 2023 [![FDA Dietary Supplements Labeling Requirements in the USA](https://qualitysmartsolutions.com/wp-content/uploads/2023/01/QSS-Images-45-300x251.webp)](https://qualitysmartsolutions.com/blog/fda-dietary-supplements-labeling-requirements-in-the-usa/) ### [A Practical Guide to Dietary Supplement Labelling Requirements](https://qualitysmartsolutions.com/blog/fda-dietary-supplements-labeling-requirements-in-the-usa/) Introduction: The FDA offers an online dietary supplement labeling guide that provides labeling requirements for supplement manufacturers. The guide covers ... [Read more](https://qualitysmartsolutions.com/blog/fda-dietary-supplements-labeling-requirements-in-the-usa/) January 11, 2023 [![](https://qualitysmartsolutions.com/wp-content/uploads/2021/11/nac-warning-300x193.jpg)](https://qualitysmartsolutions.com/blog/fda-warning-letters-targeting-n-acetyl-cysteine-nac-supplements/) ### [FDA NAC Warning Letter: Targeting N-Acetyl Cysteine (NAC) Supplements](https://qualitysmartsolutions.com/blog/fda-warning-letters-targeting-n-acetyl-cysteine-nac-supplements/) Background on FDA NAC Warning Letters: Navigating the FDA’s NAC system can be overwhelming. Understanding FDA warning letters is key ... [Read more](https://qualitysmartsolutions.com/blog/fda-warning-letters-targeting-n-acetyl-cysteine-nac-supplements/) November 2, 2022 [![FDA GRAS](https://qualitysmartsolutions.com/wp-content/uploads/2021/09/tabs-1-300x193.jpg)](https://qualitysmartsolutions.com/blog/gras-generally-recognized-as-safe-new-dietary-ingredient-ndin/) ### [GRAS Consultants: NDIN or FDA GRAS Certification?](https://qualitysmartsolutions.com/blog/gras-generally-recognized-as-safe-new-dietary-ingredient-ndin/) Say you have a new ingredient and are ready to enter the US food market. To ensure this ingredient is ... [Read more](https://qualitysmartsolutions.com/blog/gras-generally-recognized-as-safe-new-dietary-ingredient-ndin/) October 28, 2022 [![NAC Products Dietary Supplements](https://qualitysmartsolutions.com/wp-content/uploads/2022/08/CLEQSS-Blog-Images-1-300x300.webp)](https://qualitysmartsolutions.com/news/nac-products-fda-releases-draft-guidance-on-enforcement-discretion/) ### [FDA Releases Draft Guidance on Enforcement Discretion for Certain NAC Products](https://qualitysmartsolutions.com/news/nac-products-fda-releases-draft-guidance-on-enforcement-discretion/) Navigating the FDA and NAC regulations can be intimidating, but with the right information and guidance, you’ll be able to ... [Read more](https://qualitysmartsolutions.com/news/nac-products-fda-releases-draft-guidance-on-enforcement-discretion/) August 4, 2022 [![NHP Labelling](https://qualitysmartsolutions.com/wp-content/uploads/2022/04/dietary-supplements-300x193.jpg)](https://qualitysmartsolutions.com/blog/dietary-supplement-labeling-vs-nhp-labeling-in-north-america/) ### [Learn how to differentiate Dietary Supplement vs NHP Labeling](https://qualitysmartsolutions.com/blog/dietary-supplement-labeling-vs-nhp-labeling-in-north-america/) Introduction Dietary supplements in the USA are very similar to natural health products (NHP regulations) in Canada and many products ... [Read more](https://qualitysmartsolutions.com/blog/dietary-supplement-labeling-vs-nhp-labeling-in-north-america/) April 18, 2022 [![](https://qualitysmartsolutions.com/wp-content/uploads/2022/02/high-blood-pressure-300x193.jpg)](https://qualitysmartsolutions.com/news/fda-announces-qualified-health-claim-for-magnesium-and-reduced-risk-of-high-blood-pressure/) ### [FDA Qualified Health Claim for Magnesium 2022](https://qualitysmartsolutions.com/news/fda-announces-qualified-health-claim-for-magnesium-and-reduced-risk-of-high-blood-pressure/) The U.S. Food and Drug Administration (FDA) has communicated via Letter of Enforcement Discretion that it will not oppose or ... [Read more](https://qualitysmartsolutions.com/news/fda-announces-qualified-health-claim-for-magnesium-and-reduced-risk-of-high-blood-pressure/) February 3, 2022 [![](https://qualitysmartsolutions.com/wp-content/uploads/2022/01/supplement-facts-300x193.jpg)](https://qualitysmartsolutions.com/news/fda-requests-information-relevant-to-the-use-of-nac-as-a-dietary-supplement/) ### [FDA Requests Relevant Info to use NAC as a Dietary Supplement](https://qualitysmartsolutions.com/news/fda-requests-information-relevant-to-the-use-of-nac-as-a-dietary-supplement/) On November 24, 2021, The Food and Drug Administration (FDA) sent correspondence to industry requesting information on the past use ... [Read more](https://qualitysmartsolutions.com/news/fda-requests-information-relevant-to-the-use-of-nac-as-a-dietary-supplement/) January 4, 2022 [![](https://qualitysmartsolutions.com/wp-content/uploads/2021/12/fda_sodium-300x193.jpg)](https://qualitysmartsolutions.com/news/fda-issues-sodium-reduction-final-guidance/) ### [FDA Issues Sodium Reduction Final Guidance](https://qualitysmartsolutions.com/news/fda-issues-sodium-reduction-final-guidance/) On October 13, 2021, the U.S. Food and Drug Administration (FDA) issued final guidance for the food industry that provides ... [Read more](https://qualitysmartsolutions.com/news/fda-issues-sodium-reduction-final-guidance/) December 4, 2021 [![](https://qualitysmartsolutions.com/wp-content/uploads/2021/08/animal-supplements-300x193.jpg)](https://qualitysmartsolutions.com/blog/animal-supplements-in-the-usa/) ### [Animal Supplements in the USA](https://qualitysmartsolutions.com/blog/animal-supplements-in-the-usa/) Animal Supplements in the USA – What You Need to Know How are animal supplements regulated in the USA? Dietary ... [Read more](https://qualitysmartsolutions.com/blog/animal-supplements-in-the-usa/) August 2, 2021 [![](https://qualitysmartsolutions.com/wp-content/uploads/2021/07/supplemented-products-300x204.jpg)](https://qualitysmartsolutions.com/news/supplemented-foods-proposed-regulatory-framework/) ### [Supplemented Foods Proposed Regulatory Framework](https://qualitysmartsolutions.com/news/supplemented-foods-proposed-regulatory-framework/) Health Canada has been working on creating/revising the regulations with regards to Supplemented Foods for some time now. A recent ... [Read more](https://qualitysmartsolutions.com/news/supplemented-foods-proposed-regulatory-framework/) July 24, 2021 [![](https://qualitysmartsolutions.com/wp-content/uploads/2021/09/dietary-supplements-amazon-300x193.jpg)](https://qualitysmartsolutions.com/blog/how-to-sell-a-dietary-supplement-nhp-on-amazon-ca-or-online-in-canada/) ### [How to sell a Dietary Supplement NHP on Amazon.ca (or online in Canada)](https://qualitysmartsolutions.com/blog/how-to-sell-a-dietary-supplement-nhp-on-amazon-ca-or-online-in-canada/) How to Sell Dietary Supplements or NHPs on Amazon or Other Online Platforms in Canada? What is an NHP? In ... [Read more](https://qualitysmartsolutions.com/blog/how-to-sell-a-dietary-supplement-nhp-on-amazon-ca-or-online-in-canada/) July 13, 2021 [![](https://qualitysmartsolutions.com/wp-content/uploads/2021/01/Slide-1-Latest-NHP-news-300x300.jpg)](https://qualitysmartsolutions.com/blog/top-3-things-to-consider-when-planning-to-sell-your-dietary-supplement-in-canada/) ### [Top 3 things to consider when planning to sell your Dietary Supplement in CANADA](https://qualitysmartsolutions.com/blog/top-3-things-to-consider-when-planning-to-sell-your-dietary-supplement-in-canada/) Some companies make the assumption that selling a dietary supplement product in Canada is no different than selling in the ... [Read more](https://qualitysmartsolutions.com/blog/top-3-things-to-consider-when-planning-to-sell-your-dietary-supplement-in-canada/) February 9, 2015 We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## EFSA Updates on Food Safety [Skip to content](https://qualitysmartsolutions.com/topic/efsa#content) # EFSA Search Search \[searchwp\_form id=1\] \[blog\_list\] [![EFSA 2025 QPS Update - New Microorganisms for Food Safety](https://qualitysmartsolutions.com/wp-content/uploads/2025/01/efsa-food-safety-300x200.jpg)](https://qualitysmartsolutions.com/news/efsa-qps-update-new-microorganisms-for-food-safety/) ### [What’s New in the EFSA QPS Update for Food Safety?](https://qualitysmartsolutions.com/news/efsa-qps-update-new-microorganisms-for-food-safety/) The EFSA QPS update is here, and it brings important changes for businesses involved in food and feed safety. As ... [Read more](https://qualitysmartsolutions.com/news/efsa-qps-update-new-microorganisms-for-food-safety/) January 22, 2025 We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## FDA Regulatory Insights [Skip to content](https://qualitysmartsolutions.com/topic/fda#content) # FDA Search Search \[searchwp\_form id=1\] \[blog\_list\] [![FDA OMUFA FY 2025 fee deadline for OTC manufacturers](https://qualitysmartsolutions.com/wp-content/uploads/2025/06/OTC-drug-facility-fee-300x168.jpg)](https://qualitysmartsolutions.com/blog/fy-2025-omufa-fees-due-june-2-what-you-need-to-know/) ### [FY 2025 OMUFA Fees Due June 2: What You Need to Know](https://qualitysmartsolutions.com/blog/fy-2025-omufa-fees-due-june-2-what-you-need-to-know/) The FDA has confirmed that FY 2025 OMUFA facility fees are due soon. If your business was registered as a ... [Read more](https://qualitysmartsolutions.com/blog/fy-2025-omufa-fees-due-june-2-what-you-need-to-know/) June 1, 2025 [![FDA to revoke Red No. 3 authorization](https://qualitysmartsolutions.com/wp-content/uploads/2025/01/alexander-schimmeck-sWSJNyb6wZ8-unsplash-300x200.jpg)](https://qualitysmartsolutions.com/news/fda-to-revoke-use-of-red-no-3-what-you-need-to-know/) ### [FDA to Revoke Use of Red No. 3: What You Need to Know](https://qualitysmartsolutions.com/news/fda-to-revoke-use-of-red-no-3-what-you-need-to-know/) The FDA has just announced a significant decision: Red No. 3, a widely used synthetic dye in foods and ingested ... [Read more](https://qualitysmartsolutions.com/news/fda-to-revoke-use-of-red-no-3-what-you-need-to-know/) January 17, 2025 [![FDA front-of-package nutrition labeling proposed rule.](https://qualitysmartsolutions.com/wp-content/uploads/2025/01/food-labelling-process-300x200.jpg)](https://qualitysmartsolutions.com/news/whats-behind-the-fdas-new-front-of-package-labeling-proposal/) ### [What’s Behind the FDA’s New Front-of-Package Labeling Proposal?](https://qualitysmartsolutions.com/news/whats-behind-the-fdas-new-front-of-package-labeling-proposal/) The FDA’s proposed front-of-package (FOP) nutrition labeling rule introduces significant changes to how nutritional information is displayed. This proposal reflects ... [Read more](https://qualitysmartsolutions.com/news/whats-behind-the-fdas-new-front-of-package-labeling-proposal/) January 16, 2025 [![US FDA AGENTS](https://qualitysmartsolutions.com/wp-content/uploads/2023/06/QssCLE-Social-Media-Creatives-Additional-2023-06-28T120443.472-300x300.webp)](https://qualitysmartsolutions.com/blog/us-fda-agents-safeguarding-public-health-and-drug-safety/) ### [The Role of FDA Agents in U.S. Compliance](https://qualitysmartsolutions.com/blog/us-fda-agents-safeguarding-public-health-and-drug-safety/) In a world where the pharmaceutical industry is constantly evolving and new drugs are being introduced to the market every ... [Read more](https://qualitysmartsolutions.com/blog/us-fda-agents-safeguarding-public-health-and-drug-safety/) June 28, 2023 [![FDA fees](https://qualitysmartsolutions.com/wp-content/uploads/2023/06/QssCLE-Social-Media-Creatives-Additional-2023-06-16T162152.350-300x300.webp)](https://qualitysmartsolutions.com/blog/navigating-fda-fees-how-to-budget-and-plan-for-regulatory-costs/) ### [Managing FDA Fees: Budgeting and Planning for Success](https://qualitysmartsolutions.com/blog/navigating-fda-fees-how-to-budget-and-plan-for-regulatory-costs/) Are you a company in the healthcare or pharmaceutical industry looking to bring a new product to market? If so, ... [Read more](https://qualitysmartsolutions.com/blog/navigating-fda-fees-how-to-budget-and-plan-for-regulatory-costs/) June 16, 2023 [![FDA Medical Device MDUFA Fees in 2023](https://qualitysmartsolutions.com/wp-content/uploads/2022/11/MDUFA-Fees-300x133.webp)](https://qualitysmartsolutions.com/news/fda-inside-scoop-medical-device-user-fees-mdufa-for-2023/) ### [Inside Scoop FDA Medical Device User Fees (MDUFA) for 2023](https://qualitysmartsolutions.com/news/fda-inside-scoop-medical-device-user-fees-mdufa-for-2023/) The FDA or U.S. Food and Drug Administration recently announced the Fiscal Year Medical Device User Fee (MDUFA) amendments. The ... [Read more](https://qualitysmartsolutions.com/news/fda-inside-scoop-medical-device-user-fees-mdufa-for-2023/) November 1, 2022 [![NAC Products Dietary Supplements](https://qualitysmartsolutions.com/wp-content/uploads/2022/08/CLEQSS-Blog-Images-1-300x300.webp)](https://qualitysmartsolutions.com/news/nac-products-fda-releases-draft-guidance-on-enforcement-discretion/) ### [FDA Releases Draft Guidance on Enforcement Discretion for Certain NAC Products](https://qualitysmartsolutions.com/news/nac-products-fda-releases-draft-guidance-on-enforcement-discretion/) Navigating the FDA and NAC regulations can be intimidating, but with the right information and guidance, you’ll be able to ... [Read more](https://qualitysmartsolutions.com/news/nac-products-fda-releases-draft-guidance-on-enforcement-discretion/) August 4, 2022 We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Food Insights and Trends [Skip to content](https://qualitysmartsolutions.com/topic/food#content) # Food Search Search \[searchwp\_form id=1\] \[blog\_list\] [![](https://qualitysmartsolutions.com/wp-content/uploads/2025/02/naturalproductsexpowest-rgb.webp)](https://qualitysmartsolutions.com/events/natural-products-expo-west-2025/) ### [Natural Products Expo West 2025](https://qualitysmartsolutions.com/events/natural-products-expo-west-2025/) Join Quality Smart Solutions at Natural Products Expo West 2025, the top trade show for the natural, organic, and healthy ... [Read more](https://qualitysmartsolutions.com/events/natural-products-expo-west-2025/) February 7, 2025 [![HACCP](https://qualitysmartsolutions.com/wp-content/uploads/2022/05/haccp-plan-300x193.jpg)](https://qualitysmartsolutions.com/blog/hazard-analysis-critical-control-point-haccp-plan-7-principles/) ### [7 Principles of HACCP: Everything you need to know before building a HACCP plan](https://qualitysmartsolutions.com/blog/hazard-analysis-critical-control-point-haccp-plan-7-principles/) What is HACCP? A common question that comes up in regulated industries, such as food manufacturing and processing, is “What ... [Read more](https://qualitysmartsolutions.com/blog/hazard-analysis-critical-control-point-haccp-plan-7-principles/) May 12, 2022 [![](https://qualitysmartsolutions.com/wp-content/uploads/2022/03/vitamin-d-food-300x193.jpg)](https://qualitysmartsolutions.com/news/health-canada-marketing-authorization-update-increased-vitamin-d/) ### [Health Canada Marketing Authorization Update – Increased Vitamin D](https://qualitysmartsolutions.com/news/health-canada-marketing-authorization-update-increased-vitamin-d/) On January 19, 2022, Health Canada announced a marketing authorization (MA) to permit manufacturers to voluntarily increase the amount of ... [Read more](https://qualitysmartsolutions.com/news/health-canada-marketing-authorization-update-increased-vitamin-d/) March 22, 2022 [![](https://qualitysmartsolutions.com/wp-content/uploads/2022/02/high-blood-pressure-300x193.jpg)](https://qualitysmartsolutions.com/news/fda-announces-qualified-health-claim-for-magnesium-and-reduced-risk-of-high-blood-pressure/) ### [FDA Qualified Health Claim for Magnesium 2022](https://qualitysmartsolutions.com/news/fda-announces-qualified-health-claim-for-magnesium-and-reduced-risk-of-high-blood-pressure/) The U.S. Food and Drug Administration (FDA) has communicated via Letter of Enforcement Discretion that it will not oppose or ... [Read more](https://qualitysmartsolutions.com/news/fda-announces-qualified-health-claim-for-magnesium-and-reduced-risk-of-high-blood-pressure/) February 3, 2022 [![NPN, Ingredient Database](https://qualitysmartsolutions.com/wp-content/uploads/2021/12/greens-and-protein-products-300x193.jpg)](https://qualitysmartsolutions.com/blog/greens-and-proteins-food-or-nhp/) ### [Greens and Proteins – Food or NHP?](https://qualitysmartsolutions.com/blog/greens-and-proteins-food-or-nhp/) The classification of Foods and Natural Health Products (NHPs) can be considered difficult, grey, and convoluted. Sometimes even comes down ... [Read more](https://qualitysmartsolutions.com/blog/greens-and-proteins-food-or-nhp/) December 14, 2021 [![](https://qualitysmartsolutions.com/wp-content/uploads/2021/11/pet-foods-300x193.jpg)](https://qualitysmartsolutions.com/blog/how-pet-food-labels-differ-from-human-foods/) ### [How Pet Food VHP Labels Differ from Human Food Labels in 2022](https://qualitysmartsolutions.com/blog/how-pet-food-labels-differ-from-human-foods/) Pet Foods and Human Food Labels are designed to look similar yet distinct. There are some similar label requirements and ... [Read more](https://qualitysmartsolutions.com/blog/how-pet-food-labels-differ-from-human-foods/) November 8, 2021 We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Food & Beverage Regulations [Skip to content](https://qualitysmartsolutions.com/topic/food-beverage#content) # Food & Beverage Search Search \[searchwp\_form id=1\] \[blog\_list\] [![This article will explore what it takes to sell food in Canada, from staple products to those with added supplements.](https://qualitysmartsolutions.com/wp-content/uploads/2023/09/QssCLE-Social-Media-Creatives-Additional-2023-09-13T163407.375-300x300.webp)](https://qualitysmartsolutions.com/blog/requirements-to-sell-food-in-canada/) ### [Selling Food in Canada: Navigating the Requirements for Conventional and Supplemented Products](https://qualitysmartsolutions.com/blog/requirements-to-sell-food-in-canada/) https://youtu.be/QABD-2XIRz0 Canada is known for its diverse culinary landscape. If you’re considering selling food products in this country, you’re in ... [Read more](https://qualitysmartsolutions.com/blog/requirements-to-sell-food-in-canada/) October 12, 2023 ### [New CFIA regulatory responsibilities regarding caffeinated energy drinks](https://qualitysmartsolutions.com/news/cfia-regulatory-responsibilities-regarding-caffeinated-drinks/) The Canadian Food Inspection Agency (CFIA) has regulated food products for many years, with a particular focus on the safety ... [Read more](https://qualitysmartsolutions.com/news/cfia-regulatory-responsibilities-regarding-caffeinated-drinks/) August 18, 2023 [![FDA Facility Renewal and Registration](https://qualitysmartsolutions.com/wp-content/uploads/2022/08/iStock-1311515419-300x169.jpg)](https://qualitysmartsolutions.com/blog/fda-facility-renewal-registration-medical-device-drugs-food-foreign-domestic-sites/) ### [FDA Facility Registration & Renewals (FDA Medical Device, Food & Drugs)](https://qualitysmartsolutions.com/blog/fda-facility-renewal-registration-medical-device-drugs-food-foreign-domestic-sites/) Quality Smart Solutions offers the best FDA Facility Renewal & Registration services in North America for Medical Devices, Food, and ... [Read more](https://qualitysmartsolutions.com/blog/fda-facility-renewal-registration-medical-device-drugs-food-foreign-domestic-sites/) August 13, 2023 [![substantiation reports dossiers FTC regulations](https://qualitysmartsolutions.com/wp-content/uploads/2023/04/QssCLE-Social-Media-Creatives-Additional-2023-04-21T122113.204-300x300.webp)](https://qualitysmartsolutions.com/news/ftc-puts-nearly-700-companies-on-notice-of-product-claim-civil-penalties/) ### [FTC puts nearly 700 companies on notice of product claim civil penalties](https://qualitysmartsolutions.com/news/ftc-puts-nearly-700-companies-on-notice-of-product-claim-civil-penalties/) Introduction: On April 13th, the Federal Trade Commission sent letters to warn hundreds of marketers to refrain from misleading customers with product ... [Read more](https://qualitysmartsolutions.com/news/ftc-puts-nearly-700-companies-on-notice-of-product-claim-civil-penalties/) April 21, 2023 [![HACCP Consultants](https://qualitysmartsolutions.com/wp-content/uploads/2023/01/QSS-Images-2023-01-27T162540.104-300x251.webp)](https://qualitysmartsolutions.com/blog/the-importance-of-haccp-consultants-for-food-safety/) ### [The Importance of HACCP Consultants for Food Safety](https://qualitysmartsolutions.com/blog/the-importance-of-haccp-consultants-for-food-safety/) Introduction: Food safety is an important part of any food business. It’s also a complicated one. There are many regulations ... [Read more](https://qualitysmartsolutions.com/blog/the-importance-of-haccp-consultants-for-food-safety/) March 15, 2023 [![Quality Import Service](https://qualitysmartsolutions.com/wp-content/uploads/2023/03/QSS-Images-2023-03-13T114759.172-e1756507151888-300x123.webp)](https://qualitysmartsolutions.com/blog/5-essential-tips-for-choosing-a-quality-import-service/) ### [How to Choose the Right Importer: 5 Essential Tips](https://qualitysmartsolutions.com/blog/5-essential-tips-for-choosing-a-quality-import-service/) Looking for a quality import service can be a daunting task, but with the right advice and tips, you can ... [Read more](https://qualitysmartsolutions.com/blog/5-essential-tips-for-choosing-a-quality-import-service/) March 13, 2023 [![FDA regulatory comparison of GRAS vs NDI ingredient compliance](https://qualitysmartsolutions.com/wp-content/uploads/2022/12/gras-vs-ndi-300x157.jpg)](https://qualitysmartsolutions.com/blog/gras-vs-ndi-clarification-everything-you-should-know/) ### [GRAS vs NDI: A Simple Guide to Ingredient Compliance](https://qualitysmartsolutions.com/blog/gras-vs-ndi-clarification-everything-you-should-know/) Understanding the differences between GRAS and NDI is essential for any company developing food ingredients or dietary supplements in the ... [Read more](https://qualitysmartsolutions.com/blog/gras-vs-ndi-clarification-everything-you-should-know/) December 6, 2022 [![Nutrition Facts Table CFIA](https://qualitysmartsolutions.com/wp-content/uploads/2022/11/Nutrition-Facts-Table-300x186.webp)](https://qualitysmartsolutions.com/news/cfia-enforcement-of-nutrition-facts-table-food-labelling/) ### [CFIA Enforcement of Nutrition Facts Table & CFIA Labeling Requirements](https://qualitysmartsolutions.com/news/cfia-enforcement-of-nutrition-facts-table-food-labelling/) The Canadian Food Inspection Agency (CFIA) protects Canadians’ health and safety by ensuring food that reaches customers is safe, nutritious, and ... [Read more](https://qualitysmartsolutions.com/news/cfia-enforcement-of-nutrition-facts-table-food-labelling/) November 9, 2022 [![Food Labelling Health Canada Packaging Updates](https://qualitysmartsolutions.com/wp-content/uploads/2022/11/iStock-1054857022-300x200.jpg)](https://qualitysmartsolutions.com/news/upcoming-food-labelling-packaging-updates-health-canada/) ### [Food Labelling & Health Canada Packaging Update for 2023](https://qualitysmartsolutions.com/news/upcoming-food-labelling-packaging-updates-health-canada/) Health Canada Announcement: The Minister of Health has introduced new front-of-package nutrition labeling laws for prepackaged food products, and ... [Read more](https://qualitysmartsolutions.com/news/upcoming-food-labelling-packaging-updates-health-canada/) November 3, 2022 [![FDA FSVP Certification](https://qualitysmartsolutions.com/wp-content/uploads/2022/09/fda_bg-300x224.jpg)](https://qualitysmartsolutions.com/blog/fsvp-checklist-unlock-7-steps-to-verifying-your-fsvp/) ### [Unlock 7 Steps to Verifying Your FSVP in 2023](https://qualitysmartsolutions.com/blog/fsvp-checklist-unlock-7-steps-to-verifying-your-fsvp/) Foreign Supplier Verification Program (FSVP) Due to the increasingly global nature of today’s industry, an increasing number of businesses are ... [Read more](https://qualitysmartsolutions.com/blog/fsvp-checklist-unlock-7-steps-to-verifying-your-fsvp/) October 11, 2022 [![FSMA-FSVP Certification and FSVP Plan](https://qualitysmartsolutions.com/wp-content/uploads/2022/08/iStock-1352815092-300x200.jpg)](https://qualitysmartsolutions.com/blog/what-you-should-know-about-fsma-fsvp-certification-fsvp-plan/) ### [FSVP Plan: Levels of FSMA-FSVP Certification](https://qualitysmartsolutions.com/blog/what-you-should-know-about-fsma-fsvp-certification-fsvp-plan/) The FSVP Plan is a requirement for many companies to be FSMA compliant. It is the responsibility of the company ... [Read more](https://qualitysmartsolutions.com/blog/what-you-should-know-about-fsma-fsvp-certification-fsvp-plan/) September 22, 2022 [![HACCP, PCP, GMP, GFSI Certification](https://qualitysmartsolutions.com/wp-content/uploads/2022/08/iStock-1144337567-300x200.jpg)](https://qualitysmartsolutions.com/blog/what-are-haccp-pcp-requirements-for-gfsi-certification/) ### [What are (HACCP & PCP) Requirements for GFSI Certification?](https://qualitysmartsolutions.com/blog/what-are-haccp-pcp-requirements-for-gfsi-certification/) https://youtu.be/XRZ87ifRki0 Since the publishing of the Safe Foods for Canadians Regulations in 2017, there is now a requirement for a ... [Read more](https://qualitysmartsolutions.com/blog/what-are-haccp-pcp-requirements-for-gfsi-certification/) September 1, 2022 [![Supplemented Foods Health Canada](https://qualitysmartsolutions.com/wp-content/uploads/2022/07/CLE-Blogs-images-5-300x251.webp)](https://qualitysmartsolutions.com/news/supplemented-foods-food-drug-regulations/) ### [Supplemented Foods: Food & Drug Regulations Unlocked in 2023](https://qualitysmartsolutions.com/news/supplemented-foods-food-drug-regulations/) Have you been anticipating the Food and Drug Regulations (FDR) adding supplemented foods as an official category of food? ... [Read more](https://qualitysmartsolutions.com/news/supplemented-foods-food-drug-regulations/) July 26, 2022 [![Learn why food labelling matters for compliance, safety, and informed choices. Discover the key benefits of clear and accurate food labels](https://qualitysmartsolutions.com/wp-content/uploads/2022/06/Why-Food-Labelling-is-Important-300x300.webp)](https://qualitysmartsolutions.com/blog/5-reasons-why-food-labelling-is-important-for-your-business/) ### [5 Reasons Why Food Labelling Is Important for Your Business](https://qualitysmartsolutions.com/blog/5-reasons-why-food-labelling-is-important-for-your-business/) Have you ever looked at a food label and wondered why all that information is there? Labels do more than ... [Read more](https://qualitysmartsolutions.com/blog/5-reasons-why-food-labelling-is-important-for-your-business/) June 7, 2022 [![](https://qualitysmartsolutions.com/wp-content/uploads/2021/10/How-to-Risk-Detention-of-CPG-at-the-border-300x157.jpg)](https://qualitysmartsolutions.com/blog/how-to-risk-detention-of-cpg-at-the-border/) ### [How to Risk Detention of CPG at the border](https://qualitysmartsolutions.com/blog/how-to-risk-detention-of-cpg-at-the-border/) How to Minimize the Risk of Border Detention Shipping Consumer Packaged Goods As an importer of consumer packaged goods, unanticipated ... [Read more](https://qualitysmartsolutions.com/blog/how-to-risk-detention-of-cpg-at-the-border/) October 25, 2021 [![](https://qualitysmartsolutions.com/wp-content/uploads/2021/10/Routine-Inspection-of-your-Licensed-Food-Facility-300x157.jpg)](https://qualitysmartsolutions.com/blog/benefits-of-routine-inspection-of-your-licensed-food-facility/) ### [Benefits of Routine Inspection of your Licensed Food Facility](https://qualitysmartsolutions.com/blog/benefits-of-routine-inspection-of-your-licensed-food-facility/) Inspection of your food facility will help identify and fix any quality or processing deviations found regarding food safety. Review ... [Read more](https://qualitysmartsolutions.com/blog/benefits-of-routine-inspection-of-your-licensed-food-facility/) October 20, 2021 [![](https://qualitysmartsolutions.com/wp-content/uploads/2021/09/Untitled-1-300x193.jpg)](https://qualitysmartsolutions.com/news/cfia-and-health-canada-joint-policy-statement-on-food-labelling-coordination/) ### [CFIA & Health Canada Policy on Food Labelling](https://qualitysmartsolutions.com/news/cfia-and-health-canada-joint-policy-statement-on-food-labelling-coordination/) Health Canada and the CFIA (Canadian Food Inspection Agency) are teaming up to plan advancements and improvements for the timing ... [Read more](https://qualitysmartsolutions.com/news/cfia-and-health-canada-joint-policy-statement-on-food-labelling-coordination/) September 8, 2021 [![](https://qualitysmartsolutions.com/wp-content/uploads/2021/07/food-allergean-300x193.jpg)](https://qualitysmartsolutions.com/news/fdas-addition-of-the-9th-allergen-sesame/) ### [FDA’s Addition of the 9th Allergen (Sesame)](https://qualitysmartsolutions.com/news/fdas-addition-of-the-9th-allergen-sesame/) Sesame will become the 9th major food allergen officially recognized by the United States (FDA) on January 1st, 2023. The ... [Read more](https://qualitysmartsolutions.com/news/fdas-addition-of-the-9th-allergen-sesame/) June 9, 2021 [![](https://qualitysmartsolutions.com/wp-content/uploads/2021/05/human_milk-300x138.jpg)](https://qualitysmartsolutions.com/news/coming-into-force-human-milk-fortifiers-regulations/) ### [Coming into Force: Human Milk Fortifiers Regulations](https://qualitysmartsolutions.com/news/coming-into-force-human-milk-fortifiers-regulations/) After consultation with stakeholders and based on a noticeable lack of current regulations and need for availability and innovation for ... [Read more](https://qualitysmartsolutions.com/news/coming-into-force-human-milk-fortifiers-regulations/) May 7, 2021 [![](https://qualitysmartsolutions.com/wp-content/uploads/2018/09/safe-food-inspection-300x193.jpg)](https://qualitysmartsolutions.com/blog/sfcr-what-to-expect-when-youre-inspected/) ### [SFCR: What to expect when you’re inspected?](https://qualitysmartsolutions.com/blog/sfcr-what-to-expect-when-youre-inspected/) The Safe Food for Canadians Act (SFCA) and the Safe Food for Canadians Regulations (SFCR) are set to come into ... [Read more](https://qualitysmartsolutions.com/blog/sfcr-what-to-expect-when-youre-inspected/) September 2, 2018 We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Food Labelling Guidelines [Skip to content](https://qualitysmartsolutions.com/topic/food-labelling#content) # Food Labelling Search Search \[searchwp\_form id=1\] \[blog\_list\] [![Navigating French Language Labeling Requirements in Canada: A Guide for Food Manufacturers](https://qualitysmartsolutions.com/wp-content/uploads/2023/09/QssCLE-Social-Media-Creatives-Additional-2023-09-27T154315.655-300x300.webp)](https://qualitysmartsolutions.com/blog/french-label-requirements-canada-food-labeling-mistakes/) ### [Navigating French Language Labeling Requirements in Canada: A Guide for Food Manufacturers](https://qualitysmartsolutions.com/blog/french-label-requirements-canada-food-labeling-mistakes/) Introduction: As a food manufacturer in Canada, ensuring that your product labels comply with Health Canada’s regulations is crucial for ... [Read more](https://qualitysmartsolutions.com/blog/french-label-requirements-canada-food-labeling-mistakes/) September 27, 2023 [![Food Labelling Food Regulations](https://qualitysmartsolutions.com/wp-content/uploads/2023/08/QssCLE-Social-Media-Creatives-Additional-2023-08-23T140123.092-300x300.webp)](https://qualitysmartsolutions.com/blog/food-label-requirements-guide-health-canada-fda-eu/) ### [Decoding Food Labeling Regulations: Unveiling Requirements on Food Labels](https://qualitysmartsolutions.com/blog/food-label-requirements-guide-health-canada-fda-eu/) Understanding Food Labels: A Simple Guide Food labels are more than just ingredient stickers on packaging; they are a key ... [Read more](https://qualitysmartsolutions.com/blog/food-label-requirements-guide-health-canada-fda-eu/) August 23, 2023 [![Food Labelling Health Canada Packaging Updates](https://qualitysmartsolutions.com/wp-content/uploads/2022/11/iStock-1054857022-300x200.jpg)](https://qualitysmartsolutions.com/news/upcoming-food-labelling-packaging-updates-health-canada/) ### [Food Labelling & Health Canada Packaging Update for 2023](https://qualitysmartsolutions.com/news/upcoming-food-labelling-packaging-updates-health-canada/) Health Canada Announcement: The Minister of Health has introduced new front-of-package nutrition labeling laws for prepackaged food products, and ... [Read more](https://qualitysmartsolutions.com/news/upcoming-food-labelling-packaging-updates-health-canada/) November 3, 2022 [![Supplemented Foods Health Canada](https://qualitysmartsolutions.com/wp-content/uploads/2022/07/CLE-Blogs-images-5-300x251.webp)](https://qualitysmartsolutions.com/news/supplemented-foods-food-drug-regulations/) ### [Supplemented Foods: Food & Drug Regulations Unlocked in 2023](https://qualitysmartsolutions.com/news/supplemented-foods-food-drug-regulations/) Have you been anticipating the Food and Drug Regulations (FDR) adding supplemented foods as an official category of food? ... [Read more](https://qualitysmartsolutions.com/news/supplemented-foods-food-drug-regulations/) July 26, 2022 [![Nutrition Symbol](https://qualitysmartsolutions.com/wp-content/uploads/2022/07/Nutrition-Symbol-300x156.webp)](https://qualitysmartsolutions.com/news/health-canada-food-directorate-changes-front-of-package-label-regulations/) ### [Nutrition Symbol Front-of-Food-Package Label Regulations](https://qualitysmartsolutions.com/news/health-canada-food-directorate-changes-front-of-package-label-regulations/) Health Canada recently announced that Front-of-package labelling changes for foods are set to come into effect on July 20, 2022, ... [Read more](https://qualitysmartsolutions.com/news/health-canada-food-directorate-changes-front-of-package-label-regulations/) July 5, 2022 [![food regulations for food sales](https://qualitysmartsolutions.com/wp-content/uploads/2022/06/QSS-Blog-Images-Updated-24-300x300.webp)](https://qualitysmartsolutions.com/blog/unlock-food-regulations-for-food-sales-health-canada-fda/) ### [Unlock Food Regulations for Food Sales Health Canada & FDA](https://qualitysmartsolutions.com/blog/unlock-food-regulations-for-food-sales-health-canada-fda/) Do you want to learn about the food regulations for food sales in North America? This could include food facility ... [Read more](https://qualitysmartsolutions.com/blog/unlock-food-regulations-for-food-sales-health-canada-fda/) June 27, 2022 [![Learn why food labelling matters for compliance, safety, and informed choices. Discover the key benefits of clear and accurate food labels](https://qualitysmartsolutions.com/wp-content/uploads/2022/06/Why-Food-Labelling-is-Important-300x300.webp)](https://qualitysmartsolutions.com/blog/5-reasons-why-food-labelling-is-important-for-your-business/) ### [5 Reasons Why Food Labelling Is Important for Your Business](https://qualitysmartsolutions.com/blog/5-reasons-why-food-labelling-is-important-for-your-business/) Have you ever looked at a food label and wondered why all that information is there? Labels do more than ... [Read more](https://qualitysmartsolutions.com/blog/5-reasons-why-food-labelling-is-important-for-your-business/) June 7, 2022 We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Food Safety Resources [Skip to content](https://qualitysmartsolutions.com/topic/food-safety#content) # Food Safety Search Search \[searchwp\_form id=1\] \[blog\_list\] [![FDA to revoke Red No. 3 authorization](https://qualitysmartsolutions.com/wp-content/uploads/2025/01/alexander-schimmeck-sWSJNyb6wZ8-unsplash-300x200.jpg)](https://qualitysmartsolutions.com/news/fda-to-revoke-use-of-red-no-3-what-you-need-to-know/) ### [FDA to Revoke Use of Red No. 3: What You Need to Know](https://qualitysmartsolutions.com/news/fda-to-revoke-use-of-red-no-3-what-you-need-to-know/) The FDA has just announced a significant decision: Red No. 3, a widely used synthetic dye in foods and ingested ... [Read more](https://qualitysmartsolutions.com/news/fda-to-revoke-use-of-red-no-3-what-you-need-to-know/) January 17, 2025 [![FDA front-of-package nutrition labeling proposed rule.](https://qualitysmartsolutions.com/wp-content/uploads/2025/01/food-labelling-process-300x200.jpg)](https://qualitysmartsolutions.com/news/whats-behind-the-fdas-new-front-of-package-labeling-proposal/) ### [What’s Behind the FDA’s New Front-of-Package Labeling Proposal?](https://qualitysmartsolutions.com/news/whats-behind-the-fdas-new-front-of-package-labeling-proposal/) The FDA’s proposed front-of-package (FOP) nutrition labeling rule introduces significant changes to how nutritional information is displayed. This proposal reflects ... [Read more](https://qualitysmartsolutions.com/news/whats-behind-the-fdas-new-front-of-package-labeling-proposal/) January 16, 2025 [![Vitafoods 2025](https://qualitysmartsolutions.com/wp-content/uploads/2025/01/event-img-300x200.jpg)](https://qualitysmartsolutions.com/events/vitafoods-india-2025/) ### [VitaFoods India 2025](https://qualitysmartsolutions.com/events/vitafoods-india-2025/) Vitafoods India 2025 is a premier event for the food, beverage, and dietary supplement industries, bringing together professionals, innovators, and ... [Read more](https://qualitysmartsolutions.com/events/vitafoods-india-2025/) January 14, 2025 [![Food Safety Audits](https://qualitysmartsolutions.com/wp-content/uploads/2023/09/QssCLE-Social-Media-Creatives-Additional-2023-09-01T120916.447-300x300.webp)](https://qualitysmartsolutions.com/blog/ghp-gmp-regulatory-food-safety-audits/) ### [Demystifying GHP and GMP Regulatory Food Safety Audits: Why They Matter](https://qualitysmartsolutions.com/blog/ghp-gmp-regulatory-food-safety-audits/) In the realm of food production and processing, safety is paramount. Ensuring our food is free from contaminants and meets ... [Read more](https://qualitysmartsolutions.com/blog/ghp-gmp-regulatory-food-safety-audits/) September 5, 2023 [![Amazon Seller Compliance](https://qualitysmartsolutions.com/wp-content/uploads/2023/05/QssCLE-Social-Media-Creatives-Additional-2023-05-18T144659.577-300x300.webp)](https://qualitysmartsolutions.com/news/health-canada-interim-policy-extension-on-importing-and-selling-infant-formula/) ### [Health Canada interim policy extension on importing and selling infant formula](https://qualitysmartsolutions.com/news/health-canada-interim-policy-extension-on-importing-and-selling-infant-formula/) Introduction: By extending the interim policy on the importation and sale of infant formulas, human milk fortifiers, and dietary products ... [Read more](https://qualitysmartsolutions.com/news/health-canada-interim-policy-extension-on-importing-and-selling-infant-formula/) May 18, 2023 [![From HACCP to CCPs: Understanding the Evolution of Food Safety Standards](https://qualitysmartsolutions.com/wp-content/uploads/2023/05/QssCLE-Social-Media-Creatives-Additional-2023-05-15T121555.475-300x300.webp)](https://qualitysmartsolutions.com/blog/haccp-to-ccps-the-evolution-of-food-safety-standards-unlocked/) ### [From HACCP to CCPs: How Food Safety Standards Have Changed](https://qualitysmartsolutions.com/blog/haccp-to-ccps-the-evolution-of-food-safety-standards-unlocked/) The food industry has undergone a significant transformation in terms of safety and quality control over the years. From the ... [Read more](https://qualitysmartsolutions.com/blog/haccp-to-ccps-the-evolution-of-food-safety-standards-unlocked/) May 15, 2023 [![food handler license](https://qualitysmartsolutions.com/wp-content/uploads/2023/04/QssCLE-Social-Media-Creatives-Additional-2023-04-17T114050.815-300x300.webp)](https://qualitysmartsolutions.com/blog/how-to-get-your-food-handlers-license-ultimate-5-step-guide/) ### [How to get your Food Handlers License: Ultimate 5 step guide](https://qualitysmartsolutions.com/blog/how-to-get-your-food-handlers-license-ultimate-5-step-guide/) https://youtu.be/NN8ZLynq6kE If you work in the food service industry, you may need to obtain food handlers license to ensure that ... [Read more](https://qualitysmartsolutions.com/blog/how-to-get-your-food-handlers-license-ultimate-5-step-guide/) April 17, 2023 [![Labeling Plant Based Milk Alternatives](https://qualitysmartsolutions.com/wp-content/uploads/2023/02/QssCLE-Social-Media-Creatives-Additional-34-300x300.webp)](https://qualitysmartsolutions.com/news/fda-draft-guidance-on-labeling-plant-based-milk-alternatives/) ### [FDA Draft Guidance Labeling Plant Based Milk Alternatives in 2023](https://qualitysmartsolutions.com/news/fda-draft-guidance-on-labeling-plant-based-milk-alternatives/) Introduction: The US Food and Drug Administration (FDA) issued draft guidance for comment today to help ensure appropriate labelling of ... [Read more](https://qualitysmartsolutions.com/news/fda-draft-guidance-on-labeling-plant-based-milk-alternatives/) February 22, 2023 [![HACCP certification process diagram with food safety steps](https://qualitysmartsolutions.com/wp-content/uploads/2023/01/haccp-certification-300x157.jpg)](https://qualitysmartsolutions.com/blog/how-to-develop-a-haccp-plan/) ### [Your Complete Guide to Getting HACCP Certification](https://qualitysmartsolutions.com/blog/how-to-develop-a-haccp-plan/) Most regulations require you to follow HACCP principles rather than hold a formal certificate. HACCP certification demonstrates your commitment to ... [Read more](https://qualitysmartsolutions.com/blog/how-to-develop-a-haccp-plan/) January 21, 2023 [![FDA regulatory comparison of GRAS vs NDI ingredient compliance](https://qualitysmartsolutions.com/wp-content/uploads/2022/12/gras-vs-ndi-300x157.jpg)](https://qualitysmartsolutions.com/blog/gras-vs-ndi-clarification-everything-you-should-know/) ### [GRAS vs NDI: A Simple Guide to Ingredient Compliance](https://qualitysmartsolutions.com/blog/gras-vs-ndi-clarification-everything-you-should-know/) Understanding the differences between GRAS and NDI is essential for any company developing food ingredients or dietary supplements in the ... [Read more](https://qualitysmartsolutions.com/blog/gras-vs-ndi-clarification-everything-you-should-know/) December 6, 2022 [![7 principles Haccp, How to Set up a HACCP or PCP](https://qualitysmartsolutions.com/wp-content/uploads/2022/11/iStock-1026861972-300x200.jpg)](https://qualitysmartsolutions.com/blog/unpacking-haccp-7-principles-how-to-set-up-a-haccp-plan/) ### [HACCP Implementation: A Practical Guide for Food Businesses](https://qualitysmartsolutions.com/blog/unpacking-haccp-7-principles-how-to-set-up-a-haccp-plan/) HACCP, which stands for Hazard Analysis and Critical Control Points, is the cornerstone of food safety plans in the food ... [Read more](https://qualitysmartsolutions.com/blog/unpacking-haccp-7-principles-how-to-set-up-a-haccp-plan/) November 30, 2022 [![FDA warning letter to Food Manufacturers of CBD food products](https://qualitysmartsolutions.com/wp-content/uploads/2022/11/CLE-qssBlogs-images-1-300x251.webp)](https://qualitysmartsolutions.com/news/fda-warning-letters-food-manufacturers-of-cbd-food-products/) ### [5 FDA Warning Letters: Food Manufacturers of CBD Food Products](https://qualitysmartsolutions.com/news/fda-warning-letters-food-manufacturers-of-cbd-food-products/) Introduction On November 21, 2022, the Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition issued warning ... [Read more](https://qualitysmartsolutions.com/news/fda-warning-letters-food-manufacturers-of-cbd-food-products/) November 30, 2022 [![Safe Quality Food Certification SQF Certification Cost, SQF Facility Certifications](https://qualitysmartsolutions.com/wp-content/uploads/2022/11/iStock-1163875312-300x300.jpg)](https://qualitysmartsolutions.com/blog/safe-quality-food-certification-sqf-facility-certifications-sqf-cost/) ### [Safe Quality Food Certification SQF Food Safety Program](https://qualitysmartsolutions.com/blog/safe-quality-food-certification-sqf-facility-certifications-sqf-cost/) Food is one of the most important parts of our lives. We eat it to stay alive, and we eat ... [Read more](https://qualitysmartsolutions.com/blog/safe-quality-food-certification-sqf-facility-certifications-sqf-cost/) November 23, 2022 [![Nutrition Facts Table CFIA](https://qualitysmartsolutions.com/wp-content/uploads/2022/11/Nutrition-Facts-Table-300x186.webp)](https://qualitysmartsolutions.com/news/cfia-enforcement-of-nutrition-facts-table-food-labelling/) ### [CFIA Enforcement of Nutrition Facts Table & CFIA Labeling Requirements](https://qualitysmartsolutions.com/news/cfia-enforcement-of-nutrition-facts-table-food-labelling/) The Canadian Food Inspection Agency (CFIA) protects Canadians’ health and safety by ensuring food that reaches customers is safe, nutritious, and ... [Read more](https://qualitysmartsolutions.com/news/cfia-enforcement-of-nutrition-facts-table-food-labelling/) November 9, 2022 [![FSVP Compliance Record Reviews](https://qualitysmartsolutions.com/wp-content/uploads/2022/11/iStock-1355657113-300x169.jpg)](https://qualitysmartsolutions.com/news/fsvp-compliance-regulatory-assessment-record-keeping/) ### [FSVP Compliance: Regulatory Assessment Record Keeping 2023](https://qualitysmartsolutions.com/news/fsvp-compliance-regulatory-assessment-record-keeping/) U.S.A RRA FDA Draft Guidance: In a recent U.S. Food and Drug Administration (FDA) draft guidance detailing its implementation ... [Read more](https://qualitysmartsolutions.com/news/fsvp-compliance-regulatory-assessment-record-keeping/) November 7, 2022 [![HACCP, PCP, GMP, GFSI Certification](https://qualitysmartsolutions.com/wp-content/uploads/2022/08/iStock-1144337567-300x200.jpg)](https://qualitysmartsolutions.com/blog/what-are-haccp-pcp-requirements-for-gfsi-certification/) ### [What are (HACCP & PCP) Requirements for GFSI Certification?](https://qualitysmartsolutions.com/blog/what-are-haccp-pcp-requirements-for-gfsi-certification/) https://youtu.be/XRZ87ifRki0 Since the publishing of the Safe Foods for Canadians Regulations in 2017, there is now a requirement for a ... [Read more](https://qualitysmartsolutions.com/blog/what-are-haccp-pcp-requirements-for-gfsi-certification/) September 1, 2022 [![food regulations for food sales](https://qualitysmartsolutions.com/wp-content/uploads/2022/06/QSS-Blog-Images-Updated-24-300x300.webp)](https://qualitysmartsolutions.com/blog/unlock-food-regulations-for-food-sales-health-canada-fda/) ### [Unlock Food Regulations for Food Sales Health Canada & FDA](https://qualitysmartsolutions.com/blog/unlock-food-regulations-for-food-sales-health-canada-fda/) Do you want to learn about the food regulations for food sales in North America? This could include food facility ... [Read more](https://qualitysmartsolutions.com/blog/unlock-food-regulations-for-food-sales-health-canada-fda/) June 27, 2022 [![](https://qualitysmartsolutions.com/wp-content/uploads/2021/06/safety-ZQTQ3RB-300x200.jpg)](https://qualitysmartsolutions.com/news/proposed-food-safety-guidance-for-novel-food-regulations-focused-on-plant-breeding/) ### [Proposed Food Safety Guidance for Novel Food Regulations Focused on Plant Breeding](https://qualitysmartsolutions.com/news/proposed-food-safety-guidance-for-novel-food-regulations-focused-on-plant-breeding/) CFIA and Health Canada have been working on new Food Safety guidance documents pertaining to Novel foods focused on plant ... [Read more](https://qualitysmartsolutions.com/news/proposed-food-safety-guidance-for-novel-food-regulations-focused-on-plant-breeding/) June 23, 2021 [![](https://qualitysmartsolutions.com/wp-content/uploads/2021/01/HACCP-Certification-300x200.jpg)](https://qualitysmartsolutions.com/blog/what-is-haccp-and-food-handlers-certification/) ### [What is a HACCP Plan and Food Handler’s (HACCP Certification) in 2023?](https://qualitysmartsolutions.com/blog/what-is-haccp-and-food-handlers-certification/) What is a HACCP Plan? Food safety is always evolving and becoming more complex, as companies require constant updating with ... [Read more](https://qualitysmartsolutions.com/blog/what-is-haccp-and-food-handlers-certification/) April 26, 2020 [![](https://qualitysmartsolutions.com/wp-content/uploads/2018/10/foreign-supplier-300x193.jpg)](https://qualitysmartsolutions.com/blog/foreign-supplier-verification-program-usa-canada-agreement/) ### [Foreign Supplier Verification Program – USA & Canada agreement?](https://qualitysmartsolutions.com/blog/foreign-supplier-verification-program-usa-canada-agreement/) Under the Food Safety Modernization Act (FSMA), the United States (U.S.) started graduated enforcement of the Foreign Supplier Verification Program ... [Read more](https://qualitysmartsolutions.com/blog/foreign-supplier-verification-program-usa-canada-agreement/) October 12, 2018 [![](https://qualitysmartsolutions.com/wp-content/uploads/2021/01/iStock-822765932-300x169.jpg)](https://qualitysmartsolutions.com/blog/why-efsas-role-as-a-regulatory-authority-is-important-to-us/) ### [Why EFSA’s Role as a Regulatory Authority is Important to Us](https://qualitysmartsolutions.com/blog/why-efsas-role-as-a-regulatory-authority-is-important-to-us/) The European Food Safety Authority (EFSA) is a world renowned regulator which is known for its high scientific standards when ... [Read more](https://qualitysmartsolutions.com/blog/why-efsas-role-as-a-regulatory-authority-is-important-to-us/) August 11, 2018 [![](https://qualitysmartsolutions.com/wp-content/uploads/2021/01/iStock-537061549-300x188.jpg)](https://qualitysmartsolutions.com/blog/safe-food-for-canadians-regulations-how-does-it-affect-you/) ### [Safe Food for Canadians Regulations: How Does it Affect You?](https://qualitysmartsolutions.com/blog/safe-food-for-canadians-regulations-how-does-it-affect-you/) The Safe Food for Canadians Act (SFCA) and the Safe Food for Canadians Regulations (SFCR) are set to come into ... [Read more](https://qualitysmartsolutions.com/blog/safe-food-for-canadians-regulations-how-does-it-affect-you/) July 5, 2018 We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## FSMA and FSVP Overview [Skip to content](https://qualitysmartsolutions.com/topic/fsma-fsvp#content) # FSMA-FSVP Search Search \[searchwp\_form id=1\] \[blog\_list\] [![FSMA Assurance](https://qualitysmartsolutions.com/wp-content/uploads/2023/08/QssCLE-Social-Media-Creatives-Additional-2023-08-29T152340.211-300x300.webp)](https://qualitysmartsolutions.com/blog/fsma-assurance-guide-food-safety/) ### [How FSMA Strengthens Food Safety Compliance](https://qualitysmartsolutions.com/blog/fsma-assurance-guide-food-safety/) The Food Safety Modernization Act (FSMA) Made Simple Imagine a world where preventing food-related illnesses is more important than dealing ... [Read more](https://qualitysmartsolutions.com/blog/fsma-assurance-guide-food-safety/) September 9, 2023 [![fsvp certificate](https://qualitysmartsolutions.com/wp-content/uploads/2023/07/QssCLE-Social-Media-Creatives-Additional-2023-07-11T161909.219-300x300.webp)](https://qualitysmartsolutions.com/blog/build-trust-credibility-in-your-food-business-with-a-fsvp-certificate/) ### [Building trust & credibility in your food business with a FSVP Certificate](https://qualitysmartsolutions.com/blog/build-trust-credibility-in-your-food-business-with-a-fsvp-certificate/) Consumers today are more careful about the food they buy.They want to know their food is safe, high quality, and ... [Read more](https://qualitysmartsolutions.com/blog/build-trust-credibility-in-your-food-business-with-a-fsvp-certificate/) July 11, 2023 [![GFSI Certified in an FSMA Environment](https://qualitysmartsolutions.com/wp-content/uploads/2023/01/QSS-Images-2023-01-27T143552.056-300x251.webp)](https://qualitysmartsolutions.com/blog/what-does-it-mean-to-be-gfsi-certified-in-an-fsma-environment/) ### [What Does It Mean to be GFSI Certified in an FSMA Environment?](https://qualitysmartsolutions.com/blog/what-does-it-mean-to-be-gfsi-certified-in-an-fsma-environment/) Introduction: FSMA stands for the “Food Safety Modernization Act” which is a set of laws enacted by the US government ... [Read more](https://qualitysmartsolutions.com/blog/what-does-it-mean-to-be-gfsi-certified-in-an-fsma-environment/) February 1, 2023 [![FDA FSVP Certification](https://qualitysmartsolutions.com/wp-content/uploads/2022/09/fda_bg-300x224.jpg)](https://qualitysmartsolutions.com/blog/fsvp-checklist-unlock-7-steps-to-verifying-your-fsvp/) ### [Unlock 7 Steps to Verifying Your FSVP in 2023](https://qualitysmartsolutions.com/blog/fsvp-checklist-unlock-7-steps-to-verifying-your-fsvp/) Foreign Supplier Verification Program (FSVP) Due to the increasingly global nature of today’s industry, an increasing number of businesses are ... [Read more](https://qualitysmartsolutions.com/blog/fsvp-checklist-unlock-7-steps-to-verifying-your-fsvp/) October 11, 2022 [![FSMA-FSVP Certification and FSVP Plan](https://qualitysmartsolutions.com/wp-content/uploads/2022/08/iStock-1352815092-300x200.jpg)](https://qualitysmartsolutions.com/blog/what-you-should-know-about-fsma-fsvp-certification-fsvp-plan/) ### [FSVP Plan: Levels of FSMA-FSVP Certification](https://qualitysmartsolutions.com/blog/what-you-should-know-about-fsma-fsvp-certification-fsvp-plan/) The FSVP Plan is a requirement for many companies to be FSMA compliant. It is the responsibility of the company ... [Read more](https://qualitysmartsolutions.com/blog/what-you-should-know-about-fsma-fsvp-certification-fsvp-plan/) September 22, 2022 We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## FSVP Importer Compliance [Skip to content](https://qualitysmartsolutions.com/topic/fsvp-importer#content) # FSVP Importer Search Search \[searchwp\_form id=1\] \[blog\_list\] [![A Comprehensive Guide to FSVP Rules and Records for Importers Introduction:](https://qualitysmartsolutions.com/wp-content/uploads/2023/08/QssCLE-Social-Media-Creatives-Additional-2023-08-31T150334.255-300x300.webp)](https://qualitysmartsolutions.com/blog/fsvp-rules-records-for-importers/) ### [Understanding FSVP Rules and How to Stay Compliant](https://qualitysmartsolutions.com/blog/fsvp-rules-records-for-importers/) For importers in the global food trade, ensuring the safety and compliance of imported products is a top priority. The ... [Read more](https://qualitysmartsolutions.com/blog/fsvp-rules-records-for-importers/) September 13, 2023 [![Everything you should know before choosing an FSVP Agent for Import/Export](https://qualitysmartsolutions.com/wp-content/uploads/2023/08/QssCLE-Social-Media-Creatives-Additional-2023-08-31T150321.654-300x300.webp)](https://qualitysmartsolutions.com/blog/fsvp-agent-benefits-importers-exporters/) ### [FSVP Planning: Everything you should know before choosing an FSVP Agent for Import/Export](https://qualitysmartsolutions.com/blog/fsvp-agent-benefits-importers-exporters/) https://youtu.be/T3pLp1dF08Y Introduction: In the intricate world of global trade, ensuring the safety and compliance of imported and exported food products ... [Read more](https://qualitysmartsolutions.com/blog/fsvp-agent-benefits-importers-exporters/) September 7, 2023 [![USA Import Services](https://qualitysmartsolutions.com/wp-content/uploads/2023/07/QssCLE-Social-Media-Creatives-Additional-2023-07-18T150029.724-300x300.webp)](https://qualitysmartsolutions.com/blog/from-customs-clearance-to-delivery-how-usa-import-services-can-benefit-your-supply-chain/) ### [From customs clearance to delivery: How USA Import Services can benefit your supply chain](https://qualitysmartsolutions.com/blog/from-customs-clearance-to-delivery-how-usa-import-services-can-benefit-your-supply-chain/) In today’s global economy, businesses increasingly use international trade to source materials and sell products. However, the complex regulations ... [Read more](https://qualitysmartsolutions.com/blog/from-customs-clearance-to-delivery-how-usa-import-services-can-benefit-your-supply-chain/) July 18, 2023 [![FSVP Importer Requirements](https://qualitysmartsolutions.com/wp-content/uploads/2023/05/QssCLE-Social-Media-Creatives-Additional-2023-05-03T122031.200-300x300.webp)](https://qualitysmartsolutions.com/blog/fsvp-importer-requirements-a-comprehensive-overview/) ### [Why an FSVP Importer Is Essential for Food Safety](https://qualitysmartsolutions.com/blog/fsvp-importer-requirements-a-comprehensive-overview/) As our world becomes increasingly globalized, the importation of food has become a common practice. However, with growing concerns ... [Read more](https://qualitysmartsolutions.com/blog/fsvp-importer-requirements-a-comprehensive-overview/) May 3, 2023 We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## GRAS Substance Information [Skip to content](https://qualitysmartsolutions.com/topic/gras#content) # GRAS Search Search \[searchwp\_form id=1\] \[blog\_list\] [![](https://qualitysmartsolutions.com/wp-content/uploads/2023/11/person-showing-thumbsup-sign-chopping-table-fresh-healthy-food-1-300x200.jpg)](https://qualitysmartsolutions.com/blog/navigating-gras-panels-a-guide-to-best-practices/) ### [Navigating GRAS Panels: A Guide to Best Practices](https://qualitysmartsolutions.com/blog/navigating-gras-panels-a-guide-to-best-practices/) When it comes to introducing new substances into the world of food and dietary supplements, ensuring safety is paramount. The ... [Read more](https://qualitysmartsolutions.com/blog/navigating-gras-panels-a-guide-to-best-practices/) November 6, 2023 [![GRAS Notice vs Self-Affirmed GRAS](https://qualitysmartsolutions.com/wp-content/uploads/2025/04/GRAS-Noitce-vs-Self-Affirmed-Blog-300x169.jpg)](https://qualitysmartsolutions.com/blog/gras-notice-vs-self-affirmed-gras/) ### [Choosing Between GRAS Notice and Self-Affirmed GRAS](https://qualitysmartsolutions.com/blog/gras-notice-vs-self-affirmed-gras/) If you’re introducing a new ingredient or additive into food products, understanding the GRAS Notice vs. Self-Affirmed GRAS pathways is ... [Read more](https://qualitysmartsolutions.com/blog/gras-notice-vs-self-affirmed-gras/) October 31, 2023 [![GRAS substances used in food, pharmaceuticals, and cosmetics](https://qualitysmartsolutions.com/wp-content/uploads/2023/10/GRAS-300x169.jpg)](https://qualitysmartsolutions.com/blog/gras-substances-compliance-guide/) ### [Understanding GRAS Substances and Their Role in Food Compliance](https://qualitysmartsolutions.com/blog/gras-substances-compliance-guide/) GRAS substances, or “Generally Recognized as Safe” substances, are essential to product development in the food, pharmaceutical, and cosmetic industries. ... [Read more](https://qualitysmartsolutions.com/blog/gras-substances-compliance-guide/) October 26, 2023 [![](https://qualitysmartsolutions.com/wp-content/uploads/2023/05/QssCLE-Social-Media-Creatives-Additional-2023-05-25T105513.032-300x300.webp)](https://qualitysmartsolutions.com/blog/why-fsvp-certification-is-critical-in-the-global-food-supply-chain/) ### [The Role of FSVP Certification in Global Food Safety](https://qualitysmartsolutions.com/blog/why-fsvp-certification-is-critical-in-the-global-food-supply-chain/) In today’s global food supply chain, ensuring the safety and quality of food products is critical to protecting public health ... [Read more](https://qualitysmartsolutions.com/blog/why-fsvp-certification-is-critical-in-the-global-food-supply-chain/) May 25, 2023 [![GRAS List for Food Additives](https://qualitysmartsolutions.com/wp-content/uploads/2023/03/QssCLE-Social-Media-Creatives-Additional-2023-03-28T160731.262-300x300.webp)](https://qualitysmartsolutions.com/blog/gras-list-for-food-additives-your-guide-to-safety/) ### [GRAS List for Food Additives – Your Step-by-Step Guide to Safety](https://qualitysmartsolutions.com/blog/gras-list-for-food-additives-your-guide-to-safety/) https://youtu.be/wOKeuDAEfss Have you ever wondered what goes into the food you eat every day? Various food additives enhance our food’s ... [Read more](https://qualitysmartsolutions.com/blog/gras-list-for-food-additives-your-guide-to-safety/) April 5, 2023 [![FDA GRAS database with safe food ingredients list](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/pexels-tima-miroshnichenko-6549358-scaled-e1748277937336-300x144.jpg)](https://qualitysmartsolutions.com/blog/how-to-use-the-fda-gras-database-for-safe-food-ingredients/) ### [Making the Most of the FDA GRAS Database for Ingredient Safety](https://qualitysmartsolutions.com/blog/how-to-use-the-fda-gras-database-for-safe-food-ingredients/) If you’re in the food or ingredient industry, you’ve likely heard about the FDA GRAS database. It’s a vital resource ... [Read more](https://qualitysmartsolutions.com/blog/how-to-use-the-fda-gras-database-for-safe-food-ingredients/) January 18, 2023 [![Food Classification NDI, ODI, GRAS Food Additives](https://qualitysmartsolutions.com/wp-content/uploads/2022/12/QSS-Images-3-300x251.webp)](https://qualitysmartsolutions.com/blog/gras-ndi-odi-food-additives-food-classification/) ### [GRAS, NDI, ODI Food Additives & Generally Recognized as Safe GRAS](https://qualitysmartsolutions.com/blog/gras-ndi-odi-food-additives-food-classification/) Introduction Food additives are chemicals added to food products to enhance flavor, texture, or color. Fortunately, there is a list ... [Read more](https://qualitysmartsolutions.com/blog/gras-ndi-odi-food-additives-food-classification/) December 21, 2022 We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## HACCP Overview [Skip to content](https://qualitysmartsolutions.com/topic/haccp#content) # HACCP Search Search \[searchwp\_form id=1\] \[blog\_list\] [![HACCP Regulations: A Experts Guide for Industry Compliance](https://qualitysmartsolutions.com/wp-content/uploads/2023/08/QssCLE-Social-Media-Creatives-Additional-2023-08-28T141321.390-300x300.webp)](https://qualitysmartsolutions.com/blog/haccp-regulations-comprehensive-guide/) ### [Navigating HACCP Regulations: A Comprehensive Guide for Industry Compliance](https://qualitysmartsolutions.com/blog/haccp-regulations-comprehensive-guide/) https://youtu.be/dVbug89UHBA In today’s fast-paced and diverse industries, pursuing safety and quality isn’t just a goal; it’s a non-negotiable commitment. This ... [Read more](https://qualitysmartsolutions.com/blog/haccp-regulations-comprehensive-guide/) August 28, 2023 [![haccp process](https://qualitysmartsolutions.com/wp-content/uploads/2023/07/QssCLE-Social-Media-Creatives-Additional-2023-07-07T161813.053-300x300.webp)](https://qualitysmartsolutions.com/blog/haccp-process-critical-control-points-hazard-analysis/) ### [From Hazard Analysis to Critical Control Points: A Deep Dive into the HACCP Process](https://qualitysmartsolutions.com/blog/haccp-process-critical-control-points-hazard-analysis/) https://youtu.be/dVbug89UHBA Welcome to a comprehensive Hazard Analysis and Critical Control Points HACCP process exploration. In today’s world, ensuring the safety ... [Read more](https://qualitysmartsolutions.com/blog/haccp-process-critical-control-points-hazard-analysis/) July 7, 2023 [![HACCP Certification Critical Control Points](https://qualitysmartsolutions.com/wp-content/uploads/2023/04/QssCLE-Social-Media-Creatives-Additional-2023-04-13T105515.458-300x300.webp)](https://qualitysmartsolutions.com/blog/the-role-of-critical-control-points-in-haccp-certification-in-2023/) ### [The role of Critical Control Points in your HACCP Plan](https://qualitysmartsolutions.com/blog/the-role-of-critical-control-points-in-haccp-certification-in-2023/) https://youtu.be/dVbug89UHBA In the food industry, ensuring the safety of the products you produce is of utmost importance. One key aspect ... [Read more](https://qualitysmartsolutions.com/blog/the-role-of-critical-control-points-in-haccp-certification-in-2023/) April 13, 2023 [![7 principles Haccp, How to Set up a HACCP or PCP](https://qualitysmartsolutions.com/wp-content/uploads/2022/11/iStock-1026861972-300x200.jpg)](https://qualitysmartsolutions.com/blog/unpacking-haccp-7-principles-how-to-set-up-a-haccp-plan/) ### [HACCP Implementation: A Practical Guide for Food Businesses](https://qualitysmartsolutions.com/blog/unpacking-haccp-7-principles-how-to-set-up-a-haccp-plan/) HACCP, which stands for Hazard Analysis and Critical Control Points, is the cornerstone of food safety plans in the food ... [Read more](https://qualitysmartsolutions.com/blog/unpacking-haccp-7-principles-how-to-set-up-a-haccp-plan/) November 30, 2022 We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Health Canada Information [Skip to content](https://qualitysmartsolutions.com/topic/health-canada#content) # Health Canada Search Search \[searchwp\_form id=1\] \[blog\_list\] [![Health Canada Prescription Drug List amendment restricting melatonin to prescription-only for pediatric use in Canada](https://qualitysmartsolutions.com/wp-content/uploads/2026/06/pediatric-melatonin-prescription-drug-Canada-300x157.jpg)](https://qualitysmartsolutions.com/news/health-canada-amends-prescription-drug-list-to-require-a-prescription-for-pediatric-melatonin-use/) ### [Health Canada Amends Prescription Drug List to Require a Prescription for Pediatric Melatonin Use](https://qualitysmartsolutions.com/news/health-canada-amends-prescription-drug-list-to-require-a-prescription-for-pediatric-melatonin-use/) Health Canada has amended the Prescription Drug List (PDL) to require a prescription for all sleep-related use of melatonin in ... [Read more](https://qualitysmartsolutions.com/news/health-canada-amends-prescription-drug-list-to-require-a-prescription-for-pediatric-melatonin-use/) June 10, 2026 [![Health Canada fees 2026 overview for medical devices drugs and cannabis](https://qualitysmartsolutions.com/wp-content/uploads/2026/01/health-canada-2026-news-300x157.jpg)](https://qualitysmartsolutions.com/news/what-you-need-to-know-about-health-canada-fees-in-2026/) ### [Health Canada Fees 2026: Updates for Devices, Drugs & Cannabis](https://qualitysmartsolutions.com/news/what-you-need-to-know-about-health-canada-fees-in-2026/) Health Canada has updated its fees effective April 1, 2026, with changes applying across multiple regulated sectors, including medical devices, ... [Read more](https://qualitysmartsolutions.com/news/what-you-need-to-know-about-health-canada-fees-in-2026/) January 6, 2026 [![MDSAP audit process for medical device compliance](https://qualitysmartsolutions.com/wp-content/uploads/2025/04/medical-devices-300x200.jpg)](https://qualitysmartsolutions.com/blog/what-is-mdsap-and-why-does-it-matter/) ### [Understanding the Importance of MDSAP Certification](https://qualitysmartsolutions.com/blog/what-is-mdsap-and-why-does-it-matter/) If you’re working in the medical device space and looking to expand into the Canadian market, here’s a question for ... [Read more](https://qualitysmartsolutions.com/blog/what-is-mdsap-and-why-does-it-matter/) April 3, 2025 [![Grape Seed Extract Allowed in Foods by Health Canada](https://qualitysmartsolutions.com/wp-content/uploads/2025/01/grape-seeds-300x141.jpg)](https://qualitysmartsolutions.com/news/understanding-health-canadas-approval-on-grape-seed-extract-in-foods/) ### [Understanding Health Canada’s Approval on Grape Seed Extract in Foods](https://qualitysmartsolutions.com/news/understanding-health-canadas-approval-on-grape-seed-extract-in-foods/) Health Canada has made an important decision regarding grape seed extract, now approved for use as a supplemental ingredient in ... [Read more](https://qualitysmartsolutions.com/news/understanding-health-canadas-approval-on-grape-seed-extract-in-foods/) January 20, 2025 [![Health Canada drug submission pathways explained: NDS, SNDS, ANDS](https://qualitysmartsolutions.com/wp-content/uploads/2024/11/Health-Canadas-drug-300x181.jpg)](https://qualitysmartsolutions.com/blog/health-canadas-nds-snds-and-ands-pathways-which-one-is-right-for-you/) ### [Health Canada’s NDS, SNDS, and ANDS Pathways: Which One Is Right for You?](https://qualitysmartsolutions.com/blog/health-canadas-nds-snds-and-ands-pathways-which-one-is-right-for-you/) If you’re thinking about bringing a pharmaceutical product to the Canadian market, getting familiar with drug submission pathways is a ... [Read more](https://qualitysmartsolutions.com/blog/health-canadas-nds-snds-and-ands-pathways-which-one-is-right-for-you/) November 1, 2024 [![Health Canada fees](https://qualitysmartsolutions.com/wp-content/uploads/2023/06/QssCLE-Social-Media-Creatives-Additional-2023-06-15T144819.211-300x300.webp)](https://qualitysmartsolutions.com/blog/what-health-businesses-should-know-about-health-canada-fees/) ### [A Guide to Health Canada Compliance for Health Businesses](https://qualitysmartsolutions.com/blog/what-health-businesses-should-know-about-health-canada-fees/) In the ever-evolving healthcare landscape, staying up-to-date with the latest regulations and requirements is crucial for health professionals. And when ... [Read more](https://qualitysmartsolutions.com/blog/what-health-businesses-should-know-about-health-canada-fees/) June 15, 2023 [![Health Canada Medical Devices Regulations](https://qualitysmartsolutions.com/wp-content/uploads/2023/02/QssCLE-Social-Media-Creatives-Additional-2-300x300.webp)](https://qualitysmartsolutions.com/blog/how-to-comply-with-health-canada-regulations-for-medical-devices/) ### [How to comply with Health Canada Regulations for Medical Devices?](https://qualitysmartsolutions.com/blog/how-to-comply-with-health-canada-regulations-for-medical-devices/) Introduction: Manufacturing and selling medical devices in Canada can be a complex process and requires adherence to Health Canada’s ... [Read more](https://qualitysmartsolutions.com/blog/how-to-comply-with-health-canada-regulations-for-medical-devices/) March 22, 2023 [![Health Canada](https://qualitysmartsolutions.com/wp-content/uploads/2023/03/QSS-Images-2023-03-07T152718.447-300x251.webp)](https://qualitysmartsolutions.com/news/mdel-del-din-prma-application-fee-amendments-for-2023/) ### [MDEL, DEL, DIN & PRMA Application Fee Amendments for 2023](https://qualitysmartsolutions.com/news/mdel-del-din-prma-application-fee-amendments-for-2023/) PMRA Annual Fees reduced for Reporting and Applications: Health Canada is implementing a new approach beginning April 1, 2023. The ... [Read more](https://qualitysmartsolutions.com/news/mdel-del-din-prma-application-fee-amendments-for-2023/) March 7, 2023 [![GFSI Certification Benchmarking Audit](https://qualitysmartsolutions.com/wp-content/uploads/2022/12/QSS-Images-6-300x251.webp)](https://qualitysmartsolutions.com/blog/how-to-get-gfsi-certification-a-step-by-step-guide/) ### [Steps to Achieve GFSI Certification for Your Business](https://qualitysmartsolutions.com/blog/how-to-get-gfsi-certification-a-step-by-step-guide/) https://youtu.be/XRZ87ifRki0 Ensuring the safety and quality of your food products is crucial for building trust with your customers and expanding ... [Read more](https://qualitysmartsolutions.com/blog/how-to-get-gfsi-certification-a-step-by-step-guide/) January 4, 2023 [![regulatory enrolment process REP](https://qualitysmartsolutions.com/wp-content/uploads/2022/09/iStock-1361573102-300x150.jpg)](https://qualitysmartsolutions.com/blog/health-canadas-regulatory-enrollment-process-rep/) ### [Health Canada’s Regulatory Enrollment Process (REP): Top 4 things to know](https://qualitysmartsolutions.com/blog/health-canadas-regulatory-enrollment-process-rep/) Industry people and experts considering working with a company not registered with Health Canada should be aware of the regulatory ... [Read more](https://qualitysmartsolutions.com/blog/health-canadas-regulatory-enrollment-process-rep/) September 9, 2022 [![Product Classification in Canada: Drug, NHP, or Cosmetic?](https://qualitysmartsolutions.com/wp-content/uploads/2022/06/Product-Classification-300x169.jpg)](https://qualitysmartsolutions.com/blog/how-to-classify-your-product-as-a-drug-nhp-or-cosmetic/) ### [Classifying Your Product: Drug, NHP, or Cosmetic?](https://qualitysmartsolutions.com/blog/how-to-classify-your-product-as-a-drug-nhp-or-cosmetic/) Learning how to classify your product correctly is one of the most important first steps when entering the Canadian market. ... [Read more](https://qualitysmartsolutions.com/blog/how-to-classify-your-product-as-a-drug-nhp-or-cosmetic/) June 9, 2022 We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Importer of Record Guide [Skip to content](https://qualitysmartsolutions.com/topic/importer-of-record#content) # Importer of Record Search Search \[searchwp\_form id=1\] \[blog\_list\] [![USA IOR compliance](https://qualitysmartsolutions.com/wp-content/uploads/2023/08/IOR-and-custom-duty-300x157.jpg)](https://qualitysmartsolutions.com/blog/ior-compliance-tax-obligations-guide/) ### [IOR Compliance USA: Navigating Regulations and Tax Responsibilities](https://qualitysmartsolutions.com/blog/ior-compliance-tax-obligations-guide/) Introduction: Navigating international trade regulations and the intricacies of Importer of Record (IOR) compliance and taxes can be complex. This ... [Read more](https://qualitysmartsolutions.com/blog/ior-compliance-tax-obligations-guide/) August 24, 2023 [![Imported products custom clearance Importer of Record to Canada](https://qualitysmartsolutions.com/wp-content/uploads/2023/07/Imported-products-custom-clearance-Importer-300x157.jpg)](https://qualitysmartsolutions.com/blog/everything-your-importer-should-do-to-ensure-compliance-and-a-smooth-customs-clearance/) ### [Everything your Importer should do to ensure compliance and a smooth customs clearance](https://qualitysmartsolutions.com/blog/everything-your-importer-should-do-to-ensure-compliance-and-a-smooth-customs-clearance/) https://youtu.be/mWaBQzsa1\_M Introduction In the world of international trade, importers of record play a crucial role in ensuring smooth customs clearance ... [Read more](https://qualitysmartsolutions.com/blog/everything-your-importer-should-do-to-ensure-compliance-and-a-smooth-customs-clearance/) July 11, 2023 [![Importation process IOR Importer of Record](https://qualitysmartsolutions.com/wp-content/uploads/2023/05/import-proceess-300x157.jpg)](https://qualitysmartsolutions.com/blog/maximizing-your-import-process-with-an-importer-of-record/) ### [Streamlining Imports With an Importer of Record](https://qualitysmartsolutions.com/blog/maximizing-your-import-process-with-an-importer-of-record/) Importing goods from other countries can be a lucrative business and a complex and tedious process. As an importer, you ... [Read more](https://qualitysmartsolutions.com/blog/maximizing-your-import-process-with-an-importer-of-record/) May 24, 2023 [![importing products into Canada](https://qualitysmartsolutions.com/wp-content/uploads/2023/05/QssCLE-Social-Media-Creatives-Additional-2023-05-17T132657.131-300x300.webp)](https://qualitysmartsolutions.com/blog/the-ultimate-regulatory-guide-to-importing-products-into-canada/) ### [Everything You Need to Know About Importing Products Into Canada](https://qualitysmartsolutions.com/blog/the-ultimate-regulatory-guide-to-importing-products-into-canada/) If you’re a business owner looking to expand your reach into the Canadian market, importing products may be a viable ... [Read more](https://qualitysmartsolutions.com/blog/the-ultimate-regulatory-guide-to-importing-products-into-canada/) May 17, 2023 [![Importer of Record export](https://qualitysmartsolutions.com/wp-content/uploads/2023/04/QssCLE-Social-Media-Creatives-Additional-2023-04-11T113906.522-300x300.webp)](https://qualitysmartsolutions.com/blog/top-5-benefits-of-hiring-an-importer-of-record-for-international-trade/) ### [Top 5 benefits of hiring an Importer of Record for International Trade](https://qualitysmartsolutions.com/blog/top-5-benefits-of-hiring-an-importer-of-record-for-international-trade/) https://youtu.be/mWaBQzsa1\_M Introduction Importing goods can be a complex process, especially when it comes to navigating customs regulations and compliance requirements. ... [Read more](https://qualitysmartsolutions.com/blog/top-5-benefits-of-hiring-an-importer-of-record-for-international-trade/) April 11, 2023 [![Quality Import Service](https://qualitysmartsolutions.com/wp-content/uploads/2023/03/QSS-Images-2023-03-13T114759.172-e1756507151888-300x123.webp)](https://qualitysmartsolutions.com/blog/5-essential-tips-for-choosing-a-quality-import-service/) ### [How to Choose the Right Importer: 5 Essential Tips](https://qualitysmartsolutions.com/blog/5-essential-tips-for-choosing-a-quality-import-service/) Looking for a quality import service can be a daunting task, but with the right advice and tips, you can ... [Read more](https://qualitysmartsolutions.com/blog/5-essential-tips-for-choosing-a-quality-import-service/) March 13, 2023 We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Medical Devices Resources [Skip to content](https://qualitysmartsolutions.com/topic/medical-devices#content) # Medical Devices Search Search \[searchwp\_form id=1\] \[blog\_list\] [![Health Canada fees 2026 overview for medical devices drugs and cannabis](https://qualitysmartsolutions.com/wp-content/uploads/2026/01/health-canada-2026-news-300x157.jpg)](https://qualitysmartsolutions.com/news/what-you-need-to-know-about-health-canada-fees-in-2026/) ### [Health Canada Fees 2026: Updates for Devices, Drugs & Cannabis](https://qualitysmartsolutions.com/news/what-you-need-to-know-about-health-canada-fees-in-2026/) Health Canada has updated its fees effective April 1, 2026, with changes applying across multiple regulated sectors, including medical devices, ... [Read more](https://qualitysmartsolutions.com/news/what-you-need-to-know-about-health-canada-fees-in-2026/) January 6, 2026 [![](https://qualitysmartsolutions.com/wp-content/uploads/2025/01/Arab-Health-2025.jpeg-300x171.webp)](https://qualitysmartsolutions.com/events/arab-health-2025/) ### [Arab Health 2025](https://qualitysmartsolutions.com/events/arab-health-2025/) Arab Health 2025 is one of the world’s largest healthcare exhibitions. It brings together industry leaders, innovators, and regulatory experts ... [Read more](https://qualitysmartsolutions.com/events/arab-health-2025/) January 15, 2025 [![FDA medical device classification system: Class I, II, and III medical devices.](https://qualitysmartsolutions.com/wp-content/uploads/2024/12/pexels-asphotograpy-1001897-300x200.jpg)](https://qualitysmartsolutions.com/blog/what-are-fda-medical-device-classes/) ### [What Are FDA Medical Device Classes?](https://qualitysmartsolutions.com/blog/what-are-fda-medical-device-classes/) Understanding the FDA classification system for medical devices is key to getting your product to market safely and efficiently. Knowing ... [Read more](https://qualitysmartsolutions.com/blog/what-are-fda-medical-device-classes/) December 17, 2024 [![](https://qualitysmartsolutions.com/wp-content/uploads/2024/11/fda-510-process-300x228.jpg)](https://qualitysmartsolutions.com/blog/fda-510k-pre-submission-steps-for-medical-device-approval/) ### [How to Prepare for an FDA 510(k) Pre-Submission](https://qualitysmartsolutions.com/blog/fda-510k-pre-submission-steps-for-medical-device-approval/) Are you trying to make sense of the FDA’s 510(k) pre-submission process? You’re not alone. Many companies, especially those new ... [Read more](https://qualitysmartsolutions.com/blog/fda-510k-pre-submission-steps-for-medical-device-approval/) November 15, 2024 ### [Understanding FDA FURLS, FDA Approved, and FDA Registered Medical Devices](https://qualitysmartsolutions.com/blog/fda-furls-fda-approved-fda-registered-medical-devices/) The process of bringing medical devices to market in the United States involves stringent regulations imposed by the Food and ... [Read more](https://qualitysmartsolutions.com/blog/fda-furls-fda-approved-fda-registered-medical-devices/) November 2, 2023 [![](https://qualitysmartsolutions.com/wp-content/uploads/2023/10/medical-devices-300x157.jpg)](https://qualitysmartsolutions.com/blog/canadian-medical-device-compliance-importing-mdel-mdl/) ### [How Manufacturers Can Stay Compliant With Canadian Medical Device Rules](https://qualitysmartsolutions.com/blog/canadian-medical-device-compliance-importing-mdel-mdl/) https://youtu.be/E0E0dohMpC4 So, you’re a medical device manufacturer eyeing the Canadian market? Great choice! But before you dive in, let’s talk ... [Read more](https://qualitysmartsolutions.com/blog/canadian-medical-device-compliance-importing-mdel-mdl/) October 18, 2023 [![medical device regulation requirements](https://qualitysmartsolutions.com/wp-content/uploads/2023/09/QssCLE-Social-Media-Creatives-Additional-2023-09-29T122508.539-300x300.webp)](https://qualitysmartsolutions.com/blog/medical-device-requirements-compliance-challenges/) ### [Navigating the Regulatory Seas: How Experts Ensure Your Medical Devices Set Sail Smoothly](https://qualitysmartsolutions.com/blog/medical-device-requirements-compliance-challenges/) Introduction In the ever-changing world of medical device manufacturing, ensuring your product complies with regulations is akin to navigating stormy ... [Read more](https://qualitysmartsolutions.com/blog/medical-device-requirements-compliance-challenges/) September 29, 2023 [![](https://qualitysmartsolutions.com/wp-content/uploads/2023/09/mdl-mdel-license-300x157.jpg)](https://qualitysmartsolutions.com/blog/mlmd-application-submissions/) ### [What the Draft Guidance Means for MLMD Applications](https://qualitysmartsolutions.com/blog/mlmd-application-submissions/) \*This summary of Health Canada’s guidance document provides compliance details for manufacturers submitting a new or amended application. Under the ... [Read more](https://qualitysmartsolutions.com/blog/mlmd-application-submissions/) September 11, 2023 [![In this guide, we'll explore the responsibilities and functions of Del Health Canada in more detail.](https://qualitysmartsolutions.com/wp-content/uploads/2023/08/QssCLE-Social-Media-Creatives-Additional-2023-08-23T140133.690-300x300.webp)](https://qualitysmartsolutions.com/blog/del-health-canada-roles-responsibilities-in-protecting-canadians/) ### [Del Health Canada: Roles & responsibilities in protecting Canadians](https://qualitysmartsolutions.com/blog/del-health-canada-roles-responsibilities-in-protecting-canadians/) Del Health Canada is a crucial regulatory body responsible for ensuring the safety and effectiveness of drugs and medical devices ... [Read more](https://qualitysmartsolutions.com/blog/del-health-canada-roles-responsibilities-in-protecting-canadians/) August 23, 2023 [![FDA Facility Renewal and Registration](https://qualitysmartsolutions.com/wp-content/uploads/2022/08/iStock-1311515419-300x169.jpg)](https://qualitysmartsolutions.com/blog/fda-facility-renewal-registration-medical-device-drugs-food-foreign-domestic-sites/) ### [FDA Facility Registration & Renewals (FDA Medical Device, Food & Drugs)](https://qualitysmartsolutions.com/blog/fda-facility-renewal-registration-medical-device-drugs-food-foreign-domestic-sites/) Quality Smart Solutions offers the best FDA Facility Renewal & Registration services in North America for Medical Devices, Food, and ... [Read more](https://qualitysmartsolutions.com/blog/fda-facility-renewal-registration-medical-device-drugs-food-foreign-domestic-sites/) August 13, 2023 [![Demystifying the Medical Device Regulatory Process: A Guide for Manufacturers](https://qualitysmartsolutions.com/wp-content/uploads/2023/08/QssCLE-Social-Media-Creatives-Additional-2023-08-10T152921.958-300x300.webp)](https://qualitysmartsolutions.com/blog/demystifying-the-medical-device-regulatory-process-a-guide-for-manufacturers/) ### [Demystifying the Medical Device Regulatory Process: A guide for manufacturers](https://qualitysmartsolutions.com/blog/demystifying-the-medical-device-regulatory-process-a-guide-for-manufacturers/) Navigating the complex medical device regulatory process can often feel like decoding a cryptic language. Manufacturers grapple with an intricate ... [Read more](https://qualitysmartsolutions.com/blog/demystifying-the-medical-device-regulatory-process-a-guide-for-manufacturers/) August 10, 2023 [![Medical Device approvals 510(K) V.S. PMA differences & process](https://qualitysmartsolutions.com/wp-content/uploads/2023/07/QssCLE-Social-Media-Creatives-Additional-2023-07-20T155022.271-300x300.webp)](https://qualitysmartsolutions.com/blog/medical-device-approvals-510k-pma/) ### [Decoding the Jargon: Medical Device approvals 510(K) V.S. PMA differences & process](https://qualitysmartsolutions.com/blog/medical-device-approvals-510k-pma/) Are you a medical professional or someone involved in the healthcare industry? If so, you’ve likely come across the ... [Read more](https://qualitysmartsolutions.com/blog/medical-device-approvals-510k-pma/) July 20, 2023 [![FDA Approvals for Drugs & Medical Devices](https://qualitysmartsolutions.com/wp-content/uploads/2023/02/QssCLE-Social-Media-Creatives-Additional-21-300x300.webp)](https://qualitysmartsolutions.com/blog/what-to-know-about-fda-approvals-for-drugs-medical-devices/) ### [What you should know about FDA Approvals for Drugs & Medical Devices](https://qualitysmartsolutions.com/blog/what-to-know-about-fda-approvals-for-drugs-medical-devices/) Introduction: FDA approvals can be a complex process, but understanding its important steps can give you insight into how drugs ... [Read more](https://qualitysmartsolutions.com/blog/what-to-know-about-fda-approvals-for-drugs-medical-devices/) March 27, 2023 [![Health Canada Medical Devices Regulations](https://qualitysmartsolutions.com/wp-content/uploads/2023/02/QssCLE-Social-Media-Creatives-Additional-2-300x300.webp)](https://qualitysmartsolutions.com/blog/how-to-comply-with-health-canada-regulations-for-medical-devices/) ### [How to comply with Health Canada Regulations for Medical Devices?](https://qualitysmartsolutions.com/blog/how-to-comply-with-health-canada-regulations-for-medical-devices/) Introduction: Manufacturing and selling medical devices in Canada can be a complex process and requires adherence to Health Canada’s ... [Read more](https://qualitysmartsolutions.com/blog/how-to-comply-with-health-canada-regulations-for-medical-devices/) March 22, 2023 [![Medical Device](https://qualitysmartsolutions.com/wp-content/uploads/2021/11/nurse-looking-at-medical-device-300x193.jpg)](https://qualitysmartsolutions.com/news/medical-device-license-mdl-renewals/) ### [Health Canada Medical Device License Renewals (MDL or MDEL) in 2023](https://qualitysmartsolutions.com/news/medical-device-license-mdl-renewals/) As a Canadian medical device license (MDL) holder, you are subject to an annual license renewal procedure. The renewal process ... [Read more](https://qualitysmartsolutions.com/news/medical-device-license-mdl-renewals/) March 22, 2023 [![Health Canada regulatory framework for Software as a Medical Device SAMD](https://qualitysmartsolutions.com/wp-content/uploads/2023/03/QssCLE-Social-Media-Creatives-Additional-91-300x300.webp)](https://qualitysmartsolutions.com/blog/mdel-mdl-approval-how-much-will-your-mdl-cost-in-2023/) ### [Understanding the Costs of MDL and MDEL Approvals](https://qualitysmartsolutions.com/blog/mdel-mdl-approval-how-much-will-your-mdl-cost-in-2023/) The price for an MDEL (Medical Device Establishment Licence) and MDL (Medical Device Licence) in Canada varies according to the ... [Read more](https://qualitysmartsolutions.com/blog/mdel-mdl-approval-how-much-will-your-mdl-cost-in-2023/) March 20, 2023 [![Medical Device Registration](https://qualitysmartsolutions.com/wp-content/uploads/2023/03/Screenshot-2023-03-16-110723-300x274.webp)](https://qualitysmartsolutions.com/news/fda-fees-for-medical-device-establishment-registration-in-2023/) ### [FDA Fees for Medical Device Establishment Registration in 2023](https://qualitysmartsolutions.com/news/fda-fees-for-medical-device-establishment-registration-in-2023/) The cost to register an FDA Medical Device Establishment is USD $6,493 for 2023. The FDA’s fiscal year 2023 ... [Read more](https://qualitysmartsolutions.com/news/fda-fees-for-medical-device-establishment-registration-in-2023/) March 16, 2023 [![Quality Import Service](https://qualitysmartsolutions.com/wp-content/uploads/2023/03/QSS-Images-2023-03-13T114759.172-e1756507151888-300x123.webp)](https://qualitysmartsolutions.com/blog/5-essential-tips-for-choosing-a-quality-import-service/) ### [How to Choose the Right Importer: 5 Essential Tips](https://qualitysmartsolutions.com/blog/5-essential-tips-for-choosing-a-quality-import-service/) Looking for a quality import service can be a daunting task, but with the right advice and tips, you can ... [Read more](https://qualitysmartsolutions.com/blog/5-essential-tips-for-choosing-a-quality-import-service/) March 13, 2023 [![Class 1 Medical Device](https://qualitysmartsolutions.com/wp-content/uploads/2023/03/QSS-Images-2023-03-08T155344.886-300x251.webp)](https://qualitysmartsolutions.com/blog/what-is-a-class-1-medical-device-everything-you-should-know/) ### [Understanding Class I Medical Devices Approval With Health Canada](https://qualitysmartsolutions.com/blog/what-is-a-class-1-medical-device-everything-you-should-know/) What are Class 1 Medical Devices? Class 1 medical devices are the lowest risk category of medical devices, as they ... [Read more](https://qualitysmartsolutions.com/blog/what-is-a-class-1-medical-device-everything-you-should-know/) March 8, 2023 [![Medical Devices Regulations for COVID-19 medical devices Importing & Sales Amendments](https://qualitysmartsolutions.com/wp-content/uploads/2023/03/QSS-Images-2023-03-07T111210.215-300x251.webp)](https://qualitysmartsolutions.com/news/mdr-amendments-covid-19-medical-devices-importing-sales/) ### [MDR Amendments COVID-19 Medical Devices Importing & Sales](https://qualitysmartsolutions.com/news/mdr-amendments-covid-19-medical-devices-importing-sales/) Background: Health Canada issued three interim orders to allow the importation and sale of medical devices used to diagnose, treat, ... [Read more](https://qualitysmartsolutions.com/news/mdr-amendments-covid-19-medical-devices-importing-sales/) March 7, 2023 [![Class 3 medical devices are subject to the highest level of scrutiny and require special attention when it comes to meeting their regulatory requirements. This article will discuss what it takes for Class 3 medical devices to meet these stringent requirements. Understand the Regulatory Requirements of Class 3 Medical Devices. Class 3 medical devices have the most stringent regulatory requirements when compared to other device classes. To ensure they meet the specific standards set by regulators, manufacturers must thoroughly understand what their obligations are and how to meet them. This includes understanding device labeling, conducting necessary preclinical tests, and designing appropriate clinical trials as well as obtaining marketing authorization from local and international agencies. With little room for error, a company must pay ample attention to meeting these strict regulations. Step-by-Step Guide for Regulatory Compliance Process. A step-by-step guide for Class 3 medical device manufacturers to prepare for and meet regulatory requirements is provided below: 1. Understand the local and international standards and regulations that apply to your product. 2. Perform risk assessments, identify hazards, and assess safety risks. 3. Develop appropriate device labeling information including instructions, warnings, indications, and contraindications. 4. Prepare preclinical tests related to the identified safety risks of the medical device. 5. Run clinical trials by applicable regulations and obtain relevant certification of efficacy, performance, or other features as necessary. 6. Submit marketing authorization applications to local or international agencies if required by applicable regulations or laws. 7. Develop post-marketing surveillance plans as may be needed going forward to ensure continued compliance with standards and regulations applicable to your device. Strategies to Reduce Cost and Time in Compliance Testing. There are strategies to reduce the cost and time associated with compliance testing. For example, the development of a standardized quality manual helps to streamline the process, by providing step-by-step protocols that must be met to achieve conformity with regulatory requirements. Leveraging tools like automated data collection can help bring costs down for conducting tests and checks, where testing has been pre-certified as meeting standard requirements. Additionally, engaging external compliance teams or consultants early in the process can help identify any potential problems quickly and provide advice on which steps are critical to addressing quality management issues. Assessing the Role of Third-Party Certifiers in Regulating these Devices. Third-party certifiers are an invaluable tool in the regulation of Class 3 medical devices. Not only do they allow manufacturers to have a comprehensive overview of the entire product development cycle and all its stages, but they also aid in certifying that requirements have been met as outlined by regulatory authorities. Additionally, they can provide valuable insights into which materials must be considered during the production process that may not necessarily be required by regulations, but would improve safety or efficacy. Ultimately, certification from third-party entities is an essential component for Class 3 medical devices to fully comply with applicable standards and regulations. Guidelines for manufacturers for Managing Risk and Adverse Events. The risk of adverse events is an ever-present reality for medical device manufacturers. Therefore, it is important to have a robust management system in place for risk and adverse event assessment, reporting, and monitoring to minimize the potential impact these may have on safety and efficacy. Manufacturers should clearly define criteria within product development plans to ensure appropriate assessments are taken during each product’s entire life cycle. This includes a systematic approach to suspending, withdrawing, or replacing devices deemed unsafe or ineffective due to adverse events. Additionally, manufacturers should be prepared to respond quickly and effectively whenever an adverse event or complaint is reported.](https://qualitysmartsolutions.com/wp-content/uploads/2023/02/QssCLE-Social-Media-Creatives-Additional-22-300x300.webp)](https://qualitysmartsolutions.com/blog/class-3-medical-devices-regulatory-requirements-unlocked/) ### [How to Navigate Regulatory Requirements for Class III Medical Devices](https://qualitysmartsolutions.com/blog/class-3-medical-devices-regulatory-requirements-unlocked/) Introduction: Class 3 medical devices are subject to the highest level of scrutiny and require special attention when it comes ... [Read more](https://qualitysmartsolutions.com/blog/class-3-medical-devices-regulatory-requirements-unlocked/) February 7, 2023 [![510K Premarket Notification](https://qualitysmartsolutions.com/wp-content/uploads/2023/01/QSS-Images-2023-01-23T143432.362-300x251.webp)](https://qualitysmartsolutions.com/blog/clearing-regulatory-hurdles-with-a-510k-premarket-notification/) ### [Clearing Regulatory Hurdles with a 510K Premarket Notification](https://qualitysmartsolutions.com/blog/clearing-regulatory-hurdles-with-a-510k-premarket-notification/) Submitting a 510K Premarket Notification is an essential step in the process of getting medical devices approved by the ... [Read more](https://qualitysmartsolutions.com/blog/clearing-regulatory-hurdles-with-a-510k-premarket-notification/) January 23, 2023 [![Health Canada Medical Device Regulations (MDL, MDEL, SaMD)](https://qualitysmartsolutions.com/wp-content/uploads/2022/11/iStock-1164846332-300x288.jpg)](https://qualitysmartsolutions.com/blog/health-canada-medical-device-regulations-mdl-mdel-samd/) ### [Explore Health Canada’s Medical Device Regulations (MDL, MDEL & SaMD)](https://qualitysmartsolutions.com/blog/health-canada-medical-device-regulations-mdl-mdel-samd/) Introduction: Medical devices are an important part of healthcare and play a critical role in the treatment of patients. Medical ... [Read more](https://qualitysmartsolutions.com/blog/health-canada-medical-device-regulations-mdl-mdel-samd/) December 8, 2022 [![Medical Device Classification in Canada](https://qualitysmartsolutions.com/wp-content/uploads/2022/03/canadian-medical-devices-300x193.jpg)](https://qualitysmartsolutions.com/blog/canadian-medical-device-classification-mdl-mdel/) ### [Understanding MDALL/MDEL & How It Transforms Your Business (MDL, MDALL, MDEL Listing)](https://qualitysmartsolutions.com/blog/canadian-medical-device-classification-mdl-mdel/) Navigating medical device regulations set by Health Canada can be challenging. However, knowing the correct classification of your medical device ... [Read more](https://qualitysmartsolutions.com/blog/canadian-medical-device-classification-mdl-mdel/) November 16, 2022 [![Medical Device License MDL MDEL SaMD](https://qualitysmartsolutions.com/wp-content/uploads/2022/11/CLE-qssBlogs-images-300x251.webp)](https://qualitysmartsolutions.com/blog/medical-device-license-mdl-mdel-samd-under-the-microscope/) ### [Medical Device License (MDL MDEL SaMD) Under the Microscope](https://qualitysmartsolutions.com/blog/medical-device-license-mdl-mdel-samd-under-the-microscope/) The Medical Device License is a legal document required to manufacture, sell, and distribute medical devices. The Medical Device Licence ... [Read more](https://qualitysmartsolutions.com/blog/medical-device-license-mdl-mdel-samd-under-the-microscope/) November 15, 2022 [![FDA Medical Device MDUFA Fees in 2023](https://qualitysmartsolutions.com/wp-content/uploads/2022/11/MDUFA-Fees-300x133.webp)](https://qualitysmartsolutions.com/news/fda-inside-scoop-medical-device-user-fees-mdufa-for-2023/) ### [Inside Scoop FDA Medical Device User Fees (MDUFA) for 2023](https://qualitysmartsolutions.com/news/fda-inside-scoop-medical-device-user-fees-mdufa-for-2023/) The FDA or U.S. Food and Drug Administration recently announced the Fiscal Year Medical Device User Fee (MDUFA) amendments. The ... [Read more](https://qualitysmartsolutions.com/news/fda-inside-scoop-medical-device-user-fees-mdufa-for-2023/) November 1, 2022 [![Medical Device License SaMD, MDL, MDEL](https://qualitysmartsolutions.com/wp-content/uploads/2022/08/medical-devices-canada-300x200.jpg)](https://qualitysmartsolutions.com/blog/inside-scoop-mdl-mdel-samd-medical-device-license-unlocked/) ### [Inside Scoop MDL VS MDEL & SAMD: Medical Device License Unlocked](https://qualitysmartsolutions.com/blog/inside-scoop-mdl-mdel-samd-medical-device-license-unlocked/) The Medical Device License is a legal document that is required for the manufacture, sale, and distribution of medical ... [Read more](https://qualitysmartsolutions.com/blog/inside-scoop-mdl-mdel-samd-medical-device-license-unlocked/) October 5, 2022 [![SaMD Software as a Medical Device](https://qualitysmartsolutions.com/wp-content/uploads/2022/08/iStock-1184804468-300x168.jpg)](https://qualitysmartsolutions.com/blog/how-does-the-fda-classify-software-as-a-medical-device-samd/) ### [How Does FDA Classify Software As A Medical Device (SaMD)?](https://qualitysmartsolutions.com/blog/how-does-the-fda-classify-software-as-a-medical-device-samd/) Nowadays almost all the facets of healthcare are well-equipped with the modern and latest technology tools, including software systems. ... [Read more](https://qualitysmartsolutions.com/blog/how-does-the-fda-classify-software-as-a-medical-device-samd/) September 15, 2022 [![Medical devices Standards EUA](https://qualitysmartsolutions.com/wp-content/uploads/2022/04/covid-19-medical-devices-300x193.jpg)](https://qualitysmartsolutions.com/news/eua-fda-transition-plan-for-medical-devices-in-2022/) ### [EUA FDA Transition Plan for Medical Devices in 2022](https://qualitysmartsolutions.com/news/eua-fda-transition-plan-for-medical-devices-in-2022/) In response to the COVID-19 public health emergency, FDA issued a declaration regarding the appropriateness of utilizing emergency use authorizations ... [Read more](https://qualitysmartsolutions.com/news/eua-fda-transition-plan-for-medical-devices-in-2022/) April 29, 2022 [![](https://qualitysmartsolutions.com/wp-content/uploads/2022/03/Health-Canada-drugs-300x193.jpg)](https://qualitysmartsolutions.com/news/health-canadas-annual-adjustment-of-fees-for-drugs-and-medical-devices/) ### [Health Canada’s Annual Adjustment of Fees for Drugs & Medical Devices](https://qualitysmartsolutions.com/news/health-canadas-annual-adjustment-of-fees-for-drugs-and-medical-devices/) On December 11, 2021, Health Canada issued a notice regarding the annual adjustment of fees for drugs and medical devices ... [Read more](https://qualitysmartsolutions.com/news/health-canadas-annual-adjustment-of-fees-for-drugs-and-medical-devices/) March 11, 2022 [![Medical Devices for COVID-19](https://qualitysmartsolutions.com/wp-content/uploads/2022/03/covid-19-medical-devices-300x193.jpg)](https://qualitysmartsolutions.com/news/interim-order-no-3-the-sale-of-medical-devices-for-covid-19-use/) ### [Interim Order No. 3 The Sale of Medical Devices for COVID-19 use](https://qualitysmartsolutions.com/news/interim-order-no-3-the-sale-of-medical-devices-for-covid-19-use/) Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (the third interim ... [Read more](https://qualitysmartsolutions.com/news/interim-order-no-3-the-sale-of-medical-devices-for-covid-19-use/) March 8, 2022 [![Medical Devices Development](https://qualitysmartsolutions.com/wp-content/uploads/2022/02/machine-learning-program-medical-devices-300x193.jpg)](https://qualitysmartsolutions.com/blog/10-principles-for-medical-device-development/) ### [Top 10 Fruitful Medical Device Development Principles](https://qualitysmartsolutions.com/blog/10-principles-for-medical-device-development/) Regulatory agencies across the globe, including the U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines ... [Read more](https://qualitysmartsolutions.com/blog/10-principles-for-medical-device-development/) February 9, 2022 [![](https://qualitysmartsolutions.com/wp-content/uploads/2022/02/Medical-Devices-Manufature-300x193.jpg)](https://qualitysmartsolutions.com/news/your-health-canada-emce-update-for-2022/) ### [Your Health Canada eMCE Update For 2022](https://qualitysmartsolutions.com/news/your-health-canada-emce-update-for-2022/) Manufacturers and companies exporting medical devices from Canada may be asked by foreign customers or foreign governments to supply certification ... [Read more](https://qualitysmartsolutions.com/news/your-health-canada-emce-update-for-2022/) February 5, 2022 [![](https://qualitysmartsolutions.com/wp-content/uploads/2021/10/medical-device-software-300x193.webp)](https://qualitysmartsolutions.com/blog/what-you-need-to-know-software-as-a-medical-device-samd/) ### [What You Need to Know – Software as a Medical Device (SaMD)](https://qualitysmartsolutions.com/blog/what-you-need-to-know-software-as-a-medical-device-samd/) The advancement of technology is rapidly progressing, and the evolution can be observed all around us. As cutting-edge technology becomes ... [Read more](https://qualitysmartsolutions.com/blog/what-you-need-to-know-software-as-a-medical-device-samd/) October 28, 2021 [![](https://qualitysmartsolutions.com/wp-content/uploads/2021/10/cannabis-Prescription-300x193.jpg)](https://qualitysmartsolutions.com/news/us-establishment-registration-renewals/) ### [US Establishment Registration Renewals](https://qualitysmartsolutions.com/news/us-establishment-registration-renewals/) It’s that time of year again! Any domestic and foreign establishments registered with US FDA must renew their registration annually ... [Read more](https://qualitysmartsolutions.com/news/us-establishment-registration-renewals/) October 11, 2021 [![](https://qualitysmartsolutions.com/wp-content/uploads/2021/09/medical-devices-300x193.webp)](https://qualitysmartsolutions.com/news/public-consultation-on-medical-devices-unique-device-identifier-initiative/) ### [Public Consultation on Medical Devices Unique Device Identifier Initiative](https://qualitysmartsolutions.com/news/public-consultation-on-medical-devices-unique-device-identifier-initiative/) On June 28, 2021, Health Canada opened a public consultation on a Unique Device Identification (UDI) system for medical devices ... [Read more](https://qualitysmartsolutions.com/news/public-consultation-on-medical-devices-unique-device-identifier-initiative/) September 14, 2021 [![](https://qualitysmartsolutions.com/wp-content/uploads/2021/08/Medical-Device-300x157.jpg)](https://qualitysmartsolutions.com/blog/mdsap-what-is-it-and-how-does-it-apply-to-my-medical-device/) ### [MDSAP: What Is It and How Does It Apply to my Medical Device?](https://qualitysmartsolutions.com/blog/mdsap-what-is-it-and-how-does-it-apply-to-my-medical-device/) Who Needs an MDSAP Certificate? Anyone looking to manufacture a Class II, III or IV medical device in Canada requires ... [Read more](https://qualitysmartsolutions.com/blog/mdsap-what-is-it-and-how-does-it-apply-to-my-medical-device/) August 20, 2021 [![](https://qualitysmartsolutions.com/wp-content/uploads/2021/07/clinical-trails-300x193.jpg)](https://qualitysmartsolutions.com/news/public-consultation-on-medical-devices-clinical-trials-modernization-initiative/) ### [Public Consultation on Medical Devices Clinical Trials Modernization Initiative](https://qualitysmartsolutions.com/news/public-consultation-on-medical-devices-clinical-trials-modernization-initiative/) Health Canada has published a consultation paper on proposed changes to the regulation and oversight of clinical trials for drug, ... [Read more](https://qualitysmartsolutions.com/news/public-consultation-on-medical-devices-clinical-trials-modernization-initiative/) July 16, 2021 [![](https://qualitysmartsolutions.com/wp-content/uploads/2021/07/review_licence-300x193.jpg)](https://qualitysmartsolutions.com/news/cancellation-of-mdels-for-non-compliance-with-annual-licence-review-requirements/) ### [Cancellation of MDELs for Non-Compliance with Annual Licence Review Requirements](https://qualitysmartsolutions.com/news/cancellation-of-mdels-for-non-compliance-with-annual-licence-review-requirements/) Cancellation of Medical Device Establishment Licence for A Non-compliance With Annual Licence Review Requirements On May 27, 2021 Health Canada ... [Read more](https://qualitysmartsolutions.com/news/cancellation-of-mdels-for-non-compliance-with-annual-licence-review-requirements/) July 2, 2021 [![Interim Order](https://qualitysmartsolutions.com/wp-content/uploads/2021/06/medical_equipment-300x193.jpg)](https://qualitysmartsolutions.com/news/interim-order-no-2-respecting-the-importation-and-sale-of-medical-devices-for-use-in-relation-to-covid-19/) ### [Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19](https://qualitysmartsolutions.com/news/interim-order-no-2-respecting-the-importation-and-sale-of-medical-devices-for-use-in-relation-to-covid-19/) As of March 1, 2021, Interim Order No. 2 replaces Interim Order No. 1 Respecting the importation and sale of ... [Read more](https://qualitysmartsolutions.com/news/interim-order-no-2-respecting-the-importation-and-sale-of-medical-devices-for-use-in-relation-to-covid-19/) June 15, 2021 [![](https://qualitysmartsolutions.com/wp-content/uploads/2025/04/covid-19-300x138.jpg)](https://qualitysmartsolutions.com/blog/ensuring-predictability-for-interim-orders-relating-to-covid-19/) ### [Ensuring Predictability for Interim Orders Relating to COVID-19](https://qualitysmartsolutions.com/blog/ensuring-predictability-for-interim-orders-relating-to-covid-19/) Health Canada recently published an additional notice regarding all interim orders relating to COVID-19 and Medical Devices. This notice is ... [Read more](https://qualitysmartsolutions.com/blog/ensuring-predictability-for-interim-orders-relating-to-covid-19/) December 15, 2020 [![](https://qualitysmartsolutions.com/wp-content/uploads/2020/09/Non-Medical-Masks-or-Face-Coverings-300x157.jpg)](https://qualitysmartsolutions.com/blog/regulatory-considerations-for-non-medical-masks-or-face-coverings/) ### [Regulatory Considerations for Non-Medical Masks or Face Coverings](https://qualitysmartsolutions.com/blog/regulatory-considerations-for-non-medical-masks-or-face-coverings/) Earlier this summer, Health Canada provided a notice to industry on the regulatory considerations for non-medical masks or face coverings, ... [Read more](https://qualitysmartsolutions.com/blog/regulatory-considerations-for-non-medical-masks-or-face-coverings/) September 13, 2020 [![Illegal Marketing of Drugs and Medical Devices in Canada](https://qualitysmartsolutions.com/wp-content/uploads/2020/01/Drugs-and-Medical-Devices-in-Canada-300x157.jpg)](https://qualitysmartsolutions.com/blog/illegal-marketing-of-drugs-and-medical-devices-in-canada-2/) ### [Illegal Marketing of Drugs and Medical Devices in Canada](https://qualitysmartsolutions.com/blog/illegal-marketing-of-drugs-and-medical-devices-in-canada-2/) Health Canada is not only the national regulatory authority for issuing health product marketing authorizations, but it also oversees and ... [Read more](https://qualitysmartsolutions.com/blog/illegal-marketing-of-drugs-and-medical-devices-in-canada-2/) January 20, 2020 We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Melatonin Information [Skip to content](https://qualitysmartsolutions.com/topic/melatonin#content) # Melatonin Search Search \[searchwp\_form id=1\] \[blog\_list\] [![Health Canada Prescription Drug List amendment restricting melatonin to prescription-only for pediatric use in Canada](https://qualitysmartsolutions.com/wp-content/uploads/2026/06/pediatric-melatonin-prescription-drug-Canada-300x157.jpg)](https://qualitysmartsolutions.com/news/health-canada-amends-prescription-drug-list-to-require-a-prescription-for-pediatric-melatonin-use/) ### [Health Canada Amends Prescription Drug List to Require a Prescription for Pediatric Melatonin Use](https://qualitysmartsolutions.com/news/health-canada-amends-prescription-drug-list-to-require-a-prescription-for-pediatric-melatonin-use/) Health Canada has amended the Prescription Drug List (PDL) to require a prescription for all sleep-related use of melatonin in ... [Read more](https://qualitysmartsolutions.com/news/health-canada-amends-prescription-drug-list-to-require-a-prescription-for-pediatric-melatonin-use/) June 10, 2026 We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Natural Health Updates [Skip to content](https://qualitysmartsolutions.com/topic/natural-health-products#content) # Natural Health Products Search Search \[searchwp\_form id=1\] \[blog\_list\] [![Health Canada Prescription Drug List amendment restricting melatonin to prescription-only for pediatric use in Canada](https://qualitysmartsolutions.com/wp-content/uploads/2026/06/pediatric-melatonin-prescription-drug-Canada-300x157.jpg)](https://qualitysmartsolutions.com/news/health-canada-amends-prescription-drug-list-to-require-a-prescription-for-pediatric-melatonin-use/) ### [Health Canada Amends Prescription Drug List to Require a Prescription for Pediatric Melatonin Use](https://qualitysmartsolutions.com/news/health-canada-amends-prescription-drug-list-to-require-a-prescription-for-pediatric-melatonin-use/) Health Canada has amended the Prescription Drug List (PDL) to require a prescription for all sleep-related use of melatonin in ... [Read more](https://qualitysmartsolutions.com/news/health-canada-amends-prescription-drug-list-to-require-a-prescription-for-pediatric-melatonin-use/) June 10, 2026 We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Natural Health Products Guide [Skip to content](https://qualitysmartsolutions.com/topic/natural-health-products-nhps#content) # Natural Health Products (NHPs) Search Search \[searchwp\_form id=1\] \[blog\_list\] [![](https://qualitysmartsolutions.com/wp-content/uploads/2025/02/naturalproductsexpowest-rgb.webp)](https://qualitysmartsolutions.com/events/natural-products-expo-west-2025/) ### [Natural Products Expo West 2025](https://qualitysmartsolutions.com/events/natural-products-expo-west-2025/) Join Quality Smart Solutions at Natural Products Expo West 2025, the top trade show for the natural, organic, and healthy ... [Read more](https://qualitysmartsolutions.com/events/natural-products-expo-west-2025/) February 7, 2025 [![NPN license](https://qualitysmartsolutions.com/wp-content/uploads/2024/10/nhp-suppliments-300x181.jpg)](https://qualitysmartsolutions.com/blog/how-to-obtain-an-npn-license-for-your-natural-health-product-in-canada/) ### [How to Obtain an NPN License for Your Natural Health Product in Canada](https://qualitysmartsolutions.com/blog/how-to-obtain-an-npn-license-for-your-natural-health-product-in-canada/) When it comes to selling natural health products (NHPs) in Canada, securing an NPN license is your ticket to success. ... [Read more](https://qualitysmartsolutions.com/blog/how-to-obtain-an-npn-license-for-your-natural-health-product-in-canada/) September 19, 2023 [![We'll demystify the terminology, provide insider tips, and equip you with all the knowledge you need to navigate the Health Canada NPN process confidently.](https://qualitysmartsolutions.com/wp-content/uploads/2023/08/QssCLE-Social-Media-Creatives-Additional-2023-08-01T133233.887-300x300.webp)](https://qualitysmartsolutions.com/blog/navigating-the-health-canada-npn-process-a-step-by-step-guide/) ### [How to Secure a Natural Product Number in Canada](https://qualitysmartsolutions.com/blog/navigating-the-health-canada-npn-process-a-step-by-step-guide/) Are you a health and wellness entrepreneur looking to bring your products to the Canadian market? Navigating the Health Canada ... [Read more](https://qualitysmartsolutions.com/blog/navigating-the-health-canada-npn-process-a-step-by-step-guide/) August 1, 2023 [![Health Canada released a proposal with a massive financial impact for NHP business owners and cost recovery fees.](https://qualitysmartsolutions.com/wp-content/uploads/2023/05/table-1-300x251.webp)](https://qualitysmartsolutions.com/blog/emergency-alert-nnhpd-proposed-fees-may-lead-to-business-closures/) ### [Emergency Alert: NNHPD proposed fees may lead to business closures](https://qualitysmartsolutions.com/blog/emergency-alert-nnhpd-proposed-fees-may-lead-to-business-closures/) Health Canada has the authority to set and charge health product fees under the Food and Drugs Act (FDA). On ... [Read more](https://qualitysmartsolutions.com/blog/emergency-alert-nnhpd-proposed-fees-may-lead-to-business-closures/) May 16, 2023 [![Quality Import Service](https://qualitysmartsolutions.com/wp-content/uploads/2023/03/QSS-Images-2023-03-13T114759.172-e1756507151888-300x123.webp)](https://qualitysmartsolutions.com/blog/5-essential-tips-for-choosing-a-quality-import-service/) ### [How to Choose the Right Importer: 5 Essential Tips](https://qualitysmartsolutions.com/blog/5-essential-tips-for-choosing-a-quality-import-service/) Looking for a quality import service can be a daunting task, but with the right advice and tips, you can ... [Read more](https://qualitysmartsolutions.com/blog/5-essential-tips-for-choosing-a-quality-import-service/) March 13, 2023 [![Natural Health Product Regulations](https://qualitysmartsolutions.com/wp-content/uploads/2022/10/iStock-1354098185-300x259.jpg)](https://qualitysmartsolutions.com/blog/top-natural-health-product-regulations-in-canada/) ### [Key Natural Health Product Regulations Canadian Businesses Should Know](https://qualitysmartsolutions.com/blog/top-natural-health-product-regulations-in-canada/) The Canadian government has a set of regulations in place for natural health products (NHPs). These regulations help to ensure ... [Read more](https://qualitysmartsolutions.com/blog/top-natural-health-product-regulations-in-canada/) October 18, 2022 [![Screenshot of Health Canada's NHPID and NPN search pages](https://qualitysmartsolutions.com/wp-content/uploads/2022/08/Natural-Health-Products-Ingredients-Database-300x157.jpg)](https://qualitysmartsolutions.com/blog/nhpid-and-npn-what-you-need-to-know/) ### [NHPID and NPN: 6 Key Things Businesses Should Know](https://qualitysmartsolutions.com/blog/nhpid-and-npn-what-you-need-to-know/) If you’re selling natural health products in Canada, understanding NHPID and NPN is essential. These tools from Health Canada determine ... [Read more](https://qualitysmartsolutions.com/blog/nhpid-and-npn-what-you-need-to-know/) August 29, 2022 [![Natural Health Products NHP NPN](https://qualitysmartsolutions.com/wp-content/uploads/2022/08/iStock-878852718-300x200.jpg)](https://qualitysmartsolutions.com/blog/natural-health-products-nhp-npn-19-questions-to-ask/) ### [Natural Health Products (NHP/NPN) Panel Top 19 Questions Answered](https://qualitysmartsolutions.com/blog/natural-health-products-nhp-npn-19-questions-to-ask/) 1\. What is the NHP Licensing Process/what is needed for it? This process involves the submission of a product license ... [Read more](https://qualitysmartsolutions.com/blog/natural-health-products-nhp-npn-19-questions-to-ask/) August 25, 2022 [![Natural Health Products that contain CBD](https://qualitysmartsolutions.com/wp-content/uploads/2022/08/CLEQSS-Blog-Images-4-300x300.webp)](https://qualitysmartsolutions.com/news/regulatory-market-landscapes-of-cbd-as-a-nhp/) ### [Regulatory & Market Landscapes of CBD as a NHP](https://qualitysmartsolutions.com/news/regulatory-market-landscapes-of-cbd-as-a-nhp/) https://youtu.be/veCBMkYUWEU Market Analysis and Overview of CPG Market: Will CBD Products be considered an NHP? The consumer packaged goods (CPG) ... [Read more](https://qualitysmartsolutions.com/news/regulatory-market-landscapes-of-cbd-as-a-nhp/) August 5, 2022 [![NHP Labelling](https://qualitysmartsolutions.com/wp-content/uploads/2022/04/dietary-supplements-300x193.jpg)](https://qualitysmartsolutions.com/blog/dietary-supplement-labeling-vs-nhp-labeling-in-north-america/) ### [Learn how to differentiate Dietary Supplement vs NHP Labeling](https://qualitysmartsolutions.com/blog/dietary-supplement-labeling-vs-nhp-labeling-in-north-america/) Introduction Dietary supplements in the USA are very similar to natural health products (NHP regulations) in Canada and many products ... [Read more](https://qualitysmartsolutions.com/blog/dietary-supplement-labeling-vs-nhp-labeling-in-north-america/) April 18, 2022 [![NPN](https://qualitysmartsolutions.com/wp-content/uploads/2022/03/Natural-Health-Products-Number-300x193.jpg)](https://qualitysmartsolutions.com/blog/top-5-tips-to-successfully-secure-your-npn-number/) ### [Practical Tips for Getting an NPN Number in Canada](https://qualitysmartsolutions.com/blog/top-5-tips-to-successfully-secure-your-npn-number/) Top 5 Tips to Successfully Secure an NPN Number In order to sell a Natural Health Product (NHP) in Canada ... [Read more](https://qualitysmartsolutions.com/blog/top-5-tips-to-successfully-secure-your-npn-number/) March 10, 2022 [![Natural Health Product](https://qualitysmartsolutions.com/wp-content/uploads/2022/02/natural-health-products-regulations-300x193.jpg)](https://qualitysmartsolutions.com/blog/overview-of-quality-of-natural-health-products-guide/) ### [Natural Health Products Quality Characterization Guide for 2022](https://qualitysmartsolutions.com/blog/overview-of-quality-of-natural-health-products-guide/) Natural Health Products have different characterization, identification, quantification, and purity standards that you should know about to ensure the quality ... [Read more](https://qualitysmartsolutions.com/blog/overview-of-quality-of-natural-health-products-guide/) February 14, 2022 [![Therapeutic Claim, Cosmetic, NHP](https://qualitysmartsolutions.com/wp-content/uploads/2022/01/Therapeutic-Claim-300x193.jpg)](https://qualitysmartsolutions.com/blog/therapeutic-claim-vs-non-therapeutic-claim-whats-the-difference-and-when-can-i-use-them/) ### [Therapeutic vs. Non-Therapeutic Claims Classification Guide](https://qualitysmartsolutions.com/blog/therapeutic-claim-vs-non-therapeutic-claim-whats-the-difference-and-when-can-i-use-them/) What is a claim? A claim is a representation for sale. It can be presented as “a word, a sentence, ... [Read more](https://qualitysmartsolutions.com/blog/therapeutic-claim-vs-non-therapeutic-claim-whats-the-difference-and-when-can-i-use-them/) January 24, 2022 [![Product Licence Application](https://qualitysmartsolutions.com/wp-content/uploads/2022/01/Natural-Health-Products-Licence-300x193.jpg)](https://qualitysmartsolutions.com/blog/components-of-a-class-iii-nhp-product-licence-application/) ### [Top Components of your Class III NHP PLA](https://qualitysmartsolutions.com/blog/components-of-a-class-iii-nhp-product-licence-application/) All Natural Health Products (NHPs) sold in Canada are subject to the Natural Health Products Regulations (NHPR). Natural Health Products ... [Read more](https://qualitysmartsolutions.com/blog/components-of-a-class-iii-nhp-product-licence-application/) January 12, 2022 [![Natural Health Products](https://qualitysmartsolutions.com/wp-content/uploads/2022/01/Natural-Health-Products-300x193.jpg)](https://qualitysmartsolutions.com/news/update-on-performance-standards-for-nhp-applications/) ### [Update on Performance Standards for NHP Applications](https://qualitysmartsolutions.com/news/update-on-performance-standards-for-nhp-applications/) Summary of Health Canada Licensing and Update Reports Product Licensing A combined 1390/5045 (28%) of NHP product license application submissions ... [Read more](https://qualitysmartsolutions.com/news/update-on-performance-standards-for-nhp-applications/) January 7, 2022 [![Natural Health Product Regulations](https://qualitysmartsolutions.com/wp-content/uploads/2021/12/Medical-Mushroom-300x193.jpg)](https://qualitysmartsolutions.com/blog/how-to-legally-sell-medicinal-mushrooms-in-canada/) ### [How to Legally Sell Medicinal Mushrooms in Canada?](https://qualitysmartsolutions.com/blog/how-to-legally-sell-medicinal-mushrooms-in-canada/) Medicinal Mushrooms in powder, capsule or liquid form can be licensed as Natural Health Product (NHP) in Canada. To sell ... [Read more](https://qualitysmartsolutions.com/blog/how-to-legally-sell-medicinal-mushrooms-in-canada/) December 24, 2021 [![NPN, Ingredient Database](https://qualitysmartsolutions.com/wp-content/uploads/2021/12/greens-and-protein-products-300x193.jpg)](https://qualitysmartsolutions.com/blog/greens-and-proteins-food-or-nhp/) ### [Greens and Proteins – Food or NHP?](https://qualitysmartsolutions.com/blog/greens-and-proteins-food-or-nhp/) The classification of Foods and Natural Health Products (NHPs) can be considered difficult, grey, and convoluted. Sometimes even comes down ... [Read more](https://qualitysmartsolutions.com/blog/greens-and-proteins-food-or-nhp/) December 14, 2021 [![NPN Application](https://qualitysmartsolutions.com/wp-content/uploads/2021/11/npn-number-300x193.jpg)](https://qualitysmartsolutions.com/blog/what-to-expect-after-submitting-an-npn-application/) ### [What to Expect After Submitting Your NPN Application](https://qualitysmartsolutions.com/blog/what-to-expect-after-submitting-an-npn-application/) What to Expect After Submitting an NPN Application In order to sell a Natural Health Product (NHP) in Canada, you ... [Read more](https://qualitysmartsolutions.com/blog/what-to-expect-after-submitting-an-npn-application/) November 19, 2021 [![](https://qualitysmartsolutions.com/wp-content/uploads/2021/10/Hemp-Oil-and-Products-300x193.jpg)](https://qualitysmartsolutions.com/blog/how-to-sell-hemp-oil-health-products-in-canada/) ### [How to sell Hemp Oil Health Products in Canada?](https://qualitysmartsolutions.com/blog/how-to-sell-hemp-oil-health-products-in-canada/) What is Hemp Seed Oil categorized as in Canada? In Canada, Hemp (Canna Sativa) seed oil can be categorized as ... [Read more](https://qualitysmartsolutions.com/blog/how-to-sell-hemp-oil-health-products-in-canada/) October 13, 2021 [![](https://qualitysmartsolutions.com/wp-content/uploads/2021/10/vitamin-d-gel-capsules-300x193.webp)](https://qualitysmartsolutions.com/news/vitamin-d-limits-for-nhps-are-now-higher/) ### [Vitamin D Limits for NHPs are now Higher](https://qualitysmartsolutions.com/news/vitamin-d-limits-for-nhps-are-now-higher/) The “Sunshine” vitamin, Vitamin D, Vitamin D3 or Vitamin D2 as it is more commonly known. The term “sunshine” was ... [Read more](https://qualitysmartsolutions.com/news/vitamin-d-limits-for-nhps-are-now-higher/) October 4, 2021 [![](https://qualitysmartsolutions.com/wp-content/uploads/2021/09/canna-300x193.webp)](https://qualitysmartsolutions.com/blog/summary-of-guidelines-for-advertising-health-products/) ### [Summary of Guidelines for Advertising Health Products](https://qualitysmartsolutions.com/blog/summary-of-guidelines-for-advertising-health-products/) Advertising is something almost all people experience and view daily. Yet, it can be challenging to navigate this space as ... [Read more](https://qualitysmartsolutions.com/blog/summary-of-guidelines-for-advertising-health-products/) September 21, 2021 [![](https://qualitysmartsolutions.com/wp-content/uploads/2021/09/Untitled-1-2-300x193.jpg)](https://qualitysmartsolutions.com/news/important-notice-regarding-the-transition-of-covid-19-site-licenses/) ### [Important Notice Regarding the Transition of COVID-19 Site Licenses](https://qualitysmartsolutions.com/news/important-notice-regarding-the-transition-of-covid-19-site-licenses/) In March 2020, Health Canada introduced interim measures to expedite the issuance of site licences for alcohol-based hand sanitizers, to ... [Read more](https://qualitysmartsolutions.com/news/important-notice-regarding-the-transition-of-covid-19-site-licenses/) September 1, 2021 [![](https://qualitysmartsolutions.com/wp-content/uploads/2021/09/tabs-300x193.jpg)](https://qualitysmartsolutions.com/news/consultation-period-extension-proposal-to-improve-natural-health-product-labelling/) ### [Consultation Period Extension: Proposal to Improve Natural Health Product Labelling](https://qualitysmartsolutions.com/news/consultation-period-extension-proposal-to-improve-natural-health-product-labelling/) On June 26, 2021, Health Canada launched a consultation on a proposal to improve natural health product labelling. Health Canada ... [Read more](https://qualitysmartsolutions.com/news/consultation-period-extension-proposal-to-improve-natural-health-product-labelling/) August 16, 2021 [![](https://qualitysmartsolutions.com/wp-content/uploads/2021/08/Untitled-1-300x193.jpg)](https://qualitysmartsolutions.com/news/proposal-to-improve-natural-health-product-labelling/) ### [Proposal to Improve Natural Health Product Labelling](https://qualitysmartsolutions.com/news/proposal-to-improve-natural-health-product-labelling/) On June 25, 2021, Health Canada published a news release that announced proposed changes to the Natural Health Products Regulations. ... [Read more](https://qualitysmartsolutions.com/news/proposal-to-improve-natural-health-product-labelling/) August 13, 2021 [![](https://qualitysmartsolutions.com/wp-content/uploads/2021/07/nhp-label-300x193.jpg)](https://qualitysmartsolutions.com/blog/the-components-of-an-nhp-label/) ### [What are the components of an NHP Label in 2023?](https://qualitysmartsolutions.com/blog/the-components-of-an-nhp-label/) The product label is something we all look at in our daily lives, but not everyone is well equipped with ... [Read more](https://qualitysmartsolutions.com/blog/the-components-of-an-nhp-label/) July 27, 2021 [![](https://qualitysmartsolutions.com/wp-content/uploads/2021/09/dietary-supplements-amazon-300x193.jpg)](https://qualitysmartsolutions.com/blog/how-to-sell-a-dietary-supplement-nhp-on-amazon-ca-or-online-in-canada/) ### [How to sell a Dietary Supplement NHP on Amazon.ca (or online in Canada)](https://qualitysmartsolutions.com/blog/how-to-sell-a-dietary-supplement-nhp-on-amazon-ca-or-online-in-canada/) How to Sell Dietary Supplements or NHPs on Amazon or Other Online Platforms in Canada? What is an NHP? In ... [Read more](https://qualitysmartsolutions.com/blog/how-to-sell-a-dietary-supplement-nhp-on-amazon-ca-or-online-in-canada/) July 13, 2021 [![](https://qualitysmartsolutions.com/wp-content/uploads/2021/06/nhp-products-300x151.jpg)](https://qualitysmartsolutions.com/blog/why-you-should-consider-a-third-party-nhp-importer-of-record/) ### [Why You Should Consider a Third-Party NHP Importer of Record?](https://qualitysmartsolutions.com/blog/why-you-should-consider-a-third-party-nhp-importer-of-record/) Natural Health Products (NHPs) are regulated by Health Canada under the authority of the Food and Drugs Act and the Natural ... [Read more](https://qualitysmartsolutions.com/blog/why-you-should-consider-a-third-party-nhp-importer-of-record/) June 3, 2021 [![](https://qualitysmartsolutions.com/wp-content/uploads/2021/05/nhp_covid-300x200.jpg)](https://qualitysmartsolutions.com/news/performance-standards-for-nhp-applications/) ### [Performance Standards for NHP Applications](https://qualitysmartsolutions.com/news/performance-standards-for-nhp-applications/) The coronavirus-19 (COVID-19) pandemic has had a long-lasting effect on many of the processes done in business and everyday life. ... [Read more](https://qualitysmartsolutions.com/news/performance-standards-for-nhp-applications/) May 12, 2021 [![NNHPD monographs guide for Class I, II and III NHP applications](https://qualitysmartsolutions.com/wp-content/uploads/2021/03/nnhpd-monographs-300x157.jpg)](https://qualitysmartsolutions.com/blog/nnhpd-monographs-class-i-ii-iii/) ### [NNHPD Monographs: Difference Between Class I, II and III Applications](https://qualitysmartsolutions.com/blog/nnhpd-monographs-class-i-ii-iii/) Introduction Have you ever wondered which Natural Health Product (NHP) application class your product belongs to? This is a question ... [Read more](https://qualitysmartsolutions.com/blog/nnhpd-monographs-class-i-ii-iii/) March 1, 2021 [![](https://qualitysmartsolutions.com/wp-content/uploads/2020/03/QA-hand-sanitizer-300x193.jpg)](https://qualitysmartsolutions.com/blog/qa-selling-hand-sanitizers-in-canada-during-covid-19-pandemic/) ### [Q&A: Selling Hand Sanitizers in Canada](https://qualitysmartsolutions.com/blog/qa-selling-hand-sanitizers-in-canada-during-covid-19-pandemic/) With the need for hand sanitizers significantly increasing for healthcare personnel and individuals during the current COVID-19 pandemic do help ... [Read more](https://qualitysmartsolutions.com/blog/qa-selling-hand-sanitizers-in-canada-during-covid-19-pandemic/) March 22, 2020 [![](https://qualitysmartsolutions.com/wp-content/uploads/2020/01/adverse-reactions-300x193.jpg)](https://qualitysmartsolutions.com/blog/reporting-adverse-reactions-to-marketed-health-products/) ### [Reporting Adverse Reactions to Marketed Health Products](https://qualitysmartsolutions.com/blog/reporting-adverse-reactions-to-marketed-health-products/) All marketed drugs and health products have benefits and risks. All health products are carefully evaluated before they are licensed ... [Read more](https://qualitysmartsolutions.com/blog/reporting-adverse-reactions-to-marketed-health-products/) January 31, 2020 [![](https://qualitysmartsolutions.com/wp-content/uploads/2020/01/Consumer-Advertising-of-Health-Products-300x157.jpg)](https://qualitysmartsolutions.com/blog/consumer-advertising-of-health-products/) ### [Consumer Advertising of Health Products](https://qualitysmartsolutions.com/blog/consumer-advertising-of-health-products/) In continuation to the last article on Canadian legislations and requirements regarding the marketing of drugs and medical devices, this ... [Read more](https://qualitysmartsolutions.com/blog/consumer-advertising-of-health-products/) January 22, 2020 [![](https://qualitysmartsolutions.com/wp-content/uploads/2021/07/nhp-licence-300x193.jpg)](https://qualitysmartsolutions.com/blog/natural-health-product-brand-name-guidance/) ### [Natural Health Product Brand Name Guidance](https://qualitysmartsolutions.com/blog/natural-health-product-brand-name-guidance/) Natural Health Product Brand Name Guidance Brand names are an important part of your marketing strategy, but as many of ... [Read more](https://qualitysmartsolutions.com/blog/natural-health-product-brand-name-guidance/) October 10, 2018 [![Essential oils classification as cosmetics or NHPs in Canada](https://qualitysmartsolutions.com/wp-content/uploads/2018/08/essential-oils-300x157.jpg)](https://qualitysmartsolutions.com/blog/essentials-oils-cosmetic-or-nhp/) ### [Essential Oils Compliance: Navigating NHP vs. Cosmetic Categories](https://qualitysmartsolutions.com/blog/essentials-oils-cosmetic-or-nhp/) Unsure how your essential oils fit into Health Canada’s rules? The difference between a cosmetic and a Natural Health Product ... [Read more](https://qualitysmartsolutions.com/blog/essentials-oils-cosmetic-or-nhp/) August 28, 2018 [![Distinguishing Between a Natural Health Product and a Supplemented Food](https://qualitysmartsolutions.com/wp-content/uploads/2018/07/Food-or-NHP-300x157.jpg)](https://qualitysmartsolutions.com/blog/food-or-nhp-distinguishing-between-a-natural-health-product-and-a-supplemented-food/) ### [Food or NHP: Distinguishing Between a Natural Health Product and a Supplemented Food](https://qualitysmartsolutions.com/blog/food-or-nhp-distinguishing-between-a-natural-health-product-and-a-supplemented-food/) Supplemented foods and natural health products (NHPs) can sometimes pose challenges when trying to determine the correct regulatory pathway to ... [Read more](https://qualitysmartsolutions.com/blog/food-or-nhp-distinguishing-between-a-natural-health-product-and-a-supplemented-food/) July 26, 2018 [![](https://qualitysmartsolutions.com/wp-content/uploads/2018/06/nutritution-fact-300x193.jpg)](https://qualitysmartsolutions.com/blog/plain-language-labelling-for-otcs-nhps/) ### [Plain Language Labelling for OTCs & NHPs](https://qualitysmartsolutions.com/blog/plain-language-labelling-for-otcs-nhps/) Health Canada implemented the Plain Language Labelling (PLL) initiative to help make the labels for non-prescription health products easier to ... [Read more](https://qualitysmartsolutions.com/blog/plain-language-labelling-for-otcs-nhps/) June 2, 2018 [![](https://qualitysmartsolutions.com/wp-content/uploads/2018/04/npn-300x193.jpg)](https://qualitysmartsolutions.com/blog/imminent-changes-to-the-current-canada-natural-health-product-npn-licensing-timelines/) ### [Imminent Changes to the Current Canada Natural Health Product (NPN) Licensing timelines](https://qualitysmartsolutions.com/blog/imminent-changes-to-the-current-canada-natural-health-product-npn-licensing-timelines/) In October 2014, the Natural and Non-prescription Health Products released a policy to manage the overall application review process. It ... [Read more](https://qualitysmartsolutions.com/blog/imminent-changes-to-the-current-canada-natural-health-product-npn-licensing-timelines/) April 30, 2018 [![MDEL medical device establishment licence listing](https://qualitysmartsolutions.com/wp-content/uploads/2021/01/why_us-300x200.jpg)](https://qualitysmartsolutions.com/blog/business-considerations-when-applying-for-a-natural-product-number-npn/) ### [What Every Business Should Know About NPN Applications](https://qualitysmartsolutions.com/blog/business-considerations-when-applying-for-a-natural-product-number-npn/) Just a little background information first before I talk about the business aspect of capitalizing on your NPN. NPN stands ... [Read more](https://qualitysmartsolutions.com/blog/business-considerations-when-applying-for-a-natural-product-number-npn/) February 19, 2018 [![](https://qualitysmartsolutions.com/wp-content/uploads/2021/01/iStock-473071518-300x196.jpg)](https://qualitysmartsolutions.com/blog/a-new-nhpd-coming-soon/) ### [A New NHPD Ingredient Database Monograph Coming Soon?](https://qualitysmartsolutions.com/blog/a-new-nhpd-coming-soon/) Health Canada recently announced their initiative to modernize the regulatory framework for health products and foods. This is required due ... [Read more](https://qualitysmartsolutions.com/blog/a-new-nhpd-coming-soon/) March 1, 2014 We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## NHP Compliance Updates [Skip to content](https://qualitysmartsolutions.com/topic/nhp-compliance#content) # NHP Compliance Search Search \[searchwp\_form id=1\] \[blog\_list\] [![Health Canada Prescription Drug List amendment restricting melatonin to prescription-only for pediatric use in Canada](https://qualitysmartsolutions.com/wp-content/uploads/2026/06/pediatric-melatonin-prescription-drug-Canada-300x157.jpg)](https://qualitysmartsolutions.com/news/health-canada-amends-prescription-drug-list-to-require-a-prescription-for-pediatric-melatonin-use/) ### [Health Canada Amends Prescription Drug List to Require a Prescription for Pediatric Melatonin Use](https://qualitysmartsolutions.com/news/health-canada-amends-prescription-drug-list-to-require-a-prescription-for-pediatric-melatonin-use/) Health Canada has amended the Prescription Drug List (PDL) to require a prescription for all sleep-related use of melatonin in ... [Read more](https://qualitysmartsolutions.com/news/health-canada-amends-prescription-drug-list-to-require-a-prescription-for-pediatric-melatonin-use/) June 10, 2026 We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## NPN Application Guide [Skip to content](https://qualitysmartsolutions.com/topic/npn-application#content) # NPN Application Search Search \[searchwp\_form id=1\] \[blog\_list\] [![We'll demystify the terminology, provide insider tips, and equip you with all the knowledge you need to navigate the Health Canada NPN process confidently.](https://qualitysmartsolutions.com/wp-content/uploads/2023/08/QssCLE-Social-Media-Creatives-Additional-2023-08-01T133233.887-300x300.webp)](https://qualitysmartsolutions.com/blog/navigating-the-health-canada-npn-process-a-step-by-step-guide/) ### [How to Secure a Natural Product Number in Canada](https://qualitysmartsolutions.com/blog/navigating-the-health-canada-npn-process-a-step-by-step-guide/) Are you a health and wellness entrepreneur looking to bring your products to the Canadian market? Navigating the Health Canada ... [Read more](https://qualitysmartsolutions.com/blog/navigating-the-health-canada-npn-process-a-step-by-step-guide/) August 1, 2023 [![NPN Number System](https://qualitysmartsolutions.com/wp-content/uploads/2023/06/QssCLE-Social-Media-Creatives-Additional-2023-06-14T134939.233-300x300.webp)](https://qualitysmartsolutions.com/blog/navigating-health-canadas-npn-number-system-a-guide-for-business-owners/) ### [Navigating Health Canada’s NPN Number System: A Guide for Business Owners](https://qualitysmartsolutions.com/blog/navigating-health-canadas-npn-number-system-a-guide-for-business-owners/) Are you a business owner in the health and wellness industry? If so, you’re likely familiar with Health Canada’s Natural ... [Read more](https://qualitysmartsolutions.com/blog/navigating-health-canadas-npn-number-system-a-guide-for-business-owners/) June 14, 2023 [![Natural Health Product Regulations](https://qualitysmartsolutions.com/wp-content/uploads/2022/10/iStock-1354098185-300x259.jpg)](https://qualitysmartsolutions.com/blog/top-natural-health-product-regulations-in-canada/) ### [Key Natural Health Product Regulations Canadian Businesses Should Know](https://qualitysmartsolutions.com/blog/top-natural-health-product-regulations-in-canada/) The Canadian government has a set of regulations in place for natural health products (NHPs). These regulations help to ensure ... [Read more](https://qualitysmartsolutions.com/blog/top-natural-health-product-regulations-in-canada/) October 18, 2022 [![NPN Application](https://qualitysmartsolutions.com/wp-content/uploads/2021/11/npn-number-300x193.jpg)](https://qualitysmartsolutions.com/blog/what-to-expect-after-submitting-an-npn-application/) ### [What to Expect After Submitting Your NPN Application](https://qualitysmartsolutions.com/blog/what-to-expect-after-submitting-an-npn-application/) What to Expect After Submitting an NPN Application In order to sell a Natural Health Product (NHP) in Canada, you ... [Read more](https://qualitysmartsolutions.com/blog/what-to-expect-after-submitting-an-npn-application/) November 19, 2021 We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## OTC Drugs Overview [Skip to content](https://qualitysmartsolutions.com/topic/otc-drugs#content) # OTC Drugs Search Search \[searchwp\_form id=1\] \[blog\_list\] [![Health Canada fees 2026 overview for medical devices drugs and cannabis](https://qualitysmartsolutions.com/wp-content/uploads/2026/01/health-canada-2026-news-300x157.jpg)](https://qualitysmartsolutions.com/news/what-you-need-to-know-about-health-canada-fees-in-2026/) ### [Health Canada Fees 2026: Updates for Devices, Drugs & Cannabis](https://qualitysmartsolutions.com/news/what-you-need-to-know-about-health-canada-fees-in-2026/) Health Canada has updated its fees effective April 1, 2026, with changes applying across multiple regulated sectors, including medical devices, ... [Read more](https://qualitysmartsolutions.com/news/what-you-need-to-know-about-health-canada-fees-in-2026/) January 6, 2026 [![FDA OMUFA FY 2025 fee deadline for OTC manufacturers](https://qualitysmartsolutions.com/wp-content/uploads/2025/06/OTC-drug-facility-fee-300x168.jpg)](https://qualitysmartsolutions.com/blog/fy-2025-omufa-fees-due-june-2-what-you-need-to-know/) ### [FY 2025 OMUFA Fees Due June 2: What You Need to Know](https://qualitysmartsolutions.com/blog/fy-2025-omufa-fees-due-june-2-what-you-need-to-know/) The FDA has confirmed that FY 2025 OMUFA facility fees are due soon. If your business was registered as a ... [Read more](https://qualitysmartsolutions.com/blog/fy-2025-omufa-fees-due-june-2-what-you-need-to-know/) June 1, 2025 [![Health Canada drug submission pathways explained: NDS, SNDS, ANDS](https://qualitysmartsolutions.com/wp-content/uploads/2024/11/Health-Canadas-drug-300x181.jpg)](https://qualitysmartsolutions.com/blog/health-canadas-nds-snds-and-ands-pathways-which-one-is-right-for-you/) ### [Health Canada’s NDS, SNDS, and ANDS Pathways: Which One Is Right for You?](https://qualitysmartsolutions.com/blog/health-canadas-nds-snds-and-ands-pathways-which-one-is-right-for-you/) If you’re thinking about bringing a pharmaceutical product to the Canadian market, getting familiar with drug submission pathways is a ... [Read more](https://qualitysmartsolutions.com/blog/health-canadas-nds-snds-and-ands-pathways-which-one-is-right-for-you/) November 1, 2024 [![Proper Drug Submission Management](https://qualitysmartsolutions.com/wp-content/uploads/2023/05/QssCLE-Social-Media-Creatives-Additional-2023-05-16T145703.737-300x300.webp)](https://qualitysmartsolutions.com/blog/drug-submission-management-the-best-practices-for-success/) ### [Key Strategies to Improve Drug Submission Success](https://qualitysmartsolutions.com/blog/drug-submission-management-the-best-practices-for-success/) In the pharmaceutical industry, proper drug submission management is crucial to the success of any drug development process. The submission ... [Read more](https://qualitysmartsolutions.com/blog/drug-submission-management-the-best-practices-for-success/) May 16, 2023 [![Drug Identification Number DIN](https://qualitysmartsolutions.com/wp-content/uploads/2022/08/CLEQSS-Blog-Images-7-300x300.webp)](https://qualitysmartsolutions.com/blog/5-reasons-why-drug-identification-number-din-are-important/) ### [5 Key Reasons Why Drug Identification Numbers Matter](https://qualitysmartsolutions.com/blog/5-reasons-why-drug-identification-number-din-are-important/) Overview Manufacturers of prescription and non-prescription drugs are required to obtain a Drug Identification Number (DIN) before the drug product ... [Read more](https://qualitysmartsolutions.com/blog/5-reasons-why-drug-identification-number-din-are-important/) August 10, 2022 [![OTC Drugs](https://qualitysmartsolutions.com/wp-content/uploads/2022/04/otc-drugs-canada-300x193.jpg)](https://qualitysmartsolutions.com/blog/over-the-counter-otc-drugs-in-canada/) ### [Top 6 Questions to ask about OTC Drugs](https://qualitysmartsolutions.com/blog/over-the-counter-otc-drugs-in-canada/) 1\. What are over-the-counter drug products (OTC drugs)? Non-prescription drugs also called over-the-counter (OTC drugs), are health products that can ... [Read more](https://qualitysmartsolutions.com/blog/over-the-counter-otc-drugs-in-canada/) April 25, 2022 [![](https://qualitysmartsolutions.com/wp-content/uploads/2021/09/canna-300x193.webp)](https://qualitysmartsolutions.com/blog/summary-of-guidelines-for-advertising-health-products/) ### [Summary of Guidelines for Advertising Health Products](https://qualitysmartsolutions.com/blog/summary-of-guidelines-for-advertising-health-products/) Advertising is something almost all people experience and view daily. Yet, it can be challenging to navigate this space as ... [Read more](https://qualitysmartsolutions.com/blog/summary-of-guidelines-for-advertising-health-products/) September 21, 2021 [![](https://qualitysmartsolutions.com/wp-content/uploads/2021/07/disinfectants-300x193.jpg)](https://qualitysmartsolutions.com/blog/covid-19-and-hard-surface-disinfectants/) ### [COVID-19 and Hard Surface Disinfectants](https://qualitysmartsolutions.com/blog/covid-19-and-hard-surface-disinfectants/) COVID-19 and Hard Surface Disinfectants – What You Need to Know In Canada, chemical products that are used to clean, ... [Read more](https://qualitysmartsolutions.com/blog/covid-19-and-hard-surface-disinfectants/) July 6, 2021 [![](https://qualitysmartsolutions.com/wp-content/uploads/2020/02/drug-act-300x193.jpg)](https://qualitysmartsolutions.com/blog/protecting-canadians-from-unsafe-drugs-act/) ### [Protecting Canadians from Unsafe Drugs Act](https://qualitysmartsolutions.com/blog/protecting-canadians-from-unsafe-drugs-act/) The Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) introduces amendments to the Food and Drugs Act that will improve Health Canada’s ability to ... [Read more](https://qualitysmartsolutions.com/blog/protecting-canadians-from-unsafe-drugs-act/) February 3, 2020 [![Cosmetic Regulations in Canada and USA](https://qualitysmartsolutions.com/wp-content/uploads/2020/12/cosmetic_img-300x185.jpg)](https://qualitysmartsolutions.com/blog/post-drug-identification-number-din-changes/) ### [Post-Drug Identification Number (DIN) Changes](https://qualitysmartsolutions.com/blog/post-drug-identification-number-din-changes/) All drugs subject to the Food and Drug Regulations are required to gain premarket authorization prior to issuance of a ... [Read more](https://qualitysmartsolutions.com/blog/post-drug-identification-number-din-changes/) January 29, 2020 [![essential oil regulations ontario canada](https://qualitysmartsolutions.com/wp-content/uploads/2021/01/iStock-537472304-300x200.jpg)](https://qualitysmartsolutions.com/blog/regulatory-requirements-for-drug-identification-numbers-dins/) ### [Regulatory requirements for Drug Identification Numbers (DIN Number Canada)](https://qualitysmartsolutions.com/blog/regulatory-requirements-for-drug-identification-numbers-dins/) When Health Canada authorizes a drug to be marketed in Canada, a Drug Identification Number (DIN) is issued to the ... [Read more](https://qualitysmartsolutions.com/blog/regulatory-requirements-for-drug-identification-numbers-dins/) January 27, 2020 [![plain language labelling, health canada labelling guidance](https://qualitysmartsolutions.com/wp-content/uploads/2021/01/iStock-528181173-300x200.jpg)](https://qualitysmartsolutions.com/blog/plain-language-labelling-regulations/) ### [Plain Language Labelling Regulations](https://qualitysmartsolutions.com/blog/plain-language-labelling-regulations/) The label and package are the first points of interaction between a health product and a consumer. Prior to the ... [Read more](https://qualitysmartsolutions.com/blog/plain-language-labelling-regulations/) January 24, 2020 [![](https://qualitysmartsolutions.com/wp-content/uploads/2021/01/iStock-517993824-300x200.jpg)](https://qualitysmartsolutions.com/blog/pll-plain-language-labeling-what-it-means-and-how-it-affects-you/) ### [PLL – Plain Language Labeling: What it means and how it affects you](https://qualitysmartsolutions.com/blog/pll-plain-language-labeling-what-it-means-and-how-it-affects-you/) BACKGROUND Originally implemented in 1920 after the inception of the Federal department of Health in 1919, the Food and Drugs ... [Read more](https://qualitysmartsolutions.com/blog/pll-plain-language-labeling-what-it-means-and-how-it-affects-you/) August 6, 2017 We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Pediatric Health Products [Skip to content](https://qualitysmartsolutions.com/topic/pediatric-health-products#content) # Pediatric Health Products Search Search \[searchwp\_form id=1\] \[blog\_list\] [![Health Canada Prescription Drug List amendment restricting melatonin to prescription-only for pediatric use in Canada](https://qualitysmartsolutions.com/wp-content/uploads/2026/06/pediatric-melatonin-prescription-drug-Canada-300x157.jpg)](https://qualitysmartsolutions.com/news/health-canada-amends-prescription-drug-list-to-require-a-prescription-for-pediatric-melatonin-use/) ### [Health Canada Amends Prescription Drug List to Require a Prescription for Pediatric Melatonin Use](https://qualitysmartsolutions.com/news/health-canada-amends-prescription-drug-list-to-require-a-prescription-for-pediatric-melatonin-use/) Health Canada has amended the Prescription Drug List (PDL) to require a prescription for all sleep-related use of melatonin in ... [Read more](https://qualitysmartsolutions.com/news/health-canada-amends-prescription-drug-list-to-require-a-prescription-for-pediatric-melatonin-use/) June 10, 2026 We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Prescription Drug Updates [Skip to content](https://qualitysmartsolutions.com/topic/prescription-drug-list#content) # Prescription Drug List Search Search \[searchwp\_form id=1\] \[blog\_list\] [![Health Canada Prescription Drug List amendment restricting melatonin to prescription-only for pediatric use in Canada](https://qualitysmartsolutions.com/wp-content/uploads/2026/06/pediatric-melatonin-prescription-drug-Canada-300x157.jpg)](https://qualitysmartsolutions.com/news/health-canada-amends-prescription-drug-list-to-require-a-prescription-for-pediatric-melatonin-use/) ### [Health Canada Amends Prescription Drug List to Require a Prescription for Pediatric Melatonin Use](https://qualitysmartsolutions.com/news/health-canada-amends-prescription-drug-list-to-require-a-prescription-for-pediatric-melatonin-use/) Health Canada has amended the Prescription Drug List (PDL) to require a prescription for all sleep-related use of melatonin in ... [Read more](https://qualitysmartsolutions.com/news/health-canada-amends-prescription-drug-list-to-require-a-prescription-for-pediatric-melatonin-use/) June 10, 2026 We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Regulatory Fees Overview [Skip to content](https://qualitysmartsolutions.com/topic/regulatory-fees#content) # Regulatory Fees Search Search \[searchwp\_form id=1\] \[blog\_list\] [![Health Canada fees 2026 overview for medical devices drugs and cannabis](https://qualitysmartsolutions.com/wp-content/uploads/2026/01/health-canada-2026-news-300x157.jpg)](https://qualitysmartsolutions.com/news/what-you-need-to-know-about-health-canada-fees-in-2026/) ### [Health Canada Fees 2026: Updates for Devices, Drugs & Cannabis](https://qualitysmartsolutions.com/news/what-you-need-to-know-about-health-canada-fees-in-2026/) Health Canada has updated its fees effective April 1, 2026, with changes applying across multiple regulated sectors, including medical devices, ... [Read more](https://qualitysmartsolutions.com/news/what-you-need-to-know-about-health-canada-fees-in-2026/) January 6, 2026 We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Regulatory Update [Skip to content](https://qualitysmartsolutions.com/topic/regulatory-update#content) # Regulatory Update Search Search \[searchwp\_form id=1\] \[blog\_list\] [![Health Canada Prescription Drug List amendment restricting melatonin to prescription-only for pediatric use in Canada](https://qualitysmartsolutions.com/wp-content/uploads/2026/06/pediatric-melatonin-prescription-drug-Canada-300x157.jpg)](https://qualitysmartsolutions.com/news/health-canada-amends-prescription-drug-list-to-require-a-prescription-for-pediatric-melatonin-use/) ### [Health Canada Amends Prescription Drug List to Require a Prescription for Pediatric Melatonin Use](https://qualitysmartsolutions.com/news/health-canada-amends-prescription-drug-list-to-require-a-prescription-for-pediatric-melatonin-use/) Health Canada has amended the Prescription Drug List (PDL) to require a prescription for all sleep-related use of melatonin in ... [Read more](https://qualitysmartsolutions.com/news/health-canada-amends-prescription-drug-list-to-require-a-prescription-for-pediatric-melatonin-use/) June 10, 2026 We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## SaMD Software Overview [Skip to content](https://qualitysmartsolutions.com/topic/samd-software-as-a-medical-device#content) # SaMD Software as a Medical Device Search Search \[searchwp\_form id=1\] \[blog\_list\] [![software-as-a-medical-device-samd](https://qualitysmartsolutions.com/wp-content/uploads/2023/04/QssCLE-Social-Media-Creatives-Additional-2023-04-13T094659.053-300x300.webp)](https://qualitysmartsolutions.com/blog/software-as-medical-devices-samd-a-comprehensive-guide/) ### [Software as Medical Devices (SaMD) Registration: What You Should Know](https://qualitysmartsolutions.com/blog/software-as-medical-devices-samd-a-comprehensive-guide/) As technology continues to advance, the use of Software as Medical Devices (SaMD) is becoming more prevalent in the healthcare ... [Read more](https://qualitysmartsolutions.com/blog/software-as-medical-devices-samd-a-comprehensive-guide/) April 13, 2023 [![Health Canada Medical Devices Regulations](https://qualitysmartsolutions.com/wp-content/uploads/2023/02/QssCLE-Social-Media-Creatives-Additional-2-300x300.webp)](https://qualitysmartsolutions.com/blog/how-to-comply-with-health-canada-regulations-for-medical-devices/) ### [How to comply with Health Canada Regulations for Medical Devices?](https://qualitysmartsolutions.com/blog/how-to-comply-with-health-canada-regulations-for-medical-devices/) Introduction: Manufacturing and selling medical devices in Canada can be a complex process and requires adherence to Health Canada’s ... [Read more](https://qualitysmartsolutions.com/blog/how-to-comply-with-health-canada-regulations-for-medical-devices/) March 22, 2023 [![Medical Device License MDL MDEL SaMD](https://qualitysmartsolutions.com/wp-content/uploads/2022/11/CLE-qssBlogs-images-300x251.webp)](https://qualitysmartsolutions.com/blog/medical-device-license-mdl-mdel-samd-under-the-microscope/) ### [Medical Device License (MDL MDEL SaMD) Under the Microscope](https://qualitysmartsolutions.com/blog/medical-device-license-mdl-mdel-samd-under-the-microscope/) The Medical Device License is a legal document required to manufacture, sell, and distribute medical devices. The Medical Device Licence ... [Read more](https://qualitysmartsolutions.com/blog/medical-device-license-mdl-mdel-samd-under-the-microscope/) November 15, 2022 [![SaMD Software as a Medical Device](https://qualitysmartsolutions.com/wp-content/uploads/2022/08/iStock-1184804468-300x168.jpg)](https://qualitysmartsolutions.com/blog/how-does-the-fda-classify-software-as-a-medical-device-samd/) ### [How Does FDA Classify Software As A Medical Device (SaMD)?](https://qualitysmartsolutions.com/blog/how-does-the-fda-classify-software-as-a-medical-device-samd/) Nowadays almost all the facets of healthcare are well-equipped with the modern and latest technology tools, including software systems. ... [Read more](https://qualitysmartsolutions.com/blog/how-does-the-fda-classify-software-as-a-medical-device-samd/) September 15, 2022 We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Veterinary Health Products [Skip to content](https://qualitysmartsolutions.com/topic/veterinary-health-products-vhp#content) # Veterinary Health Products (VHP) Search Search \[searchwp\_form id=1\] \[blog\_list\] [![Pet Food Regulations](https://qualitysmartsolutions.com/wp-content/uploads/2023/08/QssCLE-Social-Media-Creatives-Additional-2023-08-24T140445.161-300x300.webp)](https://qualitysmartsolutions.com/news/aafco-new-pet-food-regulations/) ### [AAFCO Membership Approves New Pet Food Regulations for Enhanced Transparency and Consistency](https://qualitysmartsolutions.com/news/aafco-new-pet-food-regulations/) Introduction In a groundbreaking move, the Association of American Feed Control Officials (AAFCO) has given the green light to an extensive overhaul ... [Read more](https://qualitysmartsolutions.com/news/aafco-new-pet-food-regulations/) August 24, 2023 [![VHP Notification Program, VHP Notification, VHP, VHP Consulting](https://qualitysmartsolutions.com/wp-content/uploads/2022/11/iStock-1250237390-300x200.jpg)](https://qualitysmartsolutions.com/blog/vhp-consulting-5-things-about-the-vhp-notification-program/) ### [VHP Consulting 5 things about the VHP Notification Program](https://qualitysmartsolutions.com/blog/vhp-consulting-5-things-about-the-vhp-notification-program/) Introduction Health Canada oversees the importation and sale of Veterinary health products (VHPs) in Canada through the VHP Notification Program. ... [Read more](https://qualitysmartsolutions.com/blog/vhp-consulting-5-things-about-the-vhp-notification-program/) December 14, 2022 [![Veterinary Health Products in Canada](https://qualitysmartsolutions.com/wp-content/uploads/2022/05/QSS-Blog-Images-Updated-300x300.webp)](https://qualitysmartsolutions.com/blog/selling-importing-registering-your-veterinary-health-products-vhp-in-canada/) ### [Insider scoop on Selling, Importing & Registering your VHPs in Canada](https://qualitysmartsolutions.com/blog/selling-importing-registering-your-veterinary-health-products-vhp-in-canada/) Introduction: The market for animal and pet products is growing at a rapid pace. With that, there is also a ... [Read more](https://qualitysmartsolutions.com/blog/selling-importing-registering-your-veterinary-health-products-vhp-in-canada/) May 18, 2022 [![](https://qualitysmartsolutions.com/wp-content/uploads/2021/11/pet-foods-300x193.jpg)](https://qualitysmartsolutions.com/blog/how-pet-food-labels-differ-from-human-foods/) ### [How Pet Food VHP Labels Differ from Human Food Labels in 2022](https://qualitysmartsolutions.com/blog/how-pet-food-labels-differ-from-human-foods/) Pet Foods and Human Food Labels are designed to look similar yet distinct. There are some similar label requirements and ... [Read more](https://qualitysmartsolutions.com/blog/how-pet-food-labels-differ-from-human-foods/) November 8, 2021 [![](https://qualitysmartsolutions.com/wp-content/uploads/2021/03/veteranary_health_products-300x138.jpg)](https://qualitysmartsolutions.com/news/veterinary-health-products-to-be-allowed-in-livestock-feed/) ### [Veterinary Health Products to be allowed in Livestock Feed](https://qualitysmartsolutions.com/news/veterinary-health-products-to-be-allowed-in-livestock-feed/) Health Canada and the Canadian Food Inspection Agency have joined forces to evaluate the incorporation of Veterinary Health Products (VHPs) ... [Read more](https://qualitysmartsolutions.com/news/veterinary-health-products-to-be-allowed-in-livestock-feed/) March 15, 2021 We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Industry Solutions [Skip to content](https://qualitysmartsolutions.com/industries-solutions#content) # Industries Solutions 0/5 (0 Reviews) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## News and Updates [Skip to content](https://qualitysmartsolutions.com/news-updates#content) # News & Updates 0/5 (0 Reviews) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Consultation Confirmation [Skip to content](https://qualitysmartsolutions.com/free-consultation-success#content) ## Thank You Your submission is received and a Quality Smart Team member will be in touch with you shortly. While you wait, find latest news and updates for Health Canada and FDA regulations. Follow us on social media to get regular updates. [Find Latest News & Updates](https://qualitysmartsolutions.com/news/) ![check (1)](https://qualitysmartsolutions.com/wp-content/uploads/elementor/thumbs/check-1-rnvifoangbzml60os73ugmedy6nsy3y4nvp3xbvb9s.webp) 0/5 (0 Reviews) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Feed Solutions Overview [Skip to content](https://qualitysmartsolutions.com/feeds#content) \[wp-rss-aggregator\] 0/5 (0 Reviews) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Regulatory Updates Overview [Skip to content](https://qualitysmartsolutions.com/latest-updates#content) ## Latest Updates [![FDA proposed rule addressing foreign drug manufacturer and distributed manufacturing registration](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/FDA-Drug-Manufacturing-Registration-300x157.jpg)](https://qualitysmartsolutions.com/news/fda-proposes-rule-to-close-registration-gap-for-foreign-drug-manufacturers/) FDA ### [FDA Proposes Rule to Close Registration Gap for Foreign Drug Manufacturers](https://qualitysmartsolutions.com/news/fda-proposes-rule-to-close-registration-gap-for-foreign-drug-manufacturers/) The U.S. Food and Drug Administration (FDA) has proposed a rule that would close a long-standing registration gap for foreign drug manufacturers, while also simplifying how distributed manufacturing ... [Read more](https://qualitysmartsolutions.com/news/fda-proposes-rule-to-close-registration-gap-for-foreign-drug-manufacturers/) Andrew Parshad July 15, 2026 [![TikTok Shop dietary supplement compliance requirements displayed on a mobile phone screen](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/TikTok-Shop-dietary-supplement-rules-300x157.jpg)](https://qualitysmartsolutions.com/blog/selling-dietary-supplements-on-tiktok-shop-a-compliance-requirements-guide/) Blog ### [Selling Dietary Supplements on TikTok Shop: A Compliance Requirements Guide](https://qualitysmartsolutions.com/blog/selling-dietary-supplements-on-tiktok-shop-a-compliance-requirements-guide/) Selling a dietary supplement on TikTok Shop sounds like a straightforward channel expansion, until your product listing gets rejected without a clear explanation. The platform ... [Read more](https://qualitysmartsolutions.com/blog/selling-dietary-supplements-on-tiktok-shop-a-compliance-requirements-guide/) Quality Smart Solutions July 13, 2026 [![Veterinary health product registration in Canada for pet health companies](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/VHP-registration-in-Canada-300x157.jpg)](https://qualitysmartsolutions.com/blog/vhp-registration-in-canada-what-pet-health-companies-need-to-know/) Blog ### [VHP Registration in Canada: What Pet Health Companies Need to Know](https://qualitysmartsolutions.com/blog/vhp-registration-in-canada-what-pet-health-companies-need-to-know/) For pet health companies planning to sell vitamins, minerals, botanicals, or other supplement-style products for companion animals in Canada, VHP registration is one of the ... [Read more](https://qualitysmartsolutions.com/blog/vhp-registration-in-canada-what-pet-health-companies-need-to-know/) Andrew Parshad July 11, 2026 [![FDA mandatory GRAS notification rule document review for food ingredient compliance](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/FDA-GRAS-Notification-300x157.jpg)](https://qualitysmartsolutions.com/news/fda-mandatory-gras-notification-rule-could-reshape-food-ingredient-compliance-by-year-end/) FDA ### [FDA Mandatory GRAS Notification Rule Could Reshape Food Ingredient Compliance by Year End](https://qualitysmartsolutions.com/news/fda-mandatory-gras-notification-rule-could-reshape-food-ingredient-compliance-by-year-end/) For nearly three decades, companies introducing a new food or ingredient use into the U.S. market have had a choice: notify the FDA that they’ve ... [Read more](https://qualitysmartsolutions.com/news/fda-mandatory-gras-notification-rule-could-reshape-food-ingredient-compliance-by-year-end/) rkumar@qualitysmartsolutions.com July 10, 2026 [![Regulatory professional reviewing FSVP compliance documents for selling food products on Amazon USA](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/FSVP-compliance-Amazon-300x157.jpg)](https://qualitysmartsolutions.com/blog/what-amazon-usa-sellers-need-to-know-about-fsvp-compliance/) Blog ### [What Amazon USA Sellers Need to Know About FSVP Compliance](https://qualitysmartsolutions.com/blog/what-amazon-usa-sellers-need-to-know-about-fsvp-compliance/) FSVP compliance is one of the most overlooked requirements for companies exporting food, dietary supplements, and ingredient products into the United States, particularly for those selling ... [Read more](https://qualitysmartsolutions.com/blog/what-amazon-usa-sellers-need-to-know-about-fsvp-compliance/) Andrew Parshad July 9, 2026 [![Health Canada cost-benefit analysis survey on natural health product red tape reduction](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/NHP-red-tape-reduction-survey-300x157.jpg)](https://qualitysmartsolutions.com/news/health-canada-launches-cost-benefit-analysis-survey-on-natural-health-product-red-tape-reduction/) Health Canada ### [Health Canada Launches Cost-Benefit Analysis Survey on Natural Health Product Red Tape Reduction](https://qualitysmartsolutions.com/news/health-canada-launches-cost-benefit-analysis-survey-on-natural-health-product-red-tape-reduction/) Cost-Benefit Analysis Survey for Reducing Red Tape Targets Natural Health Product Regulations Health Canada has opened a cost-benefit analysis survey inviting natural health product companies ... [Read more](https://qualitysmartsolutions.com/news/health-canada-launches-cost-benefit-analysis-survey-on-natural-health-product-red-tape-reduction/) Andrew Parshad July 8, 2026 [![Laser hair removal device undergoing Health Canada compliance review on a clinical table](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/laser-hair-removal-device-300x157.jpg)](https://qualitysmartsolutions.com/blog/laser-hair-removal-device-a-guide-to-health-canada-compliance-requirements/) Blog ### [Laser Hair Removal Device: A Guide to Health Canada Compliance Requirements](https://qualitysmartsolutions.com/blog/laser-hair-removal-device-a-guide-to-health-canada-compliance-requirements/) Confirming that your laser hair removal device is Health Canada compliant is an essential step before entering the Canadian market. If you are preparing to ... [Read more](https://qualitysmartsolutions.com/blog/laser-hair-removal-device-a-guide-to-health-canada-compliance-requirements/) Gautamee Choudry Thyagraj July 8, 2026 [![Regulatory team preparing for 2026 FDA food facility registration renewal deadline](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/FDA-food-facility-registration-renewal-2026-300x157.jpg)](https://qualitysmartsolutions.com/blog/getting-ready-for-fdas-2026-food-facility-registration-renewal/) Blog ### [Getting Ready for FDA’s 2026 Food Facility Registration Renewal](https://qualitysmartsolutions.com/blog/getting-ready-for-fdas-2026-food-facility-registration-renewal/) The U.S. Food and Drug Administration (FDA) requires most registered food facilities to renew their registration every two years, and the next window opens October ... [Read more](https://qualitysmartsolutions.com/blog/getting-ready-for-fdas-2026-food-facility-registration-renewal/) Andrew Parshad July 7, 2026 [![FDA approves new sunscreen ingredient bemotrizinol](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/FDA-new-sunscreen-ingredient-300x157.jpg)](https://qualitysmartsolutions.com/news/fda-approves-new-sunscreen-ingredient-expanding-consumer-options/) Cosmetics ### [FDA Approves New Sunscreen Ingredient Expanding Consumer Options](https://qualitysmartsolutions.com/news/fda-approves-new-sunscreen-ingredient-expanding-consumer-options/) The U.S. Food and Drug Administration (FDA) has approved a new sunscreen ingredient for use in over-the-counter products sold in the United States. The agency ... [Read more](https://qualitysmartsolutions.com/news/fda-approves-new-sunscreen-ingredient-expanding-consumer-options/) Quality Smart Solutions July 7, 2026 [![FDA data integrity concerns third-party medical device testing labs documentation review](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/FDA-data-integrity-concerns-medical-device-testing-labs-300x157.jpg)](https://qualitysmartsolutions.com/news/fda-flags-data-integrity-issues-at-device-testing-labs/) FDA ### [FDA Flags Data Integrity Issues at Device Testing Labs](https://qualitysmartsolutions.com/news/fda-flags-data-integrity-issues-at-device-testing-labs/) The U.S. Food and Drug Administration (FDA) has issued notifications raising FDA data integrity concerns about medical device testing labs, signaling that the agency is scrutinizing the reliability ... [Read more](https://qualitysmartsolutions.com/news/fda-flags-data-integrity-issues-at-device-testing-labs/) Gautamee Choudry Thyagraj July 6, 2026 [![FDA guidance document on unclassified medical devices exempt from 510(k) requirements](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/510k-exemption-unclassified-medical-devices-300x157.webp)](https://qualitysmartsolutions.com/news/fda-issues-guidance-exempting-certain-unclassified-medical-devices-from-510k-premarket-review/) FDA ### [FDA Issues Guidance Exempting Certain Unclassified Medical Devices from 510(k) Premarket Review](https://qualitysmartsolutions.com/news/fda-issues-guidance-exempting-certain-unclassified-medical-devices-from-510k-premarket-review/) The U.S. Food and Drug Administration has released guidance clarifying regulatory expectations for unclassified medical devices and 510(k) premarket notification requirements, formally exempting certain device types from ... [Read more](https://qualitysmartsolutions.com/news/fda-issues-guidance-exempting-certain-unclassified-medical-devices-from-510k-premarket-review/) Gautamee Choudry Thyagraj July 3, 2026 [![Health Canada FPS requirement change for NHP licences](https://qualitysmartsolutions.com/wp-content/uploads/2026/06/NHP-Product-Licence-Applications-300x157.jpg)](https://qualitysmartsolutions.com/news/health-canada-removes-fps-submission-requirement-for-nhp-product-licence-applications/) Health Canada ### [Health Canada Removes FPS Submission Requirement for NHP Product Licence Applications](https://qualitysmartsolutions.com/news/health-canada-removes-fps-submission-requirement-for-nhp-product-licence-applications/) Health Canada has officially eliminated the finished product specification (FPS) submission requirement for Class II and Class III NHP product licence applications, streamlining the documentation that companies must submit when seeking ... [Read more](https://qualitysmartsolutions.com/news/health-canada-removes-fps-submission-requirement-for-nhp-product-licence-applications/) Andrew Parshad June 23, 2026 0/5 (0 Reviews) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Global Compliance Solutions [Skip to content](https://qualitysmartsolutions.com/#content) GUIDING YOU THROUGH GLOBAL REGULATIONS # Navigate compliance with clarity and confidence. Regulatory compliance doesn’t need to slow you down. We walk you through exactly what’s needed to get approved and stay compliant in Canada, the U.S., and beyond. [Explore our services](https://qualitysmartsolutions.com/#solutions_industry) [Schedule a call](https://qualitysmartsolutions.com/#enqy_form_sub) ## Trusted by leading companies ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/plantful.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/inner-armour.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/enzymedia.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2024/04/Hydralyte.webp) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/bausch.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/hmm.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/jamieson.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/unilever.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/biosteel.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2024/04/BANG-Rainbow-Unicorn-Logo.webp) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/optimum.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/smarty-pants.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/vital-proteins.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/vitacup.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/nestle.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/neocell.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/amazing-grass.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/smarty-pants.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/vital-proteins.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/vitacup.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/nestle.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/neocell.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/amazing-grass.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/plantful.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/inner-armour.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/enzymedia.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2024/04/Hydralyte.png) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/bausch.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/hmm.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/jamieson.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/unilever.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/smarty-pants.jpg) ## Helping businesses meet global compliance, one step at a time. With thousands of submissions behind us, we know what regulators look for. We use that experience to guide you through the process with clarity and confidence. ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/customer.webp) 3,500+ Clients guided to market ![](https://qualitysmartsolutions.com/wp-content/uploads/2026/03/projects_completed.webp) 60,000+ Projects completed ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/countries.webp) 74 Global markets navigated ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/expertise.webp) 19+ Years in compliance ## Solutions for every industry We give your business the knowledge and support to choose the right path, prepare strong submissions, and meet global standards. ![](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/food-and-bevarges.jpg) Food and Beverage In Canada, we support front-of-package labelling, Nutrition Facts Table creation, French translation, supplemented and novel food submissions, and SFCR licensing. For U.S. compliance, we help with facility registration, food label reviews, and FCE registration. [Explore more](https://qualitysmartsolutions.com/services/industry-food-beverages/%20) ![](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/ingridents-qss.jpg) Ingredients We help you meet regulatory requirements for ingredients in Canada, the U.S., Europe, Australia, and other global markets. Our support includes GRAS self-affirmation, GRAS notifications, novel food applications, safety assessments, and ingredient classification. [Explore more](https://qualitysmartsolutions.com/services/industry-ingredients/%20) ![](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/cosmetics-qss.jpg) Cosmetics In Canada, we help with cosmetic notifications, label compliance, French translation, and Canadian Cosmetic Agent services. In the U.S., we support MoCRA product listing, facility registration, manufacturer inspections, and safety substantiation. [Explore more](https://qualitysmartsolutions.com/services/industry-cosmetics/%20) ![](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/otc-drugs.jpg) OTC Drugs Our team supports Canadian drug compliance through DIN registration, NDS and ANDS submissions, and DEL applications. For U.S. compliance, we help with Drug Establishment Registration and Renewal, Drug Listing (DRLS), and National Drug Code (NDC) registration. [Explore more](https://qualitysmartsolutions.com/services/industry-otc-drugs/%20) ![](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/medical-devices.jpg) Medical Devices We support Canadian requirements including MDL, MDEL, and SaMD registration. For U.S. compliance, we guide you through 510(k) submissions, facility registration, FURLS listing, IVD and SaMD registration, and PMA pathways. [Explore more](https://qualitysmartsolutions.com/services/industry-medical-devices-canada-usa/%20) ![](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/dietary-suppliments.jpg) Dietary Supplements & NHPs We help with [NHP licensing](https://qualitysmartsolutions.com/services/canada-nhp-licensing/), site licences, and homeopathic submissions in Canada, along with [dietary supplement](https://qualitysmartsolutions.com/services/usa-dietary-supplements-compliance/) compliance in the U.S., including facility registration, NDINs, label reviews, and Supplement Facts Panels. ![](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/Veterinary-Health-Products.jpg) Veterinary Health Products We help you register VHPs with Health Canada, meet label and packaging requirements in both English and French, and act as your Canadian representative for regulatory purposes. [Explore more](https://qualitysmartsolutions.com/services/industry-veterinary-health-products/%20) ![](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/other-products.jpg) Other Products We support [cannabis](https://qualitysmartsolutions.com/services/industry-cannabis/) licences, [homeopathic](https://qualitysmartsolutions.com/services/industry-homeopathic-products/) medicines, and facility audit readiness, helping you prepare the right documentation and meet evolving compliance requirements. ## Compliance across regions We help businesses navigate regulatory systems in Canada, the U.S., and other key global markets. [![](https://qualitysmartsolutions.com/wp-content/uploads/2025/08/canada-flag.webp)\\ \\ **Canada**\\ \\ Licensing and compliance for NHPs, foods, cosmetics, OTC drugs, ingredients, medical devices, and VHPs\\ \\ ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/08/wright-arrow.webp)](https://qualitysmartsolutions.com/services/health-canada-compliance/) [![](https://qualitysmartsolutions.com/wp-content/uploads/2025/07/united-states.webp)\\ \\ **United States**\\ \\ Support for dietary supplements, food, cosmetics, OTC drugs, ingredients, and medical device registration\\ \\ ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/08/wright-arrow.webp)](https://qualitysmartsolutions.com/usa-compliance/) [![](https://qualitysmartsolutions.com/wp-content/uploads/2025/07/european-union.webp)\\ \\ **European Union (EFSA)**\\ \\ Novel food, food additive, and traditional food applications for EU market entry\\ \\ ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/08/wright-arrow.webp)](https://qualitysmartsolutions.com/european-union-compliance/) [![](https://qualitysmartsolutions.com/wp-content/uploads/2025/07/australia.webp)\\ \\ **Australia (TGA & FSANZ)**\\ \\ Regulatory support for new substances and product submissions\\ \\ ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/08/wright-arrow.webp)](https://qualitysmartsolutions.com/australia-compliance/) [![](https://qualitysmartsolutions.com/wp-content/uploads/2025/08/united-kingdom-1.webp)\\ \\ **United Kingdom (MHRA & FSA)**\\ \\ Novel food submissions and product compliance for the UK\\ \\ ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/08/wright-arrow.webp)](https://qualitysmartsolutions.com/uk-compliance/) [![](https://qualitysmartsolutions.com/wp-content/uploads/2025/07/new-zealand.webp)\\ \\ **New Zealand (FSANZ)**\\ \\ Guidance for FSANZ novel food applications and compliance requirements\\ \\ ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/08/wright-arrow.webp)](https://qualitysmartsolutions.com/australia-compliance/) [![](https://qualitysmartsolutions.com/wp-content/uploads/2025/07/china.webp)\\ \\ **China (CFDA)**\\ \\ Entry support and regulatory guidance for CFDA-compliant products\\ \\ ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/08/wright-arrow.webp)](https://qualitysmartsolutions.com/china-compliance/) [![](https://qualitysmartsolutions.com/wp-content/uploads/2025/07/flag.webp)\\ \\ **Mexico**\\ \\ Support for labelling and regulatory pathways for products sold in Mexico\\ \\ ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/08/wright-arrow.webp)](https://qualitysmartsolutions.com/mexico-compliance/) ## What our clients say We work closely with businesses of all sizes to guide them through complex regulatory processes. Here’s what some of them have shared. “I have been working with Quality Smart Solutions since starting my brand and I am extremely impressed with their attention to detail, knowledge, and fast turnaround time. I look forward to working with them for many years to come.” Aeryon Wellness “Their team was professional, knowledgeable, and efficient, making the process smooth and stress-free. Highly recommend their services!” Real House Team “If you need an amazing, reliable agency, you need to deal with them. Great consultants and amazing customer service.” Michael Zakini [Read more reviews](https://search.google.com/local/writereview?placeid=ChIJ01GKsQhhK4gRgvKaYS7GY0Q) ## How we help you succeed Proven expertise Our team includes toxicologists, scientists, and former regulatory agency experts who understand the process inside and out. Guidance from start to finish We help you make informed decisions at every stage, from assessment to submission. Efficient, reliable support We take a practical, hands-on approach to help you stay organized, avoid delays, and meet your deadlines with confidence. ## Latest news and updates Explore regulatory updates, expert articles, and events we’re attending, all in one place. [![FDA proposed rule addressing foreign drug manufacturer and distributed manufacturing registration](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/FDA-Drug-Manufacturing-Registration.jpg)\\ \\ - July 15, 2026\\ \\ **FDA Proposes Rule to Close Registration Gap for Foreign Drug Manufacturers**](https://qualitysmartsolutions.com/news/fda-proposes-rule-to-close-registration-gap-for-foreign-drug-manufacturers/) [![TikTok Shop dietary supplement compliance requirements displayed on a mobile phone screen](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/TikTok-Shop-dietary-supplement-rules.jpg)\\ \\ - July 13, 2026\\ \\ **Selling Dietary Supplements on TikTok Shop: A Compliance Requirements Guide**](https://qualitysmartsolutions.com/blog/selling-dietary-supplements-on-tiktok-shop-a-compliance-requirements-guide/) [![Veterinary health product registration in Canada for pet health companies](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/VHP-registration-in-Canada.jpg)\\ \\ - July 11, 2026\\ \\ **VHP Registration in Canada: What Pet Health Companies Need to Know**](https://qualitysmartsolutions.com/blog/vhp-registration-in-canada-what-pet-health-companies-need-to-know/) [View more resources](https://qualitysmartsolutions.com/resources/) 0/5 (0 Reviews) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Global Compliance Solutions [Skip to content](https://qualitysmartsolutions.com/#content) GUIDING YOU THROUGH GLOBAL REGULATIONS # Navigate compliance with clarity and confidence. Regulatory compliance doesn’t need to slow you down. We walk you through exactly what’s needed to get approved and stay compliant in Canada, the U.S., and beyond. [Explore our services](https://qualitysmartsolutions.com/#solutions_industry) [Schedule a call](https://qualitysmartsolutions.com/#enqy_form_sub) ## Trusted by leading companies ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/plantful.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/inner-armour.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/enzymedia.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2024/04/Hydralyte.webp) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/bausch.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/hmm.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/jamieson.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/unilever.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/biosteel.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2024/04/BANG-Rainbow-Unicorn-Logo.webp) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/optimum.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/smarty-pants.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/vital-proteins.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/vitacup.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/nestle.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/neocell.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/amazing-grass.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/smarty-pants.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/vital-proteins.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/vitacup.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/nestle.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/neocell.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/amazing-grass.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/plantful.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/inner-armour.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/enzymedia.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2024/04/Hydralyte.png) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/bausch.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/hmm.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/jamieson.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/unilever.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/smarty-pants.jpg) ## Helping businesses meet global compliance, one step at a time. With thousands of submissions behind us, we know what regulators look for. We use that experience to guide you through the process with clarity and confidence. ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/customer.webp) 3,500+ Clients guided to market ![](https://qualitysmartsolutions.com/wp-content/uploads/2026/03/projects_completed.webp) 60,000+ Projects completed ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/countries.webp) 74 Global markets navigated ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/05/expertise.webp) 19+ Years in compliance ## Solutions for every industry We give your business the knowledge and support to choose the right path, prepare strong submissions, and meet global standards. ![](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/food-and-bevarges.jpg) Food and Beverage In Canada, we support front-of-package labelling, Nutrition Facts Table creation, French translation, supplemented and novel food submissions, and SFCR licensing. For U.S. compliance, we help with facility registration, food label reviews, and FCE registration. [Explore more](https://qualitysmartsolutions.com/services/industry-food-beverages/%20) ![](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/ingridents-qss.jpg) Ingredients We help you meet regulatory requirements for ingredients in Canada, the U.S., Europe, Australia, and other global markets. Our support includes GRAS self-affirmation, GRAS notifications, novel food applications, safety assessments, and ingredient classification. [Explore more](https://qualitysmartsolutions.com/services/industry-ingredients/%20) ![](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/cosmetics-qss.jpg) Cosmetics In Canada, we help with cosmetic notifications, label compliance, French translation, and Canadian Cosmetic Agent services. In the U.S., we support MoCRA product listing, facility registration, manufacturer inspections, and safety substantiation. [Explore more](https://qualitysmartsolutions.com/services/industry-cosmetics/%20) ![](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/otc-drugs.jpg) OTC Drugs Our team supports Canadian drug compliance through DIN registration, NDS and ANDS submissions, and DEL applications. For U.S. compliance, we help with Drug Establishment Registration and Renewal, Drug Listing (DRLS), and National Drug Code (NDC) registration. [Explore more](https://qualitysmartsolutions.com/services/industry-otc-drugs/%20) ![](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/medical-devices.jpg) Medical Devices We support Canadian requirements including MDL, MDEL, and SaMD registration. For U.S. compliance, we guide you through 510(k) submissions, facility registration, FURLS listing, IVD and SaMD registration, and PMA pathways. [Explore more](https://qualitysmartsolutions.com/services/industry-medical-devices-canada-usa/%20) ![](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/dietary-suppliments.jpg) Dietary Supplements & NHPs We help with [NHP licensing](https://qualitysmartsolutions.com/services/canada-nhp-licensing/), site licences, and homeopathic submissions in Canada, along with [dietary supplement](https://qualitysmartsolutions.com/services/usa-dietary-supplements-compliance/) compliance in the U.S., including facility registration, NDINs, label reviews, and Supplement Facts Panels. ![](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/Veterinary-Health-Products.jpg) Veterinary Health Products We help you register VHPs with Health Canada, meet label and packaging requirements in both English and French, and act as your Canadian representative for regulatory purposes. [Explore more](https://qualitysmartsolutions.com/services/industry-veterinary-health-products/%20) ![](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/other-products.jpg) Other Products We support [cannabis](https://qualitysmartsolutions.com/services/industry-cannabis/) licences, [homeopathic](https://qualitysmartsolutions.com/services/industry-homeopathic-products/) medicines, and facility audit readiness, helping you prepare the right documentation and meet evolving compliance requirements. ## Compliance across regions We help businesses navigate regulatory systems in Canada, the U.S., and other key global markets. [![](https://qualitysmartsolutions.com/wp-content/uploads/2025/08/canada-flag.webp)\\ \\ **Canada**\\ \\ Licensing and compliance for NHPs, foods, cosmetics, OTC drugs, ingredients, medical devices, and VHPs\\ \\ ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/08/wright-arrow.webp)](https://qualitysmartsolutions.com/services/health-canada-compliance/) [![](https://qualitysmartsolutions.com/wp-content/uploads/2025/07/united-states.webp)\\ \\ **United States**\\ \\ Support for dietary supplements, food, cosmetics, OTC drugs, ingredients, and medical device registration\\ \\ ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/08/wright-arrow.webp)](https://qualitysmartsolutions.com/usa-compliance/) [![](https://qualitysmartsolutions.com/wp-content/uploads/2025/07/european-union.webp)\\ \\ **European Union (EFSA)**\\ \\ Novel food, food additive, and traditional food applications for EU market entry\\ \\ ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/08/wright-arrow.webp)](https://qualitysmartsolutions.com/european-union-compliance/) [![](https://qualitysmartsolutions.com/wp-content/uploads/2025/07/australia.webp)\\ \\ **Australia (TGA & FSANZ)**\\ \\ Regulatory support for new substances and product submissions\\ \\ ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/08/wright-arrow.webp)](https://qualitysmartsolutions.com/australia-compliance/) [![](https://qualitysmartsolutions.com/wp-content/uploads/2025/08/united-kingdom-1.webp)\\ \\ **United Kingdom (MHRA & FSA)**\\ \\ Novel food submissions and product compliance for the UK\\ \\ ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/08/wright-arrow.webp)](https://qualitysmartsolutions.com/uk-compliance/) [![](https://qualitysmartsolutions.com/wp-content/uploads/2025/07/new-zealand.webp)\\ \\ **New Zealand (FSANZ)**\\ \\ Guidance for FSANZ novel food applications and compliance requirements\\ \\ ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/08/wright-arrow.webp)](https://qualitysmartsolutions.com/australia-compliance/) [![](https://qualitysmartsolutions.com/wp-content/uploads/2025/07/china.webp)\\ \\ **China (CFDA)**\\ \\ Entry support and regulatory guidance for CFDA-compliant products\\ \\ ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/08/wright-arrow.webp)](https://qualitysmartsolutions.com/china-compliance/) [![](https://qualitysmartsolutions.com/wp-content/uploads/2025/07/flag.webp)\\ \\ **Mexico**\\ \\ Support for labelling and regulatory pathways for products sold in Mexico\\ \\ ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/08/wright-arrow.webp)](https://qualitysmartsolutions.com/mexico-compliance/) ## What our clients say We work closely with businesses of all sizes to guide them through complex regulatory processes. Here’s what some of them have shared. “I have been working with Quality Smart Solutions since starting my brand and I am extremely impressed with their attention to detail, knowledge, and fast turnaround time. I look forward to working with them for many years to come.” Aeryon Wellness “Their team was professional, knowledgeable, and efficient, making the process smooth and stress-free. Highly recommend their services!” Real House Team “If you need an amazing, reliable agency, you need to deal with them. Great consultants and amazing customer service.” Michael Zakini [Read more reviews](https://search.google.com/local/writereview?placeid=ChIJ01GKsQhhK4gRgvKaYS7GY0Q) ## How we help you succeed Proven expertise Our team includes toxicologists, scientists, and former regulatory agency experts who understand the process inside and out. Guidance from start to finish We help you make informed decisions at every stage, from assessment to submission. Efficient, reliable support We take a practical, hands-on approach to help you stay organized, avoid delays, and meet your deadlines with confidence. ## Latest news and updates Explore regulatory updates, expert articles, and events we’re attending, all in one place. [![FDA proposed rule addressing foreign drug manufacturer and distributed manufacturing registration](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/FDA-Drug-Manufacturing-Registration.jpg)\\ \\ - July 15, 2026\\ \\ **FDA Proposes Rule to Close Registration Gap for Foreign Drug Manufacturers**](https://qualitysmartsolutions.com/news/fda-proposes-rule-to-close-registration-gap-for-foreign-drug-manufacturers/) [![TikTok Shop dietary supplement compliance requirements displayed on a mobile phone screen](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/TikTok-Shop-dietary-supplement-rules.jpg)\\ \\ - July 13, 2026\\ \\ **Selling Dietary Supplements on TikTok Shop: A Compliance Requirements Guide**](https://qualitysmartsolutions.com/blog/selling-dietary-supplements-on-tiktok-shop-a-compliance-requirements-guide/) [![Veterinary health product registration in Canada for pet health companies](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/VHP-registration-in-Canada.jpg)\\ \\ - July 11, 2026\\ \\ **VHP Registration in Canada: What Pet Health Companies Need to Know**](https://qualitysmartsolutions.com/blog/vhp-registration-in-canada-what-pet-health-companies-need-to-know/) [View more resources](https://qualitysmartsolutions.com/resources/) 0/5 (0 Reviews) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Privacy Policy Overview [Skip to content](https://qualitysmartsolutions.com/privacy-policy#content) # Privacy Policy Your privacy is very important to us. Accordingly, we have developed this Policy in order for you to understand how we collect, use, communicate and disclose and make use of personal information. The following outlines our privacy policy. Before or at the time of collecting personal information, we will identify the purposes for which information is being collected. We will collect and use of personal information solely with the objective of fulfilling those purposes specified by us and for other compatible purposes, unless we obtain the consent of the individual concerned or as required by law. We will only retain personal information as long as necessary for the fulfillment of those purposes. We will collect personal information by lawful and fair means and, where appropriate, with the knowledge or consent of the individual concerned. Personal data should be relevant to the purposes for which it is to be used, and, to the extent necessary for those purposes, should be accurate, complete, and up-to-date. We will protect personal information by reasonable security safeguards against loss or theft, as well as unauthorized access, disclosure, copying, use or modification. We will make readily available to customers information about our policies and practices relating to the management of personal information. We are committed to conducting our business in accordance with these principles in order to ensure that the confidentiality of personal information is protected and maintained. 0/5 (0 Reviews) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Thank You Message [Skip to content](https://qualitysmartsolutions.com/medical-compliance-thank-you-canada#content) ## Thank You Your submission is received and a Quality Smart Team member will be in touch with you shortly. While you wait, find latest news and updates for Health Canada and FDA regulations. Follow us on social media to get regular updates. [Find Latest News & Updates](https://qualitysmartsolutions.com/news/) ![check (1)](https://qualitysmartsolutions.com/wp-content/uploads/elementor/thumbs/check-1-rnvifoangbzml60os73ugmedy6nsy3y4nvp3xbvb9s.webp) 0/5 (0 Reviews) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## NHP Licensing Thank You [Skip to content](https://qualitysmartsolutions.com/nhp-licensing-thank-you-canada#content) ## Thank You Your submission is received and a Quality Smart Team member will be in touch with you shortly. While you wait, find latest news and updates for Health Canada and FDA regulations. Follow us on social media to get regular updates. [Find Latest News & Updates](https://qualitysmartsolutions.com/news/) ![check (1)](https://qualitysmartsolutions.com/wp-content/uploads/elementor/thumbs/check-1-rnvifoangbzml60os73ugmedy6nsy3y4nvp3xbvb9s.webp) 0/5 (0 Reviews) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. 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[Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Thank You [Skip to content](https://qualitysmartsolutions.com/cosmetics-compliance-thank-you-canada#content) ## Thank You Your submission is received and a Quality Smart Team member will be in touch with you shortly. While you wait, find latest news and updates for Health Canada and FDA regulations. Follow us on social media to get regular updates. [Find Latest News & Updates](https://qualitysmartsolutions.com/news/) ![check (1)](https://qualitysmartsolutions.com/wp-content/uploads/elementor/thumbs/check-1-rnvifoangbzml60os73ugmedy6nsy3y4nvp3xbvb9s.webp) 0/5 (0 Reviews) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Thank You Page [Skip to content](https://qualitysmartsolutions.com/homeopathic-compliance-thank-you-canada#content) ## Thank You Your submission is received and a Quality Smart Team member will be in touch with you shortly. While you wait, find latest news and updates for Health Canada and FDA regulations. Follow us on social media to get regular updates. [Find Latest News & Updates](https://qualitysmartsolutions.com/news/) ![check (1)](https://qualitysmartsolutions.com/wp-content/uploads/elementor/thumbs/check-1-rnvifoangbzml60os73ugmedy6nsy3y4nvp3xbvb9s.webp) 0/5 (0 Reviews) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. 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[Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Submission Confirmation [Skip to content](https://qualitysmartsolutions.com/homeopathic-compliance-thank-you-usa#content) ## Thank You Your submission is received and a Quality Smart Team member will be in touch with you shortly. While you wait, find latest news and updates for Health Canada and FDA regulations. Follow us on social media to get regular updates. [Find Latest News & Updates](https://qualitysmartsolutions.com/news/) ![check (1)](https://qualitysmartsolutions.com/wp-content/uploads/elementor/thumbs/check-1-rnvifoangbzml60os73ugmedy6nsy3y4nvp3xbvb9s.webp) 0/5 (0 Reviews) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. 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[Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Thank You Confirmation [Skip to content](https://qualitysmartsolutions.com/food-beverage-compliance-thank-you-canada#content) # Thank You Your submission is received and a Quality Smart Team member will be in touch with you shortly. While you wait, find latest news and updates for Health Canada and FDA regulations. Follow us on social media to get regular updates. [Find Latest News & Updates](https://qualitysmartsolutions.com/news/) ![check (1)](https://qualitysmartsolutions.com/wp-content/uploads/elementor/thumbs/check-1-rnvifoangbzml60os73ugmedy6nsy3y4nvp3xbvb9s.webp) 0/5 (0 Reviews) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Meat or Seafood Permit [Skip to content](https://qualitysmartsolutions.com/meat-or-seafood-permit#content) # Meat or Seafood Permit Importing meat or seafood in Canada requires proper planning and licenses. Importers must furnish all the criteria outlined by CFIA prior to importation. At QSS, we help you obtain a License under the new Safe Food for Canadians Regulations to import meat, fish or seafood into Canada. [Talk To Expert](https://qualitysmartsolutions.com/meat-or-seafood-permit#meat_seafood) Importing Fish and Seafood into Canada Meat or seafood products imported into Canada are inspected by **[CFIA](https://qualitysmartsolutions.com/news/cfia-and-health-canada-joint-policy-statement-on-food-labelling-coordination/)** to prevent the trading of unsafe and mislabeled products. Thats’ why registration and license are required for all types of food, such as fish, dairy, meat, seafood and others. Get a License under the new **[SFCR](https://qualitysmartsolutions.com/blog/sfcr-what-to-expect-when-youre-inspected/)** with our help and grow your business of manufacturing, preserving, processing, packaging, labelling, **[importing](https://qualitysmartsolutions.com/news/validation-of-the-safe-food-for-canadians-licence-to-import/)** or exporting foods. ## Registration of Food Commodity The process for obtaining a License under the new **[SFCR](https://qualitysmartsolutions.com/blog/safe-food-for-canadians-regulations-how-does-it-affect-you/)** is applicable to anyone who is conducting any activities, including manufacturing, processing, treating, preserving, grading, packaging, or labelling. The process to obtain a license is governed and issued by the CFIA. However, once you get the license, you must have effective preventative controls in place. License is required for: - Importing a food - Exporting food that needs an export certificate - Slaughtering a food animal from which meat products are derived for export - Storing and handling a meat product in its imported condition for inspection by the CFI ![](https://qualitysmartsolutions.com/wp-content/uploads/2021/03/meat_seafood_img.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2021/03/seafood_image.jpg) ## Do You Need Single or Multiple Food Licenses? If you are associated with any of the above activities, you can apply for one license that covers all your establishments, activities and types of food, or you can apply multiple licenses that cover combinations of activities, establishments and types of food. To apply for a licence, submission of an application to CFIA is required that provides: - Activities for which a licence is being applied for - Location of the establishment where the activities will be conducted - Types of foods for which a licence is required - Confirmation that they have preventive controls in place Keep in mind that if you have a license or registration under the Canada Agricultural Products Act, the Meat Inspection Act or the Fish Inspection Act, it will be valid until it expires. ## Frequently Asked Questions What is the CFIA process for importing fish & seafood into Canada? Meat or seafood products imported into Canada are inspected by [**CFIA**](https://qualitysmartsolutions.com/news/cfia-and-health-canada-joint-policy-statement-on-food-labelling-coordination/) to prevent the trading of unsafe and mislabeled products. That’s why registration and licenses are required for all types of food, such as fish, dairy, meat, seafood, and others. Get a License under the new [**SFCR**](https://qualitysmartsolutions.com/blog/sfcr-what-to-expect-when-youre-inspected/) with our help and grow your business of manufacturing, preserving, processing, packaging, labelling, [**importing**](https://qualitysmartsolutions.com/news/validation-of-the-safe-food-for-canadians-licence-to-import/) or exporting foods. How many food licenses do I need? You can apply for one license that covers all your establishments, activities, and types of food, or you can apply for multiple licenses that cover combinations of activities, establishments, and types of food. To apply for a license, submission of an application to the CFIA is required that provides: - Activities for which a license is being applied for - Location of the establishment where the activities will be conducted - Types of foods for which a license is required - Confirmation that they have preventive controls in place Keep in mind that if you have a license or registration under the Canada Agricultural Products Act, the Meat Inspection Act, or the Fish Inspection Act, it will be valid until it expires. Who is the SFCR License applicable to? The process for obtaining a License under the new [**SFCR**](https://qualitysmartsolutions.com/blog/safe-food-for-canadians-regulations-how-does-it-affect-you/) is applicable to anyone who is conducting any activities, including manufacturing, processing, treating, preserving, grading, packaging, or labelling. The process to obtain a license is governed and issued by the CFIA. However, once you get the license, you must have effective preventative controls in place. License is required for: - Importing a food - Exporting food that needs an export certificate - Slaughtering a food animal from which meat products are derived for export - Storing and handling a meat product in its imported condition for inspection by the CFI Need Help for Meat or Seafood Permit License in Canada? Please complete the form below. We will respond to you soon. Company Name Contact Name E-MAIL Your phone Select all applicable Services Label compliance & French TranslationNFT CreationTMA License for Supplemented FoodsNovel Food NotificationSFCR LicenseHACCP and (PCP setup)Meat or Seafood PermitFood Label ComplianceNutrition Facts Panel CreationFood Facility Registration and RenewalGRAS NotificationSelf-affirmed GRAS Select countries of interest CanadaUSAMexicoInternational Details Submit 0/5 (0 Reviews) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## HM-DIN Registration Services [Skip to content](https://qualitysmartsolutions.com/hm-din-registration-canada#content) # HM-DIN Registration Consultancy All NHPs that used to have a Drug Identification Number (DIN) are now required to have either a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM). Our solution is available for Non-specific Health Claim-based HM-DINs Class 1 NHP Process and for Specific Claims Class 3 NHP Licensing processes. [Talk to Expert](https://qualitysmartsolutions.com/hm-din-registration-canada#hm_din_reg) Health Canada HM-DIN Registration In Canada, **[homeopathic medicines](https://qualitysmartsolutions.com/homeopathic-products-compliance/)** are licensed as DIN-HM. **[DIN](https://qualitysmartsolutions.com/hm-din-registration-canada/)** means Drug Identification Number. It is issued to a drug product to be sold in the country. It is located on the label of prescription drug products that are authorized for sale. No **[homeopathic products](https://qualitysmartsolutions.com/homeopathic-products-compliance/)** are allowed for sale in Canada without DIN. #### Why Homeopathic Medicines Have a DIN-HM On Their Label Under the **[NHP registration](https://qualitysmartsolutions.com/nhp-licensing-and-consulting-experts/)**, Homeopathic Medicines are treated differently because they can contain or be manufactured using substances that are not otherwise monitored under the [**Natural Health Products Regulations**](https://qualitysmartsolutions.com/nhp-licensing-and-consulting-experts/). The unique designation for homeopathic drugs allows consumers and compliance professionals to identify the product as homeopathic medicine. ![Homeopathic Medicines](https://qualitysmartsolutions.com/wp-content/uploads/2021/03/homeopathic_medicines.jpg) ![HM-DIN Registration](https://qualitysmartsolutions.com/wp-content/uploads/2021/03/hm_med.jpg) #### Time Taken in HM-DIN Registration Process Licensing for non-specific health claim-based HM-DINs takes 10 days and follows the class 1 NHP process and documentation for submission. Specific health claims follow the class 3 NHP licensing process which can take up to 210 days for licensing after the submission acknowledgement letter has been received. ## HM-DIN Registration Services Offered by QSS Our experts can help when it comes to **[DIN-HM Registration](https://qualitysmartsolutions.com/hm-din-registration-canada/).** In General, the registrations are done based on two types of health claims. 1. **Non-specific Health Claims** like “Homeopathic Medicine” or “Homeopathic Remedy” and no structure-function, therapeutic or preventive claim is made. 2. **Specific Health Claims** relieve bronchial symptoms, reduce stress and anxiety. The evidence can be from **[Homeopathic](https://qualitysmartsolutions.com/homeopathic-products-compliance/)** Pharmacopoeias or other sources such as Materia Medica. These types of **[homeopathic medicines](https://qualitysmartsolutions.com/homeopathic-products-compliance/)** follow the class 3 NHP licensing process. ![](https://qualitysmartsolutions.com/wp-content/uploads/2021/03/hm_din_registration.jpg) Need HM-DIN Registration Consulting Services? Please complete the form below. We will respond to you soon. Company Name Contact Name E-MAIL Your phone Select all applicable Services HM-DIN RegistrationHM-DIN Package Compliance and French TranslationNDC RegistrationUS Drug Listing (DRLS)US Drug Label ComplianceDrug Facility Registration and RenewalUS Agent Service Select countries of interest CanadaUSAMexicoInternational Details Submit 0/5 (0 Reviews) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## HM-DIN Compliance Services [Skip to content](https://qualitysmartsolutions.com/hm-din-package-compliance-and-french-translation#content) # HM-DIN Package Compliance and French Translation Meet HM-DIN Package Compliance and French Translation requirements. Create bilingual (English and French) Homeopathic Medicine Labels. As a leading compliance consulting firm, we help you adhere to Canadian labelling laws. [Book Free Consultation](https://qualitysmartsolutions.com/hm-din-package-compliance-and-french-translation#hm_din_transte) DIN-HM Package Compliance Drug Identification Number-Homeopathic Medicine (DIN-HM) is an eight-digit numerical code. It is assigned to each homeopathic medicine approved to be marketed in Canada under the NHPR. As per DIN-HM Package Compliance, DIN-HM must appear on the label so that compliance officers and consumers must know that the product has been reviewed and approved by Health Canada. ## Homeopathic Medicine Labelling Requirements Homeopathic medicines follow the same labelling requirements as [**Natural Health Products**](https://qualitysmartsolutions.com/nhp-licensing-and-consulting-experts/) ( **[NHP](https://qualitysmartsolutions.com/nhp-licensing-and-consulting-experts/)**) with a few exceptions: - Statement of recommendation for Use of Purpose is not permitted for Non-specific claim homeopathic. - Risk Statement to the effect of, “If symptoms continue or worsen, consult a health care practitioner.” “If you are pregnant or breastfeeding, consult a health care practitioner before using.” - As per Canadian labelling laws, homeopathic medicine labels must be bilingual (ie. both in English and in French as both languages are considered official in Canada). ![](https://qualitysmartsolutions.com/wp-content/uploads/2021/03/homeopathic_med.jpg) ![DIN-HM Package Compliance Regulations](https://qualitysmartsolutions.com/wp-content/uploads/2021/03/homeopathy_translate.jpg) ## How We Help Meet DIN-HM Package Compliance Regulations Backed by former Health Canada officials and a team of French Translators with more than 25 years of experience, we are proficient to help you meet **[DIN-HM](https://qualitysmartsolutions.com/hm-din-registration-canada/)** package compliance and French Translation requirements. Our solutions include: - Reviewing compliance to assure no change is required for label or package - Considering consumers of the environment of use of the medicines - Taking into account assessment and human factors methods - Preparing mock-ups of medicine package if required Need Help for HM-DIN Package Compliance and French Translation? Please complete the form below. We will respond to you soon. Company Name Contact Name E-MAIL Your phone Select all applicable Services HM-DIN RegistrationHM-DIN Package Compliance and French TranslationNDC RegistrationUS Drug Listing (DRLS)US Drug Label ComplianceDrug Facility Registration and RenewalUS Agent Service Select countries of interest CanadaUSAMexicoInternational Details Submit 0/5 (0 Reviews) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## COVID-19 Compliance Solutions [Skip to content](https://qualitysmartsolutions.com/covid-19-compliance-solutions#content) # Compliance and Import Solutions for COVID-19 If your company is seeking compliance and import solutions for COVID-19 related medical supplies including product registration for medical devices (eg. Gloves, masks, shields, gowns, respirators, testing kits), hand sanitizers and hard surface disinfectants, importing, manufacturing, packaging or labelling (these products with a medical device establishment licence, drug establishment licence or site licence), then initiate contact with us. Our experts have served over 500 clients worldwide and have successfully registered over 6000 products since 2007. We can support your compliance needs during and after licensing. ![covid-19_devices](https://qualitysmartsolutions.com/wp-content/uploads/elementor/thumbs/covid-19_devices-r9zxal6hfm7uzp0fowdhg3jno7ocvurfsbng9t62zw.jpg) Follow The Right Approach ![covid-19-products](https://qualitysmartsolutions.com/wp-content/uploads/elementor/thumbs/covid-19-products-r9zxak8n8rpiuat6s5l2yervjgaxfic7jm4xzrewsg.jpg) Quality Smart Solutions has been a remote-based consulting firm since its inception in 2007. Our team has worked from their home or remote location all these years having served over 600 clients, completing over 13,000 projects in that time successfully with satisfied partners. As demand for medical devices, disinfectants and hand sanitizers continues to increase to keep the public safe and secure our team continues to work tirelessly to deliver compliance and import solutions. Our experts continue to support your needs for natural health products, foods, cosmetics, OTC drugs, medical devices for North America. Organic Contact Us Form ![](https://forms.zohopublic.com/ghailmann/form/OrganicContactUsForm/formperma/yG1HunedKlovgTSVRS3LOIQenjWwSAsJjWTEg3SDRHY) ## Contact us today Name _\*_ Required First Required Last Company Name _\*_ Required Email _\*_ Required Field(s) inside the grid are incomplete or invalid. Expand the grid to review them. 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Get a pool of talented resources to market your products. Get licensed faster and without fail to avoid business delays. **Did You Know?** Revenue from retail e-commerce in the United States was estimated at roughly 768 billion U.S. dollars in 2021. The Statista Digital Market Outlook forecasts that by 2025, online shopping revenue in the U.S. will exceed 1.3 trillion dollars. We’ve worked with Andrew and the QSS team for 5 years and they’ve always been very knowledgeable and professional. They’re a tremendous partner to have when dealing with Health Canada compliance regulations and will always work with you to come up with the best solutions. Shams W.Pawel Amazing Grass Claim Your FREE FDA Compliance Consultation CA We’ve worked with Andrew and the QSS team for 5 years and they’ve always been very knowledgeable and professional. They’re a tremendous partner to have when dealing with Health Canada compliance regulations and will always work with you to come up with the best solutions. Shams W.Pawel Amazing Grass ![](https://qualitysmartsolutions.com/wp-content/uploads/2022/01/our-team.jpg) ## DIETARY SUPPLEMENT - Label Compliance - 30-Day Pre Market Notification - New Dietary Ingredient Notification Filing - Facility Registration And US Agent ## Food - Label Compliance And Nutrition Facts Panel Creation - Facility Registration And US Agent - Food Safety And FSMA - GRAS Self Affirmation Or Notice Filing ## Medical Devices - 510(K) Filing - Facility Registration And US Agent - IN-Vitro Diagnostic Test Registration - Label Review ## OTC DRUG - NDC and Drug Notification - Facility Registration And US Agent - Abbreviated New Drug Application (ANDA) - Label Compliance ## DISINFECTANT - EPA Registration - Label Review - Facility Registration - Claims Substantiation ## COSMETICS - Claims Assessment - Label Compliance ## FDA Compliance Made Easy and Faster FDA is a federal agency of the Department of Health and Human Services in the USA, which assures safety, quality, effectiveness, and security of human and veterinary drugs, vaccines and other biological products. The agency reviews, regulates products, such as pharmaceutical drugs, veterinary drugs, medical devices, food, cosmetics, biological products and more. If you are an organization looking for manufacturing, importing, distributing, labelling or selling medical products, health products or cosmetics in the US market, then you must be compliant with the FDA regulatory compliance. At Quality Smart Solutions, we help you by offering FDA expert compliance solutions in diverse areas, including Dietary Supplements, Foods Cosmetics, and OTC Drugs and Homeopathics (NDC). As one of your reliable FDA Consultants, we also assist you in handling FDA Registration Establishment, filling the FDA food facility registration form and getting FDA Approval for your medical devices. ## Industries We Serve Worldwide ![](https://qualitysmartsolutions.com/wp-content/uploads/2020/12/ds_pr.jpg) Dietary Supplements ![](https://qualitysmartsolutions.com/wp-content/uploads/2020/12/fab.jpg) Foods ![USA Cosmetic Regulations](https://qualitysmartsolutions.com/wp-content/uploads/2020/12/cosmetic.jpg) Cosmetic ![](https://qualitysmartsolutions.com/wp-content/uploads/2021/09/medical-devices.jpg) Medical Devices ![](https://qualitysmartsolutions.com/wp-content/uploads/2021/09/otc-drugs.jpg) OTC Drugs ![](https://qualitysmartsolutions.com/wp-content/uploads/2021/09/dietray-supplemnt.jpg) VHP ### Here From Our Amazing Clients Leverage Proven Expertise. Checkout the Companies who have Trusted Us to Become Regulatory Compliant with FDA. ![](https://qualitysmartsolutions.com/wp-content/uploads/2021/04/the-run-a-top.webp) ![](https://qualitysmartsolutions.com/wp-content/uploads/2021/04/ripple.webp) ![](https://qualitysmartsolutions.com/wp-content/uploads/2021/04/truwomen.webp) ![](https://qualitysmartsolutions.com/wp-content/uploads/2021/04/nutraplex.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2021/04/humm.webp) ![](https://qualitysmartsolutions.com/wp-content/uploads/2021/04/amazing_grass.webp) [5 Star Google Reviews](https://www.google.com/search?q=quality+smart+solutions&rlz=1C1GCEA_enUS907US907&oq=quality+smart+solutions&aqs=chrome..69i57j69i61l2j69i60.5928j0j7&sourceid=chrome&ie=UTF-8#lrd=0x882b6108b18a51d3:0x4463c62e619af282,1,,) Quality Smart Solutions © 2021 0/5 (0 Reviews) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## FDA Compliance Updates [Skip to content](https://qualitysmartsolutions.com/fda-compliance-thank-you-usa#content) ## Thank You Your submission is received and a Quality Smart Team member will be in touch with you shortly. While you wait, find latest news and updates for Health Canada and FDA regulations. Follow us on social media to get regular updates. [Find Latest News & Updates](https://qualitysmartsolutions.com/news/) ![check (1)](https://qualitysmartsolutions.com/wp-content/uploads/elementor/thumbs/check-1-rnvifoangbzml60os73ugmedy6nsy3y4nvp3xbvb9s.webp) 0/5 (0 Reviews) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Thank You Page [Skip to content](https://qualitysmartsolutions.com/fda-compliance-thank-you-ca#content) ## Thank You Your submission is received and a Quality Smart Team member will be in touch with you shortly. While you wait, find latest news and updates for Health Canada and FDA regulations. Follow us on social media to get regular updates. [Find Latest News & Updates](https://qualitysmartsolutions.com/news/) ![check (1)](https://qualitysmartsolutions.com/wp-content/uploads/elementor/thumbs/check-1-rnvifoangbzml60os73ugmedy6nsy3y4nvp3xbvb9s.webp) 0/5 (0 Reviews) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Health Canada Meetings [Skip to content](https://qualitysmartsolutions.com/health-canada-pre-submission-meeting#content) # Health Canada Pre-Submission Meeting Get guidance from professionals to submit a meeting request with Health Canada officials, stay prepared for discussion and identify potential problems that require discussion. Our experts will attend meetings to support you while discussing with officials. [Free Consultation](https://qualitysmartsolutions.com/health-canada-pre-submission-meeting#hcpsm_frm) ![](https://qualitysmartsolutions.com/wp-content/uploads/2021/04/health_cnada.jpg) ## Pre-Submission Meetings with Health Canada Pre-submission meetings with Health Canada are not limited to new drug submissions. They can be requested by sponsors before filing a submission/application for any product, including [Natural Health Products](https://qualitysmartsolutions.com/nhp-licensing-and-consulting-experts/), [Cosmetics](https://qualitysmartsolutions.com/cosmetics-regulations-compliance-services/), [Foods](https://qualitysmartsolutions.com/food-beverage-regulatory-compliance-canada/), and [medical devices](https://qualitysmartsolutions.com/medical-device-compliance-canada/). Meetings can be conducted face-to-face or by teleconference with the appropriate Directorate within Health Canada if they have any questions. Also, meetings are held before filing a clinical trial application, a drug submission/application, a request for a combination product classification, a priority review, or a submission for Extraordinary Use New Drugs (EUNDS). ## Why Pre-Submission Meetings May Be Required Health Canada Pre-Submission Meetings are held to provide a valuable opportunity for input, both from the client and from Health Canada. These meetings are used to address complex areas of submission or novel ingredients that cannot be dealt with effectively via email or telephone. In addition, the purpose of meetings could also be to: - Become familiar with Health Canada review staff - Discuss the data in the submission/application to facilitate its review - Detect potential problems or issues - Manage disputes early in the submission/application process - Provide an opportunity for discussing details of the submission/application - Get feedback about areas of concern based on regulatory requirements ![Pre-Submission Meeting](https://qualitysmartsolutions.com/wp-content/uploads/2021/04/why_pre_sub.jpg) How We Help With Health Canada Pre-Submission Meetings We will guide you through the entire process, such as submitting meeting requests, preparing for the discussion, attending with you to facilitate, lead, or provide support during your meeting with Health Canada officials. ## Frequently Asked Questions What are Health Canada pre-application meetings used for? Pre-Submission meetings are not limited to new drug submissions. They can be requested by sponsors before filing a submission/application for any product, including [Natural Health Products](https://qualitysmartsolutions.com/nhp-licensing-and-consulting-experts/), [Cosmetics](https://qualitysmartsolutions.com/cosmetics-regulations-compliance-services/), Foods, and Medical Devices. Meetings can be conducted face-to-face or by teleconference with the appropriate Directorate within Health Canada if they have any questions. Also, meetings are held before filing a clinical trial application, a drug submission/application, a request for a combination product classification, a priority review, or a submission for Extraordinary Use New Drugs (EUNDS). Why is a Health Canada pre-submission meeting required? Health Canada Pre-Submission Meetings are held to provide a valuable opportunity for input, both from the client and from Health Canada. These meetings are used to address complex areas of submission or novel ingredients that cannot be dealt with effectively via email or telephone. In addition, the purpose of meetings could also be to: - Become familiar with Health Canada review staff - Discuss the data in the submission/application to facilitate its review - Detect potential problems or issues - Manage disputes early in the submission/application process - Provide an opportunity for discussing details of the submission/application - Get feedback about areas of concern based on regulatory requirements Need Help for Health Canada Pre-Submission Meeting? Please complete the form below. We will respond to you soon. 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[Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Supplemented Foods Compliance [Skip to content](https://qualitysmartsolutions.com/services/canada-food-supplemented-foods-compliance/#content) # Supplemented Food Regulations & Supplemented Foods Facts Table (SFFT) Are you worried because your products are not meeting the FDR regulations? Fret not. Our regulatory affairs specialists will help you navigate the complex Supplemented Foods Regulations. Supplemented foods are prepackaged foods with added vitamins, minerals, amino acids, and/or other ingredients such as caffeine. These foods must meet certain requirements to be eligible for sale in Canada. The Supplemented foods regulations and the documents incorporated by reference into the Food and Drug Regulations outline the requirements for supplemented foods including compositional and labelling requirements. [Talk To a Expert](https://qualitysmartsolutions.com/services/canada-food-supplemented-foods-compliance/#enqy_form_sub) ![energy-drink](https://qualitysmartsolutions.com/wp-content/uploads/elementor/thumbs/energy-drink-r9zxaijvkswx9legyqho8vqz5i6ht99fovkurc956w.jpg) ## What are supplemented foods? Supplemented foods are those that have been fortified with additional vitamins and minerals, amino acids, and/or other ingredients such as caffeine. These products can be purchased in grocery stores or at pharmacies and may be identified by their marketing name or a statement on the product packaging. When it comes to supplemented foods, Health Canada has established the following: 1. [List of permitted supplemented food categories](https://www.canada.ca/en/health-canada/services/food-nutrition/supplemented-foods/technical-documents/list-permitted-food-categories.html) – which lists all the food categories that are permitted to be supplemented 2. [List of permitted supplemental ingredients](https://www.canada.ca/en/health-canada/services/food-nutrition/supplemented-foods/technical-documents/list-permitted-food-ingredients.html) – which list of all the supplemental ingredients that are permitted in supplemented foods, along with conditions of their use ## Food and Drug Regulations: Amendments Limitations Health Canada recently announced _Regulations Amending the [Food and Drug Regulations](https://qualitysmartsolutions.com/food-beverage-regulatory-compliance/) and the Cannabis Regulations (Supplemented Foods)_ published in the Canada Gazette, Part II on July 20, 2022. Before these regulations came into force, Health Canada let certain supplemented foods be sold through an interim measure known as the Temporary Marketing Authorization (TMA). Although the TMA process is no longer required, Health Canada is giving those who held a valid TMA a transition period (ending on December 31, 2025) for their supplemented foods to become compliant with the new regulations. Products eligible for the transition include supplemented foods that had a valid TMAL at the time of coming into force, as well as products that applied for a TMAL before the coming into force of the regulations and subsequently received a Health Canada notification. Any new supplemented food, other than those previously mentioned as eligible for the transition period, coming onto the market after the coming into force of the food regulations ( [conventional vs. supplemented foods](https://qualitysmartsolutions.com/blog/conventional-foods-vs-supplemented-foods/)), will be required to immediately comply with the new regulations. ![proten](https://qualitysmartsolutions.com/wp-content/uploads/elementor/thumbs/proten-r9zxaijvkswx9legyqho8vqz5i6ht99fovkurc956w.jpg) ![Supplemented Food Facts Table](https://qualitysmartsolutions.com/wp-content/uploads/elementor/thumbs/CLE-Blogs-images-6-rnvh6poqmwcwdhfwq6f7p5effofhibkkpc967xveyw.webp) ## Supplemented Food Facts Table (SFFT) Requirements The Supplemented Food Facts Table (SFFt) is similar to the Nutrition Facts Table (NFT) which is required for prepackaged food products. The SFFt requires the name and absolute amount of each supplemental ingredient under the “Supplemented with” heading. When vitamins, minerals, amino acids, or other supplemental ingredients are added to a product, they will also be included under this heading. A statement to interpret this requirement will be mandatory on supplemented foods to clarify that the amounts of supplemental ingredients declared by the SFFT include both supplemental and naturally occurring quantities. Sample SFFt formats are available on the Health Canada website. Cautionary Statements & Identifier List There are certain ingredients or levels of ingredients that may trigger a requirement for a supplemented food product to include cautionary statements on the label. Warnings must be separated from other information on the label and appear in a way that you can understand them easily. Supplemented food products must also display an “SFCI” (Supplemented Food Caution Identifier) on the principal display panel. The SFCI will show the word “Supplemented” and also have an exclamation mark to prevent any confusion. ## Supplemented Foods Regulations Transition Timeline As of July 21, 2022, all TMA approvals for existing supplemented foods on the market will expire. Health Canada will continue to process TMA license applications that have already been submitted, but existing supplemented foods on the market approved under the TMA framework will have until Jan 1, 2026, to become compliant with the new regulations ![Supplemented Foods](https://qualitysmartsolutions.com/wp-content/uploads/elementor/thumbs/Supplemented-Foods-Webpage-QSS-rnvgunfaxftagga4htcnmzbg7yzi6dq7unv6g6pcqg.webp) ![Permitted Supplemented Food Categories and Ingredients by Health Canada:](https://qualitysmartsolutions.com/wp-content/uploads/elementor/thumbs/Supplemented-Foods-rnvgus4hvm0uzorveiqpjnsryl8qsn78qa49whkbyg.webp) ## Permitted Supplemented Food Categories and Ingredients by Health Canada **List of Permitted Supplemental Ingredients:** This list will capture substances that might be added to a specific food as a supplemental ingredient grouped as; mineral nutrients, amino acids, vitamins, etc. The conditions of use for each supplemental ingredient are also very detailed. Some examples of this could include the maximum levels of use in a product and ingredients that trigger an SFCI or cautionary statement. **List of Permitted Supplemented Food Categories:** This list captures the various categories of food for which supplemental ingredients can be added. Various categories of food are exempt from the category like alcohol and fortified foods. Health Canada can update these lists, and stakeholders can request changes (including additions, removals, or modifications) through a premarket submission process. This submission must be accompanied by supporting information demonstrating that the proposed change would be safe for Canadians. ## Regulatory Experts help to prevent pitfalls/refusals 01. **Regulatory Precision**: Regulatory experts possess an in-depth understanding of the complex and ever-evolving regulations governing supplemented foods. They ensure your Supplemented Foods Facts Tables adhere to all relevant standards, avoiding costly compliance issues. 02. **Comprehensive Knowledge**: These experts stay updated on the latest regulatory changes and requirements, guaranteeing that your product labels reflect current guidelines, thereby reducing the risk of non-compliance. 03. **Risk Mitigation**: Regulatory experts are adept at identifying potential compliance pitfalls and addressing them preemptively. This proactive approach minimizes the risk of regulatory fines, product recalls, or legal actions. 04. **Consumer Trust**: Accurate and compliant Supplemented Foods Facts Tables enhance consumer trust. When customers perceive your products as transparent and trustworthy, they are more likely to make informed purchasing decisions. 05. **Competitive Advantage**: Compliance can set you apart in a crowded marketplace. Regulatory experts ensure that your products stand out for their adherence to quality and regulatory standards, giving you a competitive edge. 06. **Resource Optimization**: By outsourcing regulatory tasks to experts, you free up your internal teams to concentrate on core business activities like product development and marketing, improving overall efficiency. 07. **Time Efficiency**: Regulatory experts streamline the compliance process, expediting the time it takes to get your products to market. This can be a game-changer in the fast-paced world of supplemented foods. 08. **Global Expansion**: If you have ambitions for international markets, regulatory experts can navigate the complexities of various regulatory frameworks, enabling smooth global expansion. 09. **Cost Savings**: While it may seem like an additional expense, utilizing regulatory experts often results in cost savings. Their proficiency minimizes the risk of costly compliance errors or delays, optimizing your budget. 10. **Legal Compliance**: Non-compliance can lead to legal repercussions. Regulatory experts ensure your business operates within the bounds of the law, shielding you from legal complications. 11. **Product Integrity**: Accurate labeling reinforces the integrity of your products. Regulatory experts help maintain product consistency and quality, which is essential for long-term success. ![Regulatory Precision: Regulatory experts possess an in-depth understanding of the complex and ever-evolving regulations governing supplemented foods. They ensure your Supplemented Foods Facts Tables adhere to all relevant standards, avoiding costly compliance issues. Comprehensive Knowledge: These experts stay updated on the latest regulatory changes and requirements, guaranteeing that your product labels reflect current guidelines, thereby reducing the risk of non-compliance. Risk Mitigation: Regulatory experts are adept at identifying potential compliance pitfalls and addressing them preemptively. This proactive approach minimizes the risk of regulatory fines, product recalls, or legal actions. Consumer Trust: Accurate and compliant Supplemented Foods Facts Tables enhance consumer trust. When customers perceive your products as transparent and trustworthy, they are more likely to make informed purchasing decisions. Competitive Advantage: Compliance can set you apart in a crowded marketplace. Regulatory experts ensure that your products stand out for their adherence to quality and regulatory standards, giving you a competitive edge. Resource Optimization: By outsourcing regulatory tasks to experts, you free up your internal teams to concentrate on core business activities like product development and marketing, improving overall efficiency. Time Efficiency: Regulatory experts streamline the compliance process, expediting the time it takes to get your products to market. This can be a game-changer in the fast-paced world of supplemented foods. Global Expansion: If you have ambitions for international markets, regulatory experts can navigate the complexities of various regulatory frameworks, enabling smooth global expansion. Cost Savings: While it may seem like an additional expense, utilizing regulatory experts often results in cost savings. Their proficiency minimizes the risk of costly compliance errors or delays, optimizing your budget. Legal Compliance: Non-compliance can lead to legal repercussions. Regulatory experts ensure your business operates within the bounds of the law, shielding you from legal complications. Product Integrity: Accurate labeling reinforces the integrity of your products. Regulatory experts help maintain product consistency and quality, which is essential for long-term success.](https://qualitysmartsolutions.com/wp-content/uploads/2023/09/QssCLE-Social-Media-Creatives-Additional-2023-09-16T100410.476.webp) ## Frequently Asked Questions What criteria do I need to qualify for a TMA license? All supplemented [**foods and beverages**](https://qualitysmartsolutions.com/food-beverage-regulatory-compliance/) must meet the following general criteria to be eligible for a [**TMA**](https://qualitysmartsolutions.com/blog/summary-of-guidelines-for-advertising-health-products/) License: - The [**supplemented food**](https://qualitysmartsolutions.com/blog/conventional-foods-vs-supplemented-foods/) must be safe for use under TMA conditions - The food must be pre-packaged - They must contain a non-compliant vitamin, mineral - Must have amino acid and an unapproved novel food - They shall neither contain alcohol nor be represented as water What is a Temporary Market Authorization (TMA License)? A Temporary Market Authorization (TMA) is issued for foods that fail to meet the Canadian Food and [**Drug**](https://qualitysmartsolutions.com/otc-drug-compliance-din/) Regulations (FDR). The purpose of [**TMA**](https://qualitysmartsolutions.com/blog/summary-of-guidelines-for-advertising-health-products/) is to allow marketing of food so that specific data can be gathered and evaluated by Health Canada with the ultimate goal of finalizing an amendment to the FDR. What foods & beverages require a TMA License? Products that may require a TMA are [**foods and beverages**](https://qualitysmartsolutions.com/food-beverage-regulatory-compliance/) [**supplemented**](https://qualitysmartsolutions.com/dietary-supplement-regulation-fda/) with minerals, vitamins or other bioactive ingredients (for example, the addition of Omega-3 in orange juice). On a successful TMA submission, a Temporary Marketing Authorization License (TMAL) is issued by Health Canada, signifying official approval. Need Help for TMA License for Supplemented Foods? Please complete the form below. We will respond to you soon. Company Name Contact Name E-MAIL Your phone Select all applicable Services Label compliance & French TranslationNFT CreationTMA License for Supplemented FoodsNovel Food NotificationSFCR LicenseHACCP and (PCP setup)Meat or Seafood PermitFood Label ComplianceNutrition Facts Panel CreationFood Facility Registration and RenewalGRAS NotificationSelf-affirmed GRAS Select countries of interest CanadaUSAMexicoInternational Details Submit 0/5 (0 Reviews) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Regulatory Compliance Services [Skip to content](https://qualitysmartsolutions.com/fda-and-health-canada-compliance#content) # Your Bridge to Success Starts with Us! 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Select International Compliance Category _\*_ N/A -Select-Natural Health ProductsDietary SupplementsMedical DevicesOTC DrugsHomeopathic DrugsVeterinary Health ProductsFood & BeveragesCosmetic ProductsCanna/Psy ProductsOther - Regulatory cost budget _\*_ N/A -Select-1000 - 50005001 - 10,00010,001 - 20,000above $20,000 - When do you plan to launch? _\*_ N/A -Select-6 months or lessmore than 6 months - Please provide additional details / requirements _\*_ N/A - _NEXT_ - _Back_ _Submit_ ## Error Occurred You haven't verified your email yet, click here to receive a verification email. ![](https://forms.zohopublic.com/ghailmann/form/BookYourFreeConsultationwithOurComplianceExpertsTo/formperma/aEtSjq2Pr2eDhRfHjKhza7nVCxRYygrQT1IJqvnnois) This file format is not supported by your browser for preview. 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We make it easy for you to navigate the complexities of regulatory affairs. Our experienced team will guide you through the necessary processes from start to finish, ensuring your product has the best chance of being approved. We have solutions for every size and type of project. Our approach is simple: you provide the product, and we outline the appropriate regulatory steps to meet FDA and Health Canada regulatory requirements. We will ensure all aspects of your product are compliant and ready for the North American Market. ### Hear From Our Amazing Clients Leverage proven expertise. Checkout companies who have trusted us to become regulatory compliant with FDA. ![](https://qualitysmartsolutions.com/wp-content/uploads/2021/04/vital_protiens_logo.webp) ![](https://qualitysmartsolutions.com/wp-content/uploads/2021/04/all_one_magic.webp) ![](https://qualitysmartsolutions.com/wp-content/uploads/2021/04/ripple.webp) ![](https://qualitysmartsolutions.com/wp-content/uploads/2021/04/the-run-a-top.webp) ![](https://qualitysmartsolutions.com/wp-content/uploads/2022/09/derma-e-logo.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2021/04/upspring_logo.webp) [5 Star Google Reviews](https://www.google.com/search?q=quality+smart+solutions&rlz=1C1GCEA_enUS907US907&oq=quality+smart+solutions&aqs=chrome..69i57j69i61l2j69i60.5928j0j7&sourceid=chrome&ie=UTF-8#lrd=0x882b6108b18a51d3:0x4463c62e619af282,1,,) ## Book Your Free Consultation with Our Compliance Experts Today 0/5 (0 Reviews) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## OTC Drug Compliance [Skip to content](https://qualitysmartsolutions.com/services/canada-otc-drugs-compliance/#content) # OTC Drugs & Controlled Substances Compliance in Canada Selling OTC drugs or working with controlled substances in Canada means navigating Health Canada’s regulatory framework. The requirements are specific and the pathways are distinct. Since 2007, we have helped drug companies, research organizations, and controlled substances operators get registered, licensed, and compliant. [Start Compliance Assessment](https://qualitysmartsolutions.com/services/canada-otc-drugs-compliance/#enqy_form_sub) ![](https://qualitysmartsolutions.com/wp-content/uploads/2026/03/otc-drugs-compliance-img.jpg) ## What It Takes to Sell OTC Drugs or Work with Controlled Substances in Canada Health Canada regulates OTC drugs under the Food and Drugs Act and its associated regulations. Before a drug product can be sold in Canada, it needs a Drug Identification Number (DIN) confirming Health Canada has reviewed the formulation, labelling, and manufacturing standards. Companies distributing or importing drugs also need a Drug Establishment Licence (DEL) to authorize their facility and activities. For organizations working with scheduled substances such as psilocybin, MDMA, or pharmaceutical narcotics, the Controlled Drugs and Substances Act (CDSA) applies, and a Dealer’s Licence or Section 56 exemption from Health Canada is required before any activities can begin. The regulatory pathway varies depending on whether your product is an OTC drug following a monograph, a new drug requiring a full submission, or a controlled substance requiring CDSA authorization. Getting the right licence or registration in place before you begin, and maintaining it as your operations evolve, is what keeps your products on the shelf and your programs running without disruption. Operating without the right approvals in place, whether a DIN, a DEL, or a CDSA licence, exposes your organization to product seizure, import refusal, programme shutdown, or enforcement action from Health Canada. Beyond the regulatory risk, there is the commercial cost: delays set back launches and research timelines by months. We help you avoid both. ## What You Need to Operate in Canada's Drug and Controlled Substances Space A Drug Identification Number (DIN) Every drug sold in Canada must have a DIN issued by Health Canada. The DIN confirms that the product’s ingredients, strength, dosage form, and labelling have been reviewed and accepted. A Drug Establishment Licence (DEL) Any company fabricating, packaging, labelling, testing, importing, distributing, or wholesaling drugs in Canada must hold a valid DEL that covers those specific activities. GMP Compliance DEL holders must meet the Good Manufacturing Practice requirements set out in Division 2 of the Food and Drug Regulations. This covers facilities, equipment, personnel, documentation, testing, and quality systems. Compliant Labelling OTC drug labels must meet Health Canada’s requirements for bilingual text, ingredient listing, directions for use, warnings, and DIN display. Labels are reviewed as part of the DIN application process. Ongoing Reporting and Licence Maintenance DEL holders must renew their licence annually by April 1st, report changes through the appropriate amendment process, and maintain records in line with Health Canada’s requirements. ## Our OTC Drug & Controlled Substances Services [![](https://qualitysmartsolutions.com/wp-content/uploads/2026/03/applications.webp)\\ \\ DIN Application \\ \\ We prepare and manage Drug Identification Number applications for OTC and prescription drug products, covering new applications, amendments, and renewals.](https://qualitysmartsolutions.com/services/canada-otc-drugs-din-application/) [![](https://qualitysmartsolutions.com/wp-content/uploads/2026/03/registration.webp)\\ \\ NDS and ANDS Registration \\ \\ For companies filing New Drug Submissions or Abbreviated New Drug Submissions with Health Canada, we support the full preparation, documentation, and submission process.](https://qualitysmartsolutions.com/services/canada-otc-drugs-nds-ands-registration/) [![](https://qualitysmartsolutions.com/wp-content/uploads/2026/03/license.webp)\\ \\ Drug Establishment Licence (DEL) \\ \\ We guide drug companies through the DEL application process, from initial GMP gap assessment through submission, inspection readiness, and annual renewal.](https://qualitysmartsolutions.com/services/canada-otc-drugs-drug-establishment-license/) [![](https://qualitysmartsolutions.com/wp-content/uploads/2026/03/compliance.webp)\\ \\ Psychedelics Compliance \\ \\ For companies pursuing Health Canada-sanctioned therapeutic or research pathways involving controlled substances, we provide regulatory guidance tailored to this specialized framework.](https://qualitysmartsolutions.com/services/canada-psychedelics/) ## Types of OTC Products We Have Helped License Our team has supported DIN applications and compliance work across a wide range of OTC drug product categories in Canada, including: ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/10/sports-nutrition.webp) Sports Nutrition Products ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/10/sunscreen.webp) Sunscreens ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/10/hand-sanitizer.webp) Hand Sanitizers ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/08/dietary-supplements.webp) Multivitamins ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/10/supplements.webp) Super Greens and Health Products ![](https://qualitysmartsolutions.com/wp-content/uploads/2026/03/energy-drink.webp) Energy Boost Products ![](https://qualitysmartsolutions.com/wp-content/uploads/2025/10/gummies.webp) Gummies ## Who We Work With Canadian Drug Manufacturers Companies fabricating OTC or prescription drug products in Canada that need DEL compliance, GMP gap assessment, and product registration support. International Companies Entering Canada Foreign manufacturers and brand owners looking to import or distribute drug products in Canada, including DEL foreign site annexation, DIN applications, and label compliance for the Canadian market. Health and Wellness Brands Expanding Into Drug Categories CPG and supplement brands whose products cross over into OTC drug territory under Health Canada’s classification framework, requiring DIN registration rather than or in addition to NPN licensing. Importers and Distributors Canadian importers and distributors who need a DEL to bring drug products into the country and require ongoing compliance support to maintain their licence in good standing. Research and Clinical Organizations Organizations working within Health Canada-sanctioned controlled substances frameworks, including psychedelic-assisted therapy research programs requiring regulatory support and licence management. ## Controlled Substances Under the CDSA Beyond OTC drugs, the OTC Drugs & Controlled Substances section also covers organizations working under Canada’s Controlled Drugs and Substances Act (CDSA). The CDSA governs the possession, production, distribution, import, and export of scheduled substances, from pharmaceutical narcotics to psilocybin and MDMA. Any organization conducting activities with these substances needs a Dealer’s Licence or Section 56 exemption from Health Canada before those activities can legally begin. For organizations working specifically in the psychedelics space, including psilocybin research programs, MDMA clinical trials, and approved therapeutic applications, we provide dedicated licensing and compliance support under the CDSA. [See Psychedelics Licensing and Compliance](https://qualitysmartsolutions.com/services/canada-psychedelics/) ![](https://qualitysmartsolutions.com/wp-content/uploads/2026/03/otc-drugs-substances.jpg) ## Why work with us? Since 2007, navigating Health Canada OTC drug requirements, across DIN applications, DEL registrations, and controlled substance frameworks. We work across both product registration and facility compliance, so you are not managing two separate consultants for the same regulatory picture. Experience with domestic manufacturers, international importers, and brands crossing over from the supplement or food space into drug territory. We flag the issues most clients do not know to ask about, before they become delays or enforcement findings. ## From Our Blog The latest on DIN applications, DEL requirements, and OTC drug compliance in Canada. [![Health Canada fees 2026 overview for medical devices drugs and cannabis](https://qualitysmartsolutions.com/wp-content/uploads/2026/01/health-canada-2026-news.jpg)\\ \\ - January 6, 2026\\ \\ **Health Canada Fees 2026: Updates for Devices, Drugs & Cannabis**](https://qualitysmartsolutions.com/news/what-you-need-to-know-about-health-canada-fees-in-2026/) [![FDA OMUFA FY 2025 fee deadline for OTC manufacturers](https://qualitysmartsolutions.com/wp-content/uploads/2025/06/OTC-drug-facility-fee.jpg)\\ \\ - June 1, 2025\\ \\ **FY 2025 OMUFA Fees Due June 2: What You Need to Know**](https://qualitysmartsolutions.com/blog/fy-2025-omufa-fees-due-june-2-what-you-need-to-know/) [![Health Canada drug submission pathways explained: NDS, SNDS, ANDS](https://qualitysmartsolutions.com/wp-content/uploads/2024/11/Health-Canadas-drug.jpg)\\ \\ - November 1, 2024\\ \\ **Health Canada’s NDS, SNDS, and ANDS Pathways: Which One Is Right for You?**](https://qualitysmartsolutions.com/blog/health-canadas-nds-snds-and-ands-pathways-which-one-is-right-for-you/) ## Frequently Asked Questions What is a DIN and does my product need one? A Drug Identification Number (DIN) is Health Canada’s product-level authorization for a drug sold in Canada. If your product is classified as a drug under the Food and Drugs Act, whether OTC or prescription, it needs a DIN before it can be sold. The key question is whether your product falls under the drug definition, which turns on its ingredients, the claims you are making, and how it is presented to consumers. Some products that are sold as supplements in the US are classified as drugs in Canada, which means they need a DIN rather than an NPN. We can help you determine which pathway applies before you invest in the wrong registration. What is the difference between a DIN and an NPN? A Drug Identification Number (DIN) applies to drugs regulated under the Food and Drug Regulations, including most OTC medications, sunscreens, hand sanitizers, and prescription drugs. A Natural Product Number (NPN) applies to natural health products regulated under the Natural Health Products Regulations, such as vitamins, minerals, and herbal remedies. The classification of your product determines which pathway applies, and in some cases the boundary is not obvious. If you are unsure which framework covers your product, this is worth sorting out early. Can I use the same product formula I sell in the US for the Canadian market? Not automatically. Canada has its own review process for each product, and Health Canada may have different monograph standards, ingredient restrictions, or acceptable concentration limits than the FDA. Your US label will also not meet Canadian requirements. We review your existing formulation and labelling against Canadian standards and identify what needs to change before you submit a DIN application. How long does a DIN application take? Timelines vary depending on the submission type. OTC products that follow a Health Canada monograph move faster than products requiring a full new drug submission. In general, plan for several months from submission to issuance, and factor in time to prepare a complete application package. Incomplete submissions or those with labelling issues can extend the timeline significantly. We prepare submissions that are complete and well-documented, which reduces back-and-forth with Health Canada reviewers. Do I need a DEL if I am just importing OTC drugs into Canada? Yes. Any company importing drugs into Canada for distribution or sale must hold a Drug Establishment Licence covering the importation activity. Your licence must also list all foreign facilities involved in fabricating, packaging, or testing the products you import. This is a separate requirement from the DIN and applies to the company and its operations, not just the product. What does QSS actually do during a DIN application? We prepare the full submission package: product monograph review or new drug submission as applicable, formulation documentation, labelling review and bilingual compliance, supporting evidence, and the application filing itself. We verify the submission before it goes to Health Canada, track it through the review process, and respond to any reviewer questions or deficiency notices on your behalf. The goal is a clean, complete submission that moves through review without unnecessary delays. We sell gummies in the US as a supplement. Would they need a DIN in Canada? It depends on the ingredients and the claims. Many gummy products sold as dietary supplements in the US fall under the Natural Health Products Regulations in Canada and require an NPN, not a DIN. However, if your gummies contain drug ingredients, or if the claims you are making go beyond what is permitted under the NHP framework, a DIN may be required. Some products need both. We review the product and the intended claims and tell you exactly which pathway applies before you proceed. ## Ready to Get Started? Talk to a specialist about your OTC drug compliance situation. Whether you are working through a DIN application, setting up a DEL, or figuring out which regulatory pathway applies to your product, we can help you map out the right next steps. [Talk to a Specialist](https://qualitysmartsolutions.com/services/canada-otc-drugs-compliance/#enqy_form_sub) ## Need Help Or Have A Question? [+1 800 396 5144](tel:+1%20800%20396%205144) ### [+1 800 396 5144](tel:+1%20800%20396%205144) [Email us](mailto:info@qualitysmartsolutions.com) ### [Email us](mailto:info@qualitysmartsolutions.com) [Talk to an expert](https://qualitysmartsolutions.com/services/canada-otc-drugs-compliance/#npn_registration) ### [Talk to an expert](https://qualitysmartsolutions.com/services/canada-otc-drugs-compliance/\#npn_registration) 0/5 (0 Reviews) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## USA Cosmetics Compliance [Skip to content](https://qualitysmartsolutions.com/services/usa-cosmetics-compliance/#content) # Comply with the Updated MoCRA Cosmetic Regulations by FDA We assist manufacturers, importers, and distributors of cosmetic products with cosmetic safety assessments, regulatory support, and cosmetic label design and compliance. Our experts can review your artwork and help prepare a fully compliant, print-ready art file to enable you to bring your cosmetic products to market without compromising compliance. MoCRA is a new law that came into effect on December 29, 2023 that aims to improve the safety and transparency of cosmetic products in the United States. We can assist with the changes brought about by the act and what it means for consumers and manufacturers of cosmetic products. [Click here to **Book FREE Consultation** with FDA regulatory experts.](https://qualitysmartsolutions.com/services/usa-cosmetics-compliance/#frm_block) ![](https://qualitysmartsolutions.com/wp-content/uploads/2024/05/cosmetic-regulations.jpg) Cosmetics are products that are professionally made for cleansing and improving the complexion, skin, hair, or teeth. These products fall under US cosmetic regulations. Some common cosmetics are skincare products, fragrances, hair, and manicure products. The Cosmetic Industry is the most valuable beauty and personal care market in the world. Complying with the regulations is key, beginning with the cosmetic product development stage all the way to market execution is essential. ## What is MoCRA? MoCRA or the Modernization of Cosmetics Regulation Act of 2022, is a new law that was signed into law in December 2019. The act aims to modernize the regulation of cosmetic products in the United States by giving the FDA more authority to regulate cosmetic products and ingredients. ![mocra cosmetics Labels](https://qualitysmartsolutions.com/wp-content/uploads/2022/02/cosmo.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2024/05/cosmetic-img-1.jpg) MoCRA is important because it ensures that cosmetic products are safe, properly labeled, and manufactured according to stringent standards. The act requires cosmetic manufacturers to register their facilities with the FDA and to report any serious adverse events associated with their products. Overall, the act is designed to improve the safety and transparency of cosmetic products in the US. ## How does MoCRA Impact Cosmetic Product Manufacturers? The Modernization of Cosmetic Regulation Act significantly impacts cosmetic product manufacturers. Under the new law, manufacturers must register their facilities with the FDA and provide the agency with a list of all cosmetic products they manufacture. They must also report any serious adverse events associated with their products to the FDA within 15 days of becoming aware of the event. Plus, the FDA has the authority to order a recall of a cosmetic product if it is found to be unsafe or misbranded. Manufacturers must also comply with new labeling requirements, including listing all ingredients on the product label in order of predominance. Overall, the act places greater responsibility on cosmetic product manufacturers to ensure the safety and transparency of their products. ![FDA cosmetic regulations](https://qualitysmartsolutions.com/wp-content/uploads/2023/02/QSS-Images-2023-02-09T130115.315.webp) ## Need Help with MoCRA Compliance Solutions? We offer everything you need to meet MoCRA requirements, from listing your product and registering your facility to providing a US agent for your manufacturing site. We’ll help prove the safety of your cosmetic product and its ingredients, assist with reporting adverse reactions, and manage recalls if needed. Below are our sought-after MoCRA solutions. ### Hear from Some of Our Amazing Clients Proven Expertise. Companies that have placed their trust in us to meet the cosmeticregulations in the United States. ![](https://qualitysmartsolutions.com/wp-content/uploads/2021/04/goddess-garden.webp) ![](https://qualitysmartsolutions.com/wp-content/uploads/2021/04/all_one_magic.webp) ![](https://qualitysmartsolutions.com/wp-content/uploads/2021/04/kind-lips.webp) ![](https://qualitysmartsolutions.com/wp-content/uploads/2021/04/yes-to.webp) ![](https://qualitysmartsolutions.com/wp-content/uploads/2021/04/thayers-natural.webp) ![](https://qualitysmartsolutions.com/wp-content/uploads/2021/04/my-magic-mud.webp) [5 Star Google Reviews](https://www.google.com/search?q=quality+smart+solutions&rlz=1C1GCEA_enUS907US907&oq=quality+smart+solutions&aqs=chrome..69i57j69i61l2j69i60.5928j0j7&sourceid=chrome&ie=UTF-8#lrd=0x882b6108b18a51d3:0x4463c62e619af282,1,,) ## Frequently Asked Questions How much does it cost to get FDA approval for cosmetics? There is no fee associated with cosmetics in the USA. What are the new MOCRA Requirements for Labelling? - **A U.S.** address, - **A U.S.** phone number, or - Electronic contact information for receiving adverse event reports Cosmetic products containing fragrance allergens must update labels to list these allergens. Professional cosmetic products must prominently indicate that they are to be used solely by licensed professionals and are compliant with existing cosmetic labeling norms. If you need help with any of these steps let us know by emailing [info@qualitysmartsolutions.com](mailto:info@qualitysmartsolutions.com). What types of claims or standards can the FDA set? Cosmetic claims include texts, images or symbols that are used by brands to present the characteristics of a cosmetic product and are a real advertising tool for customers. Under the _Federal Food, Drug and Cosmetic Act_(FD&C Act) cosmetics must not be misbranded. For example, all cosmetic products must be safe for consumers by being properly labelled with the customary conditions of use. Are there any ingredients that are prohibited for use in cosmetics? The following ingredients are prohibited from being used in cosmetic products: mercury compounds, vinyl chloride, bithionol, halogenated salicylanilides, zirconium complexes in aerosol cosmetics, chloroform, methylene chloride, chlorofluorocarbon propellants and hexachlorophene. What is the Modernization of Cosmetic Regulation Act? The Modernization of Cosmetic Regulation Act is a new law that was signed into law in December 2019. The act aims to modernize the regulation of cosmetic products in the United States by giving the FDA more authority to regulate cosmetic products and ingredients. The act also requires cosmetic manufacturers to register their facilities with the FDA and to report any serious adverse events associated with their products. Overall, the act is designed to improve the safety and transparency of cosmetic products in the US. What is the procedure for cosmetic entity registration under MoCRA? The HHS secretary may suspend registration if severe adverse health effects or deaths are possible. Registrants must submit a corrective action plan for review, with facility suspension leading to restrictions on product introduction or delivery. What records must be made available under MoCRA for product examination? Records must be accessible to authorized personnel for product examination if there are concerns about product adulteration or ingredient safety. However, certain types of data, such as recipes or financial information, are exempt from review. What are the timelines for the establishment of GMP regulations under MoCRA? The HHS secretary is required to propose and finalize GMP regulations within two to three years after the enactment of MoCRA, ensuring compliance and product safety. What are the consequences of failure to comply with MoCRA registration and listing requirements? Failure to comply with registration and listing requirements may result in suspension of registration by the HHS secretary, prohibiting the introduction or delivery of cosmetic products from the suspended facility. How does MoCRA ensure transparency and accountability in the cosmetic industry? MoCRA promotes transparency and accountability by mandating reporting of adverse events, registration of cosmetic entities, and accessibility of records for product examination, thereby enhancing consumer safety and confidence. Seeking Cosmetic Compliance Help? Please complete the form below. We will respond to you soon. Company Name Contact Name E-MAIL Your phone Select all applicable Services Cosmetic NotificationCosmetic Label ComplianceFrench TranslationOther Select countries of interest CanadaUSAMexicoInternational Details Submit 0/5 (0 Reviews) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## National Drug Codes Explained [Skip to content](https://qualitysmartsolutions.com/everything-you-need-to-know-about-ndcs-national-drug-codes#content) # Everything you should Know about NDCs (National Drug Codes) National Drug Codes (NDCs) can be a confusing topic, but with the right knowledge, you can understand their purpose and use them correctly. Our regulatory consultants will help you sort out the details about NDCs, including what they mean, how to interpret them, and the regulations that come with using them. Click here to learn why [NDC Numbers have a massive impact on the pharmaceutical industry.](https://qualitysmartsolutions.com/blog/why-ndc-numbers-are-vital-for-pharmaceutical-companies/) [Speak with our Experts](https://qualitysmartsolutions.com/contact/) National Drug Codes (NDCs) are numbers issued by the FDA to identify specific drug products and packages. They are used to keep track of prescription and over-the-counter medications and can help doctors, pharmacists, manufacturers, payers, and other healthcare professionals determine what drug is being prescribed or dispensed. NDCs come in two basic formats — a 10-digit NDC or an 11-digit NDC. ![NDC](https://qualitysmartsolutions.com/wp-content/uploads/elementor/thumbs/QssCLE-Social-Media-Creatives-Additional-4-rnvgett3vu5j0r9ivz4qnz248gz2lswvocixmi5xh4.webp) ![NDC](https://qualitysmartsolutions.com/wp-content/uploads/elementor/thumbs/QssCLE-Social-Media-Creatives-Additional-5-rnvgf1bteiftlmylo2dr7x5szjy0bdqqddqtgpus3c.webp) NDCs are used to identify drug products in many different ways. For example, the 11-digit format is often used for billing purposes, while the 10-digit format can be used for ordering and reporting purposes. NDCs can also be used in electronic health records (EHR) systems to help track and compare medication use patterns. The NDC also serves as a key identifier when tracking pharmaceuticals across the supply chain. This helps ensure that medications are safe, effective, and properly labeled throughout their entire lifespan. NDC numbers are made up of several components. An 11-digital NDC number is broken down into three separate parts; the labeler code (which identifies the manufacturer), a product code, and package size. The 10-digit format eliminates the package size and count part and only includes the labeler code and product code. The length of an NDC number can vary depending on whether it is for an individual or multiple items, so make sure to double-check the format you need before using an NDC on your product labels. ![NDC](https://qualitysmartsolutions.com/wp-content/uploads/elementor/thumbs/QssCLE-Social-Media-Creatives-Additional-6-rnvgf8uix6q46inog5mrrv9hqmwy0ykl2eypaxjmpk.webp) ![Drug Identification Number Canada](https://qualitysmartsolutions.com/wp-content/uploads/elementor/thumbs/QssCLE-Social-Media-Creatives-Additional-7-rnvgfgd8fv0erecr88vsbtd6hpvvqjefrg6l558hbs.webp) All drugs and biologics that are regulated by the FDA must include an NDC number on their label, including prescription drugs, over-the-counter medicines, and medical devices. However, not all products are required to have an NDC; dietary supplements and herbal remedies do not fall under this regulatory requirement. Additionally, some non-FDA-approved substances like homeopathic medicines may be exempt from needing an NDC code. Incorrect NDC numbers can be problematic and have several implications. An incorrect code could be fraudulent, indicating that patients are receiving a counterfeit version of the product instead of the authentic version. Additionally, an inaccurate NDC may lead to insurance fraud if the product is billed against a code that doesn’t match the administered drug or biologic. Finally, incorrect use of NDCs could also create big issues with pharmaceutical data exchange centers, which are used to confirm eligibility for financial and other benefits programs. ![NDC](https://qualitysmartsolutions.com/wp-content/uploads/elementor/thumbs/QssCLE-Social-Media-Creatives-Additional-8-rnvgfmy3rp9f0o375tq6b9penezg8f4k4cqzi2yq48.webp) ## Wondering how to get an NDC Number? OTC drugs sold in the United States must be labeled with a National Drug Code (NDC). This number on a product label shows that the medicine has satisfied all quality, safety, and efficacy standards. Any firm wanting to manufacture OTCs in the United States must guarantee that their product fulfills the criteria for safety and efficacy. They should check to see whether they are in compliance with GMPs and fulfills the labeling criteria outlined in 21 CFR part 201.66. In many circumstances, satisfying FDA standards can be a complicated task. Quality Smart Solutions can assist you in precisely and effectively preparing your OTC product registration and obtaining an NDC number for your product. ![](https://qualitysmartsolutions.com/wp-content/uploads/2022/03/Drugs-Medical-Usa.jpg) Regulatory Pathways OTC Drug Monograph Application and the OTC New Drug Application (NDA) are the two processes through which every OTC Drug manufacturer or packager has to market drugs in the US market. Good Manufacturing Practices Whether you’re a domestic or foreign manufacturer or importer of OTC Drugs, you need to show evidence that you meet GMP requirements. Drug Facility Registration We'll prepare your application for establishment registration on behalf of your firm and submit it to FDA through the applicable ESG gateway. ## OTC Drug Compliance Solutions in the USA At [**Quality Smart Solutions**](https://qualitysmartsolutions.com/), we have the capability to offer assistance in all phases of the drug development and marketing process, including product development, facility registration, business planning, [**USA drug label compliance**](https://qualitysmartsolutions.com/us-drug-label-compliance/), and more. #### Did you know? Follow the Latest News, Blogs & Industry Updates [![FDA proposed rule addressing foreign drug manufacturer and distributed manufacturing registration](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/FDA-Drug-Manufacturing-Registration-300x157.jpg)](https://qualitysmartsolutions.com/news/fda-proposes-rule-to-close-registration-gap-for-foreign-drug-manufacturers/) FDA ### [FDA Proposes Rule to Close Registration Gap for Foreign Drug Manufacturers](https://qualitysmartsolutions.com/news/fda-proposes-rule-to-close-registration-gap-for-foreign-drug-manufacturers/) The U.S. Food and Drug Administration (FDA) has proposed a rule that would close a long-standing registration gap for foreign drug manufacturers, while also simplifying how distributed manufacturing ... [Read more](https://qualitysmartsolutions.com/news/fda-proposes-rule-to-close-registration-gap-for-foreign-drug-manufacturers/) Andrew Parshad July 15, 2026 [![TikTok Shop dietary supplement compliance requirements displayed on a mobile phone screen](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/TikTok-Shop-dietary-supplement-rules-300x157.jpg)](https://qualitysmartsolutions.com/blog/selling-dietary-supplements-on-tiktok-shop-a-compliance-requirements-guide/) Blog ### [Selling Dietary Supplements on TikTok Shop: A Compliance Requirements Guide](https://qualitysmartsolutions.com/blog/selling-dietary-supplements-on-tiktok-shop-a-compliance-requirements-guide/) Selling a dietary supplement on TikTok Shop sounds like a straightforward channel expansion, until your product listing gets rejected without a clear explanation. The platform ... [Read more](https://qualitysmartsolutions.com/blog/selling-dietary-supplements-on-tiktok-shop-a-compliance-requirements-guide/) Quality Smart Solutions July 13, 2026 [![Veterinary health product registration in Canada for pet health companies](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/VHP-registration-in-Canada-300x157.jpg)](https://qualitysmartsolutions.com/blog/vhp-registration-in-canada-what-pet-health-companies-need-to-know/) Blog ### [VHP Registration in Canada: What Pet Health Companies Need to Know](https://qualitysmartsolutions.com/blog/vhp-registration-in-canada-what-pet-health-companies-need-to-know/) For pet health companies planning to sell vitamins, minerals, botanicals, or other supplement-style products for companion animals in Canada, VHP registration is one of the ... [Read more](https://qualitysmartsolutions.com/blog/vhp-registration-in-canada-what-pet-health-companies-need-to-know/) Andrew Parshad July 11, 2026 [![FDA mandatory GRAS notification rule document review for food ingredient compliance](https://qualitysmartsolutions.com/wp-content/uploads/2026/07/FDA-GRAS-Notification-300x157.jpg)](https://qualitysmartsolutions.com/news/fda-mandatory-gras-notification-rule-could-reshape-food-ingredient-compliance-by-year-end/) FDA ### [FDA Mandatory GRAS Notification Rule Could Reshape Food Ingredient Compliance by Year End](https://qualitysmartsolutions.com/news/fda-mandatory-gras-notification-rule-could-reshape-food-ingredient-compliance-by-year-end/) For nearly three decades, companies introducing a new food or ingredient use into the U.S. market have had a choice: notify the FDA that they’ve ... [Read more](https://qualitysmartsolutions.com/news/fda-mandatory-gras-notification-rule-could-reshape-food-ingredient-compliance-by-year-end/) rkumar@qualitysmartsolutions.com July 10, 2026 [View More](https://qualitysmartsolutions.com/resources) Need OTC Drugs Compliance Assistance Today Please complete the form below. We will respond to you soon. Company Name Contact Name E-MAIL Your phone Select all applicable Services Medical Device RegistrationIVD RegistrationMDEL RegistrationMDL Label ComplianceOther Select countries of interest CanadaUSAMexicoInternational Details Submit 0/5 (0 Reviews) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Plain Language Labelling Compliance [Skip to content](https://qualitysmartsolutions.com/plain-language-labelling-compliance-french-translation#content) # Plain Language Labelling Compliance & French Translation Our team of experts can help make your drug labels easier to read and understand, thereby meeting the requirements of Health Canada’s [Plain Language Labeling (PLL)](https://qualitysmartsolutions.com/plain-language-labelling-compliance-french-translation/) initiative. We assure your drug labels meet the PLL format when submitted to Health Canada as part of a [Drug Identification Number (DIN) application](https://qualitysmartsolutions.com/otc-drug-compliance-din-canada/). [Get Expert Advice](https://qualitysmartsolutions.com/plain-language-labelling-compliance-french-translation#pll_compliance) [![](https://qualitysmartsolutions.com/wp-content/uploads/2021/04/pll_compn.jpg)](https://www.greatgreenwall.org/) The Great Green Wall ## Plain Language Labelling (PLL) Compliance The Plain Language Labelling (PLL) Regulations aim to ensure the safe use of drugs by making packaging and labelling easier to read and understand. This will reduce the risk to consumers who may face difficulty in reading or interpreting a drug label. The PLL Regulations put new obligations on health product manufacturers or sellers with an objective to: - Give information in plain language - Submit mock-ups of packages and labels for review - Assess their health products’ names to avoid confusion - Provide information in an easy-to-read format - Choose the standardized format to understand easily - Show how to report adverse reactions on the product’s label - Provide a Canadian Drug Facts Table (CDFT) #### Which Products do PLL Regulations Apply to? PLL Regulations apply to biologic drugs, prescription, and non-prescription pharmaceutical drugs, disinfectants, and radiopharmaceuticals. However, there are some specific requirements that only apply to subsets of these products. For instance, the CDFT requirement is only applicable to non-prescription drugs. PLL Regulations do not apply to medical devices, veterinary drugs, and drugs that are represented as being solely for use as a disinfectant on hard non-porous surfaces or natural health products. ![PLL Regulations Range](https://qualitysmartsolutions.com/wp-content/uploads/2021/04/pll_regulations.jpg) ![](https://qualitysmartsolutions.com/wp-content/uploads/2021/04/Language_labelling.jpg) #### How We Help You Meet Plain Language Labelling Regulations When a DIN application is submitted, a mock label must also be submitted. This mock label must be bilingual (English and French) and contain the correct colour, font size, and type. Labels are provided in an editable format so that Health Canada can make notes on the pdf. Our team of regulatory experts and French translators can help ensure your labels meet the necessary PLL requirements. ## Frequently Asked Questions What do the Plain Language Labeling (PLL) Regulations accomplish? These regulations attempt to improve the safe use of drugs by making drug labels and packaging easier to understand. The compliance standards impose obligations on health product suppliers to provide information in plain language, so your drug application contains the PLL format label once submitted. Its goal is to keep language simple and easy to read to reduce the risk to consumers who may face difficulty in reading or interpreting a drug label. What obligations do the Plain Language Labeling (PLL) Regulations enforce? The PLL Regulations put new obligations on health products manufacturers or sellers with an objective to: - Give information in plain language - Submit mock-ups of packages and labels for review - Assess their health products’ names to avoid confusion - Provide information in an easy-to-read - Choose the standardized format to understand easily - Show how to report harms on the product’s label - Provide a Canadian Drug Facts Table (CDFT) What products do Plain Language Labeling (PLL) Regulations apply to? PLL Regulations apply to biologic drugs, prescription, and non-prescription pharmaceutical drugs, disinfectants, and radiopharmaceuticals. However, there are some specific requirements that only apply to subsets of these products. For instance, the Canadian Drugs Facts Table (CDFT) requirement is only applicable to non-prescription drugs. What products do Plain Language Labeling Regulations (PLL) NOT apply to? PLL Regulations do not apply to medical devices, veterinary drugs, and drugs that are represented as being solely for use as a disinfectant on hard non-porous surfaces or natural health products. What is submitted with a DIN application? When a DIN application is submitted, a mock label must also be submitted. This mock label must be bilingual (English and French) and contain the correct colour, font size, and type. Labels are provided in an editable format so that Health Canada can make notes on the pdf. Need Help from PLL Compliance & French Translation Experts? Please complete the form below. We will respond to you soon. Company Name Contact Name E-MAIL Your phone Select all applicable Services Drug Identification Number (DIN) RegistrationPlain Language Labelling Compliance & French TranslationHealth Canada Pre-Submission MeetingEstablishment License (EL) RegistrationNational Drug Code Labeler Code (NDC) RegistrationUS Drug Listing (DRLS)US Drug Label ComplianceDrug Facility Registration and RenewalUS Agent Service Select countries of interest CanadaUSAMexicoInternational Details Submit 0/5 (0 Reviews) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## GRAS Press Releases [Skip to content](https://qualitysmartsolutions.com/press-releases-on-generally-recognized-as-safe-gras#content) # Press Releases on Generally Recognized as Safe (GRAS) ![](https://qualitysmartsolutions.com/wp-content/uploads/2023/08/Notified-GlobeNewswire-Color-Small.webp) \[gnw url= “https://rss.globenewswire.com/WpFeed/Language/EN/search/Generally%20Recognized%20as%20Safe/io/false/subex/cla/Content/photo/Max/10/timezone/Eastern Standard Time/dateFormat/MMM dd yyyy hh:mm” article=”inline”\] 0/5 (0 Reviews) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Clinical Trials Press Releases [Skip to content](https://qualitysmartsolutions.com/press-releases-on-clinical-trials#content) # Press Releases on Clinical Trials ![](https://qualitysmartsolutions.com/wp-content/uploads/2023/08/Notified-GlobeNewswire-Color-Small.webp) \[gnw url=”https://rss.globenewswire.com/WpFeed/Language/EN/search/clinical%20trial/io/false/subex/cla/Content/photo/Max/10/timezone/Eastern Standard Time/dateFormat/MMM dd yyyy hh:mm” article=”inline”\] 0/5 (0 Reviews) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Submission Acknowledgment [Skip to content](https://qualitysmartsolutions.com/thank-you#content) ## Thank You Your submission is received and a Quality Smart Team member will be in touch with you shortly. While you wait, find latest news and updates for Health Canada and FDA regulations. Follow us on social media to get regular updates. [Find Latest News & Updates](https://qualitysmartsolutions.com/news/) ![check (1)](https://qualitysmartsolutions.com/wp-content/uploads/elementor/thumbs/check-1-rnvifoangbzml60os73ugmedy6nsy3y4nvp3xbvb9s.webp) 0/5 (0 Reviews) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Thank You Page [Skip to content](https://qualitysmartsolutions.com/thank-you-2#content) ## Thanks for reaching out! Team Quality Smart Solutions will be in touch soon to answer your queries and help you get started on your dream project. In the meantime, feel free to browse our website or check out our latest blog posts for more insights from FDA and Health Canada.. Thanks again! Quality Smart Solutions team [Latest Blog Post](https://qualitysmartsolutions.com/blog/) ![check (1)](https://qualitysmartsolutions.com/wp-content/uploads/elementor/thumbs/check-1-rnvifoangbzml60os73ugmedy6nsy3y4nvp3xbvb9s.webp) 0/5 (0 Reviews) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## FSVP Import Agent Services ![](https://qualitysmartsolutions.com/wp-content/uploads/2021/01/logo.webp) # FSVP Import Agent: Your Gateway to Global Food & Beverages Market As an FSVP import agent, we are representatives designated by our foreign supplier clients to act on their behalf in complying with the Foreign Supplier Verification Program (FSVP) requirements of the U.S. Food and Drug Administration (FDA). The FSVP is a preventive control program that requires importers of food for humans and animals into the United States to verify that their foreign suppliers meet U.S. food safety standards. ![](https://qualitysmartsolutions.com/wp-content/uploads/2023/12/fsvp.jpg) 20+ Years of Experience 2000+ Clients Served 130,000+ Services Completed 5 Star Google Reviews ## Our Responsibilities as Your FSVP Agent SUPPLIER VERIFICATION Importers must verify that their foreign manufacturers produce food using processes and procedures that meet U.S. safety standards. HAZARD ANALYSIS Importers must analyze the hazards associated with each food product they import. This includes evaluating biological, chemical, physical, and radiological hazards. SUPPLIER REVIEW Importers must conduct an evaluation of their foreign supplier’s performance and the risk posed by the food. CORRECTIVE ACTIONS If hazards are identified, importers must take corrective actions to ensure the food is not adulterated or misbranded and, if applicable, take appropriate action to prevent recurrence. REASSESSMENT Importers are required to reassess the risk posed by each foreign supplier at least every three years, or when there is a significant change in the supplier’s production process or in the importer’s own procedures. RECORD KEEPING Importers must maintain records documenting their compliance with FSVP requirements. These records should be readily available for inspection by the FDA. QUALIFIED INDIVIDUALS Importers must ensure that individuals who develop and perform the FSVP are qualified to do so, including receiving appropriate training. IMPORTER ID Importers must provide specific information to U.S. Customs and Border Protection (CBP) when filing entries for the food, including their DUNS number, which identifies them as the importer of record. VQIP PROGRAM Importers can also participate in VQIP, a voluntary fee-based program that provides expedited review and importation of human and animal foods into the United States. ## Benefits of Using an FSVP Import Agent **Expertise:** FSVP import agents have a deep understanding of FSVP requirements and can help importers navigate the complex regulatory landscape. **Efficiency:** FSVP import agents can help importers streamline their FSVP compliance efforts, saving them time and money. **Reduced risk of non-compliance:** FSVP import agents can help importers identify and address potential compliance issues before they become problems. **Peace of mind:** FSVP import agents can help importers focus on their business operations while they handle the complexities of FSVP compliance. ![Quality Smart Solutions Launches GRAS Experts to Protect Against Food Safety Risks](https://qualitysmartsolutions.com/wp-content/uploads/elementor/thumbs/front-view-workers-with-face-mask-aquaponic-farm-sustainable-business-coronavirus-r9zxa87nhmihhl5ch2ojpwfwfcdctn4sopnlgtezkk.jpg) ## Why Choose Quality Smart Solutions as Your FSVP Import Agent? Experience The expert team of Quality Smart Solutions has experience of over two decades in working with the FDA and in helping importers comply with FSVP requirements. References We don’t speak for ourselves; our existing clients speak for us. Check our testimonials or get in touch with our clients to know us more. Check references from other importers to get our feedback. Qualifications Quality Smart Solutions has team of qualified individuals who can conduct supplier evaluations, verify foreign suppliers, and develop corrective action plans. Cost Quality Smart Solutions offers Industry’s most competitive pricing. Compare the fees of different agents with us to get the best ‘value for your money’ deal. ### Hear it from our clients ![](https://qualitysmartsolutions.com/wp-content/uploads/2021/04/goddess-garden.webp) ![](https://qualitysmartsolutions.com/wp-content/uploads/2021/04/all_one_magic.webp) ![](https://qualitysmartsolutions.com/wp-content/uploads/2021/04/kind-lips.webp) ![](https://qualitysmartsolutions.com/wp-content/uploads/2021/04/yes-to.webp) ![](https://qualitysmartsolutions.com/wp-content/uploads/2021/04/thayers-natural.webp) ![](https://qualitysmartsolutions.com/wp-content/uploads/2021/04/my-magic-mud.webp) [5 Star Google Reviews](https://www.google.com/search?q=quality+smart+solutions&rlz=1C1GCEA_enUS907US907&oq=quality+smart+solutions&aqs=chrome..69i57j69i61l2j69i60.5928j0j7&sourceid=chrome&ie=UTF-8#lrd=0x882b6108b18a51d3:0x4463c62e619af282,1,,) Our Presence - 260 PeachTree Street Northwest Suite 2200, Atlanta, Georgia, 30303, USA - 4145 North Service Rd. #212 Burlington Ontario, L7L 6A3 Canada 0/5 (0 Reviews) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Medical Equipment Press Releases [Skip to content](https://qualitysmartsolutions.com/press-releases-on-medical-equipment#content) # Press Releases on Medical Equipment ![](https://qualitysmartsolutions.com/wp-content/uploads/2023/08/Notified-GlobeNewswire-Color-Small.webp) \[gnw url= “https://rss.globenewswire.com/WpFeed/Language/EN/Industry/4535/Industry/4537/Content/photo/Max/10/timezone/Eastern Standard Time/dateFormat/MMM dd yyyy hh:mm” article=”inline”\] 0/5 (0 Reviews) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. [Privacy Policy.](https://qualitysmartsolutions.com/privacy-policy/) ## Self-Affirmed GRAS Assistance ![](https://qualitysmartsolutions.com/wp-content/uploads/2021/01/logo.webp) # Get Assistance for Self-Affirmed GRAS Compliance and Grow Your Business We guide you in deciding if Self-Affirmed GRAS status is needed for your ingredients. We also help create a Self-Affirmed GRAS dossier and ensure your ingredients meet safety standards for US market sale. Trust our team to navigate this process seamlessly for your food products’ success. ![](https://qualitysmartsolutions.com/wp-content/uploads/2023/11/maxresdefault.jpg) 20+ Years of Experience 2000+ Clients Served 130,000+ Services Completed 5 Star Google Reviews ![16388](https://qualitysmartsolutions.com/wp-content/uploads/elementor/thumbs/16388-r9zxa87ophb7bvz820vy3j79nlt34cc3v8zomp5p4g.jpg) ## What is Self-Affirmed GRAS? Self-affirmed GRAS (Generally Recognized As Safe) is a process where a company, independent of the FDA, determines the safety of their food ingredient or additive using scientific evidence and then notifies the FDA. This allows for faster market entry compared to the traditional GRAS petition process. ## Why do You Need It? In the USA, a company needs self-affirmed GRAS for a new food ingredient or additive to avoid the long and expensive traditional GRAS petition process with the FDA. It allows faster market entry while still ensuring safety through independent scientific evaluation by the company. ## Difference between GRAS and Self-Affirmed GRAS | Feature | GRAS | Self-Affirmed GRAS | | --- | --- | --- | | Submission Process | Formal petition to FDA with GRAS notification dossier | Independent determination by company | | Regulatory Oversight | High | Low | | Transparency & Public Awareness | High (FDA publishes GRAS list) | Low (no public disclosure required) | | Level of Certainty | High (FDA endorsement) | Lower (company responsibility) | | Suitable for | Complex substances, seeking high regulatory certainty | Simple substances, lower costs, faster process | ## What Makes Self-Affirmed GRAS a Better Option? ![](https://qualitysmartsolutions.com/wp-content/uploads/2021/01/Partner_img-4-3.webp) ![](https://qualitysmartsolutions.com/wp-content/uploads/2021/01/hyalogic_logo.webp) ![](https://qualitysmartsolutions.com/wp-content/uploads/2021/01/amazing_logo.webp) ![](https://qualitysmartsolutions.com/wp-content/uploads/2021/01/sapro_logo.webp) ![](https://qualitysmartsolutions.com/wp-content/uploads/2021/01/nutrawise_logo.webp) ![](https://qualitysmartsolutions.com/wp-content/uploads/2021/01/mtc_logo.webp) [5 Star Google Reviews](https://www.google.com/search?q=quality+smart+solutions&rlz=1C1GCEA_enUS907US907&oq=quality+smart+solutions&aqs=chrome..69i57j69i61l2j69i60.5928j0j7&sourceid=chrome&ie=UTF-8#lrd=0x882b6108b18a51d3:0x4463c62e619af282,1,,) Our Presence - 260 PeachTree Street Northwest Suite 2200, Atlanta, Georgia, 30303, USA - 4145 North Service Rd. #212 Burlington Ontario, L7L 6A3 Canada 0/5 (0 Reviews) We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. 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