How Drug Registration Works in the U.S. and What NDC Numbers Mean
Learn how drug registration works in the U.S. and why the National Drug Code (NDC) number matters for compliance, billing, and patient safety.
... Read moreNavigating the Regulatory Seas: How Experts Ensure Your Medical Devices Set Sail Smoothly
Introduction In the ever-changing world of medical device manufacturing, ensuring your product complies with regulations is akin to navigating stormy seas. The safety of patients, the assurance of quality, and the complexities of compliance weigh heavily on manufacturers. This article sheds light on the challenges faced and how expert navigators—regulatory consultants—play a pivotal role in
... Read moreA Clear Guide to FDA 510(k) Submission Requirements
Introduction In the world of medical devices, ensuring patient safety and efficacy is paramount. The 510(k) submission process is a critical step for manufacturers seeking clearance from the U.S. Food and Drug Administration (FDA) to market their devices. This process can be complex, but it plays a pivotal role in bringing innovative medical devices to
... Read moreNavigating French Language Labeling Requirements in Canada: A Guide for Food Manufacturers
Introduction: As a food manufacturer in Canada, ensuring that your product labels comply with Health Canada’s regulations is crucial for successful market entry and consumer safety. For businesses looking to distribute food products in Canada, one essential aspect is adherence to bilingual labeling requirements, notably including French alongside English on product labels. In this blog,
... Read moreWhy is it crucial to avoid FDA Warning Letters for dietary supplements and health products?
As a business owner operating in dietary supplements and health products, you are undoubtedly aware of the ever-evolving regulatory landscape. Ensuring that your products meet the stringent requirements set forth by the U.S. Food and Drug Administration (FDA) is not merely a matter of legal obligation; it’s imperative for your brand’s success and consumer
... Read moreEverything businesses should know about submitting a 30-Day Pre-Market Notification and Structure-Function Claims
https://youtu.be/MlufAYFqQ1s In dietary supplements, navigating the intricate regulatory landscape is a challenging yet indispensable aspect of launching your product. Submitting a 30-day Pre-Market Notification and Structure-Function Claim to the U.S. Food and Drug Administration (FDA) is a pivotal regulatory requirement. This notification must be submitted at least 30 days before introducing your dietary supplement to
... Read moreHealth Canada’s Notice Enables the Use of L-alpha Glycerylphosphorylcholine in Supplemented Food
Health Canada Approves Alpha GPC in Foods On September 20, 2023, Health Canada approved the use of L-alpha-glycerylphosphorylcholine (alpha GPC) as a supplement in foods. This decision followed a thorough safety review by Health Canada’s Food Directorate. How Health Canada Administers Foods and Food Supplements Health Canada ensures food and drug safety is maintained in
... Read moreNavigating Cosmetic Product Regulations through FDA Recent MoCRA Update
https://youtu.be/uuXA8yHrrZc Introduction: In response to the FDA’s recent draft guidance on the Registration and Listing of Cosmetic Product Facilities and Products, we’ve got some updates and insights that might interest you, especially if you’re in the cosmetic business. First, nearly 50 public comments were submitted to the FDA regarding this draft guidance by the September 5,
... Read moreSelling Your Food Products in the USA: A Guide for Food Business Owners
https://youtu.be/x4c0LEPmJuM If you’re selling food products in the United States, understanding and complying with FDA regulations is non-negotiable. The Food and Drug Administration (FDA) has established rigorous requirements to ensure the safety and transparency of food products available to consumers. Here’s a practical guide tailored to food business owners on ensuring your food products meet
... Read moreHow to Obtain an NPN License for Your Natural Health Product in Canada
Learn how to obtain an NPN license for your natural health product in Canada with these simple steps. Stay compliant with Health Canada regulations.
... Read moreHow to prepare and submit an eStar 510k Submission as of October 1st
Introduction: Staying up-to-date with the latest regulations and tools is crucial in medical device submissions. As of June 9, 2023, the FDA introduced the electronic Submission Template and Resource (eSTAR) for Pre-Submissions, revolutionizing the process for medical device applicants. Starting October 1, 2023, all 510(k) submissions, unless exempted, must be submitted electronically using the eSTAR template.
... Read more10 Steps to Sell Dietary Supplements in the U.S.
Learn how to legally sell dietary supplements in the U.S. by following FDA regulations, labeling requirements, and ingredient safety standards. Stay compliant and grow your business.
... Read moreUnderstanding FSVP Rules and How to Stay Compliant
For importers in the global food trade, ensuring the safety and compliance of imported products is a top priority. The Foreign Supplier Verification Program (FSVP) is vital to this effort, requiring importers to adhere to specific rules and meticulously maintain accurate records. In this article, we’ll delve into everything importers need to know about FSVP
... Read moreWhat the Draft Guidance Means for MLMD Applications
Discover the secrets behind successful Machine Learning-Enabled Medical Device (MLMD) development, risk management, and more.
... Read moreHow FSMA Strengthens Food Safety Compliance
The Food Safety Modernization Act (FSMA) Made Simple Imagine a world where preventing food-related illnesses is more important than dealing with them after they happen. That’s precisely what the FSMA, introduced in 2011, aims to achieve. The FSMA focuses on stopping contamination and illnesses before they occur, covering various stages of the food supply chain,
... Read moreFSVP Planning: Everything you should know before choosing an FSVP Agent for Import/Export
https://youtu.be/T3pLp1dF08Y Introduction: In the intricate world of global trade, ensuring the safety and compliance of imported and exported food products is a shared responsibility. The Foreign Supplier Verification Program (FSVP) stands as a cornerstone in this effort, safeguarding the well-being of consumers and the integrity of the food supply chain. When navigating the FSVP landscape,
... Read moreStaying Ahead of the Game: Key Insights on the Latest Requirements for New Drug Submissions
From FDA guidelines to global regulatory standards, understanding the nuances of each requirement is essential to ensure a timely and successful drug submission. Our experts have analyzed the latest updates and compiled a comprehensive guide to help you stay ahead of the curve. In the dynamic and highly regulated world of pharmaceuticals, staying ahead
... Read moreDemystifying GHP and GMP Regulatory Food Safety Audits: Why They Matter
In the realm of food production and processing, safety is paramount. Ensuring our food is free from contaminants and meets stringent quality standards is a shared responsibility. This is where Good Hygiene Practices (GHP) and Good Manufacturing Practices (GMP) come into play. This comprehensive guide will explore the significance of GHP and GMP regulatory food
... Read moreNavigating the FDA Registration 510K Process: Your guide to getting your Medical Device to market
Introduction: So you’ve got a game-changing medical device that could reshape healthcare as we know it. Amazing! But before making that impact, you must navigate the labyrinth of FDA regulations and registrations, specifically the 510(k) pathway. In this guide, we’ll break down the process in a relatable way, covering everything from FDA regulations to
... Read moreNavigating HACCP Regulations: A Comprehensive Guide for Industry Compliance
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 is where HACCP – Hazard Analysis and Critical Control Points – takes center stage. It’s not just a buzzword; it’s a systematic approach that safeguards products and instills consumer trust. Let’s delve into the depths
... Read moreAAFCO Membership Approves New Pet Food Regulations for Enhanced Transparency and Consistency
Introduction In a groundbreaking move, the Association of American Feed Control Officials (AAFCO) has given the green light to an extensive overhaul of pet food and specialty pet food regulations. This decision is set to transform the way pet owners perceive and choose pet food products, marking a significant shift after more than four decades. With an
... Read moreIOR Compliance USA: Navigating Regulations and Tax Responsibilities
https://youtu.be/mWaBQzsa1_M Introduction: Navigating international trade regulations and the intricacies of Importer of Record (IOR) compliance and taxes can be complex. This comprehensive guide breaks down IOR compliance and its connection to tax obligations in the USA, offering a clear understanding for businesses engaged in global trade. IOR Compliance USA: Connecting Regulations and Tax Responsibilities What
... Read moreDecoding Food Labeling Regulations: Unveiling Requirements on Food Labels
Understanding Food Labels: A Simple Guide Food labels are more than just ingredient stickers on packaging; they are a key tool that helps consumers make informed choices about what they eat. This guide simplifies the complex world of food labeling regulations, focusing on the rules set by Health Canada, the U.S. Food and Drug Administration
... Read moreDel 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 in Canada. This organization plays a vital role in protecting the health and well-being of Canadians by setting standards, conducting research, and enforcing regulations. In this guide, we’ll explore the responsibilities and functions of Del
... Read moreEverything you should know about Health Canada Controlled Substances
Health Canada, the Canadian federal health department, oversees the regulation of controlled substances in Canada. Controlled substances are regulated due to their potential for abuse, dependence, and public health and safety harm. They include drugs and substances that are categorized into different schedules based on their level of risk and potential for misuse. In Canada, controlled substances are
... Read moreNew CFIA regulatory responsibilities regarding caffeinated energy drinks
The Canadian Food Inspection Agency (CFIA) has regulated food products for many years, with a particular focus on the safety of Canadians. This includes ensuring products are packaged, labeled, and advertised by government regulations and guidelines that set standards to protect the health and safety of consumers. In response to an increasing number of consumer
... Read moreQuality Management Systems (QMS): Impact of Quality Assurance & Quality Control
Quality Management Systems (QMS) are an essential part of the life sciences healthcare industry, and many people need clarification on what a Quality Assurance person is. The FDA and ISO 9000 mandate quality processes, including quality assurance (QA) and quality control (QC) in medical devices, pharmaceuticals, and other sectors. They are crucial to regulated businesses since
... Read moreYour comprehensive guide to GRAS Applications for peak efficiency and success
Are you ready to take your business to new heights? Look no further. In this comprehensive guide, we will unlock the potential of GRAS applications to help you achieve peak efficiency and success. Whether you’re a small startup or an established enterprise, understanding the power of GRAS (Generally Recognized as Safe) applications is essential for
... Read moreEverything you should i know about Health Canada product monographs
Health Canada publishes product monographs to describe a product’s health risks, benefits, and performance. Product monographs are for health products licensed by Health Canada and those approved by the Natural Health Products Directorate (NHPD). A product may appear on the market without a product monograph being written. A manufacturer is responsible for ensuring that the
... Read moreHealth Canada MDALL Medical Device Registration Guide
Learn how Health Canada’s MDALL works and what you need to register your medical device in Canada.
... Read moreHow the GRAS List Works for Food Additives
Learn how the GRAS list ensures food additive safety and how to get your ingredient listed. Stay compliant with FDA regulations.
... Read moreHow to Get a Medical Device Establishment Licence in Canada
Learn how to get your Medical Device Establishment Licence faster and stay compliant with Health Canada.
... Read moreHow Manufacturers Can Register With the FDA
Are you running a business that deals with food, drugs, medical devices, cosmetics, or dietary supplements? If so, you must know the FDA establishment registration requirements to ensure your products meet legal standards and are safe for public consumption. The process of FDA establishment registration may seem daunting, but with the proper guidance, it can
... Read moreWhat to Ask When Registering a Food Facility With the FDA
Get the inside regulatory scoop on FDA food facility registration including submitting information, handling food products, and more.
... Read moreHow to Achieve GRAS Status for Your Ingredient
Learn the FDA process to achieve GRAS status for your ingredient and ensure it meets safety and compliance requirements.
... Read moreWhat Businesses Need to Know About FDA NAC Guidelines
We explore the FDA safety guidelines for NAC Supplements including marketing/labeling and utilizing FDA resources for guidance.
... Read moreYour Complete Guide to Getting HACCP Certification
Learn what HACCP certification is, why it really matters, and how to get HACCP certified to protect and grow your food business.
... Read moreUnlock 7 Steps to Verifying Your FSVP in 2023
The following are seven steps for businesses that want to get their FSVP certification. Follow our FSVP checklist to ensure timely results.
... Read moreNHPID and NPN: 6 Key Things Businesses Should Know
If you’re selling natural health products in Canada, understanding NHPID and NPN is essential. These tools from Health Canada determine whether your ingredients are acceptable and whether your product is eligible to be sold legally.
... Read moreUnlock Food Regulations for Food Sales Health Canada & FDA
Save time & money by learning food regulations for food sales in North America including food facility registration, TMAL, FSVP, and more.
... Read more4 Tips on How to Complete Your Cosmetic Notification Form
Cosmetic Notification Forms Must be Completed Accurately For Quick and Efficient Processing by Health Canada. Work with QSS Today to File Your Notifications!
... Read moreHealth Canada Marketing Authorization Update – Increased Vitamin D
Health Canada Announced a Marketing Authorization (MA) to Permit Increase in the Amount of Vitamin D in Cow’s Milk, Goat’s Milk and Margarine.
... Read moreMDSAP: 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 a Medical Device Licence (MDL) for each product they sell. In order to obtain an MDL you need an ISO 13485 certificate that has been issued through the Medical Device Single Audit Program (MDSAP). These
... Read morePublic 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, medical devices and natural health products (NHPs). The purpose of these changes is to improve the speed at which these trials are approved, to avoid stifling medical advances that could help improve the health of
... Read moreCancellation 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 issued a bulletin about cancellation of Medical Device Establishment Licence (MDELs) for the sites that are not compliant with the annual licence review requirements. About 700 MDEL holders have not submitted an annual licence review
... Read moreInterim 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 medical devices for use in relation to COVID-19. Interm Order No. 2 will continue to issue expedited authorizations for the sale or import of medical devices to deal with the current significant risk of COVID-19
... Read moreFDA’s 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 industry will have roughly two years to incorporate labeling changes to accommodate this new requirement. This clear labeling initiative is warranted to improve transparency, reduce allergic reactions, and protect this vulnerable population. Prevalence: Sesame allergies
... Read moreWhy 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 Health Products Regulations (NHPR) and must be licensed prior to marketing in Canada. Licensed NHPs are assigned an eight (8) digit Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM). To be classified as an NHP,
... Read moreConventional vs Supplemented Foods: Understanding the Differences in Canada and the USA
Learn the key differences between conventional and supplemented foods under Health Canada and FDA rules and how to stay compliant.
... Read moreNNHPD Monographs: Difference Between Class I, II and III Applications
Learn the difference between Class I, II and III NNHPD monographs applications and how they impact NHP licensing in Canada.
... Read moreValidation of the Safe Food for Canadians Licence to Import
In order for food that is regulated under the Safe Food for Canadians Regulations, to be imported into Canada, the importer must hold a valid Safe Food for Canadians (SFC) license. This license is issued by the Canadian Food Inspection Agency (CFIA) and must be presented with the shipment at the border in order for
... Read moreEnsuring Predictability for Interim Orders Relating to COVID-19
Health Canada’s notice on interim orders relating to COVID-19 and medical devices acknowledging stakeholders require predictability for regulatory aspects.
... Read moreQ&A: Selling Hand Sanitizers in Canada
With the need for hand sanitizers significantly increasing for healthcare personnel and individuals during the current COVID-19 pandemic do help prevent and reduce the spread of the coronavirus Health Canada is taking action with interim measures to increase the supply of these products. This post is to help answer questions related to these actions and
... Read moreForeign 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 (FSVP) in May 2017. FSVP (Foreign Supplier Verification program) requires U.S. importers (regulated by US FDA) to verify that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards. Similar to the
... Read moreNatural 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 us know firsthand there is a difference between what the marketing team wants to say and what the regulatory authorities will let you get away with. Consideration needs to be taken to ensure your brand
... Read moreAmazon.ca removing non-compliant Natural Health Products in October
In September Amazon.ca notified every Natural Health Product vendor (whether they had an NPN or not) that, effective in October 2018 they will be removing all products that don’t have a Natural Health Product Number. Here’s the email they sent to sellers: AMAZON NOTICE TO SELLERS OF NATURAL HEALTH PRODUCTS Dear Seller, Pursuant to Canadian
... Read moreWhat Every Business Should Know About NPN Applications
Just a little background information first before I talk about the business aspect of capitalizing on your NPN. NPN stands for Natural Product Number. It is a license that is issued by Health Canada and required for a dietary supplement (the term used in Canada is Natural Health Product) to legally be sold in Canada. The
... Read moreSummary of the Proposed Approach to the Regulation of Canna
On November 21, 2017 the Canadian Minister of Health announced the Proposed Approach to the Regulation of Canna. The public consultation 60-day period has begun for feedback on the proposed rules which are primarily to layout the framework and regulations around recreational marijuana with medical marijuana rules, for the most part, being status quo. The
... Read moreCanada Natural Health Product (NHP) Labelling Revision Update for Products Containing Green Tea Extract (GTE)
On November 14, 2017 the Natural and Non-prescription Health Products Directorate (NNHPD) announced that there are several updates to the NHP Monograph for Green Tea Extract based on reports from Canada and worldwide that there may be a link, albeit the risk is rare, of the use between green tea extract and risk of a
... Read moreFDA proposes extended dates for Nutrition Facts and Supplement Facts labels compliance
This past June 2017 the Food and Drug Administration (FDA) put a hold on the compliance dates for Nutrition Facts and Supplement facts compliance dates. The compliance dates were scheduled for July 26, 2018 for companies with annual sales over $10 million and July 26, 2019 for companies with sales over $10 million. Scott Gotlieb
... Read moreChanges to Regulation of Veterinary Health Products (VHP) in Canada
We can help you meet Health Canada’s VHP requirements including compliant labelling and VHP notifications. Contact us today for your VHP compliance needs.
... Read moreImport Solutions for Natural Health Products – Our New Website!
Our sister company, Quality IMPORT Solutions has a new website with all the information you need to make an informed decision when choosing an importer for your natural health products and what makes Quality IMPORT Solutions different than other providers. You visit the site at www.qualityIMPORTsolutions.com.
... Read morePLL – 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 Act (F&DA) underwent drastic revision after the thalidomide crisis of the 1960s. While some amendments have been introduced since then, the F&DA has remained mostly untouched. In 2014, the Regulations Amending the Food and Drug
... Read moreTop 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 United States. There are, in fact, several distinct differences. As you plan to enter the Canadian market there are several points to consider. You need to obtain a Natural Product Number (NPN). This
... Read moreA New NHPD Ingredient Database Monograph Coming Soon?
Health Canada recently announced their initiative to modernize the regulatory framework for health products and foods. This is required due to a variety of factors, such as new and emerging science breakthroughs and public health threats worldwide. The modernization is also based on public input regarding the need for greater transparency. The Canadian federal government
... Read moreKeeping An Eye On The Global Health Products Landscape
Significant changes are occurring in the global regulatory landscape as of late, and this is just another example of how the world is evolving into a single global marketplace. Products marketed in the United States may be in Brazil after having cleared the regulatory hurdles of that country. Products made in Korea may be in
... Read moreThank you for visiting us at the NATURAL PRODUCTS EXPO WEST in Anaheim, California in March!
We hope you found it as successful as we did. Feel free to email us at info@qualitysmartsolutions.com or give us a call at 1-800-396-5144.
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