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
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November 15, 2022
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[blog_list]
CFIA Enforcement of Nutrition Facts Table & CFIA Labeling Requirements
The Canadian Food Inspection Agency (CFIA) protects Canadians’ health and safety by ensuring food that reaches customers is safe, nutritious, and
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November 9, 2022
FSVP Compliance: Regulatory Assessment Record Keeping 2023
U.S.A RRA FDA Draft Guidance: In a recent U.S. Food and Drug Administration (FDA) draft guidance detailing its implementation
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November 7, 2022
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
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November 4, 2022
FDA NAC Warning Letter: 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
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November 2, 2022
GRAS Consultants: NDIN or FDA GRAS Certification?
Say you have a new ingredient and are ready to enter the US food market. To ensure this ingredient is
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October 28, 2022
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
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October 18, 2022
Unlock 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.
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October 11, 2022
Inside Scoop MDL VS 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
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October 5, 2022
Drug Identification Number (DIN) Unlocked Inside Scoop
Many drug industries are working in every country. To sell any OTC drug in Canada is not possible without
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September 29, 2022
FSVP Plan: Levels of FSMA-FSVP Certification
The FSVP Plan is a requirement for many companies to be FSMA compliant. It is the responsibility of the company
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September 22, 2022
How Does 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.
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September 15, 2022
Health Canada’s Regulatory Enrollment Process (REP): Top 4 things to know
Industry people and experts considering working with a company not registered with Health Canada should be aware of the regulatory
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September 9, 2022
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
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September 1, 2022
Top 6 Things to Know About NHPID and NPN
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.
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August 29, 2022
Natural Health Products (NHP/NPN) Panel Top 19 FAQs
https://youtu.be/O7GbA-Awo0g 1. What is the NHP Licensing Process/what is needed for it? This process involves the submission of a product
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August 25, 2022
SFCR License and Preventive Control Plans (PCP) Unlocked
In this blog, we’ll focus on answering your questions about the SFCR License and Preventive Control Plans, including why they
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August 17, 2022
5 reasons why Drug Identification Numbers are Important
Overview Manufacturers of prescription and non-prescription drugs are required to obtain a Drug Identification Number (DIN) before the drug product
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August 10, 2022
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)
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August 5, 2022
Unlock 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.
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June 27, 2022
Foreign Site Reference Number | FSRN Fruitful Interim Measures
Who needs a Foreign Site Reference Number (FSRN)? For Natural Health Products (NHPs) manufactured, packaged, and/or labeled by sites located
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June 16, 2022
5 Common Pitfalls When Importing Natural Health Products
As a license holder for Natural Health Products (NHPs), it is your responsibility to be aware of and educated on
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June 15, 2022
How to Classify Your Product as a Drug, NHP, or Cosmetic
Learn how to classify your product as a drug, NHP, or cosmetic in Canada. Understand key decision-making criteria, borderline examples, and what regulatory path you need to follow to stay compliant with Health Canada.
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June 9, 2022
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
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June 7, 2022
Cosmetic Ingredients: Potential Presence of Toxic Substances
What is a cosmetic? Under Section 2 of the Food and Drugs Act, a cosmetic is defined as “any substance
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May 25, 2022
Insider scoop on Selling, Importing & Registering your VHPs in Canada
Introduction: The market for animal and pet products is growing at a rapid pace. With that, there is also a
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May 18, 2022
7 Principles of HACCP: Everything you need to know before building a HACCP plan
What is HACCP? A common question that comes up in regulated industries, such as food manufacturing and processing, is “What
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May 12, 2022
Top 6 Questions to ask about OTC Drugs
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
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April 25, 2022
Learn how to differentiate Dietary Supplement vs NHP Labeling
Introduction Dietary supplements in the USA are very similar to natural health products (NHP regulations) in Canada and many products
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April 18, 2022
4 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!
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April 11, 2022
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
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March 10, 2022
Natural Health Products Quality Characterization Guide for 2022
Natural Health Products have different characterization, identification, quantification, and purity standards that you should know about to ensure the quality
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February 14, 2022
Top 10 Fruitful Medical Device Development Principles
Regulatory agencies across the globe, including the U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines
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February 9, 2022
Therapeutic vs. Non-Therapeutic Claims Classification Guide
What is a claim? A claim is a representation for sale. It can be presented as “a word, a sentence,
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January 24, 2022
How Your NHP & Drug Products are Reviewed in Canada CTA v.s NDS
In general, all drug products (including over-the-counters and biologics) must be authorized for sale by Health Canada, before they can be
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January 19, 2022
Top Components of your Class III NHP PLA
All Natural Health Products (NHPs) sold in Canada are subject to the Natural Health Products Regulations (NHPR). Natural Health Products
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January 12, 2022
11 Ways MoCRA will enhance FDA Cosmetics Regulations in 2023
Introduction: The Consolidated Appropriations Act, recently passed by the US Congress, incorporates revisions to US cosmetics laws. The Modernization of
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January 11, 2022
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
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December 24, 2021
Top 9 Cosmetic Compliance Label Components | Health Canada Cosmetics Regulations
What is a Cosmetic? Cosmetics are a part of just about everyone’s life. Every day, most of us use products
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December 17, 2021
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
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December 14, 2021
Registering Products with the EPA – What You Need to Know
The US Environmental Protection Agency (EPA) is saddled with the responsibility to register pesticides in the US. This process is
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November 29, 2021
You submitted your NPN Application what are the next steps?
What to Expect After Submitting an NPN Application In order to sell a Natural Health Product (NHP) in Canada, you
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November 19, 2021
How Pet Food VHP Labels Differ from Human Food Labels in 2022
Pet Foods and Human Food Labels are designed to look similar yet distinct. There are some similar label requirements and
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November 8, 2021
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
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October 28, 2021
How to Risk Detention of CPG at the border
The CBSA has the authority to detain consumer packaged goods at the border. QSS can help ensure there are no delays bringing your goods into Canada!
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October 25, 2021
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
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October 20, 2021
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
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October 13, 2021
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
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September 21, 2021
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
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August 20, 2021
Benefits of Using a Third-Party Auditor for Your Canna Facility
In the world of compliance and quality management, audits are a fact of life. Auditing verifies adherence to standards or
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August 11, 2021
Animal Supplements in the USA
Animal Supplements in the USA – What You Need to Know How are animal supplements regulated in the USA? Dietary
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August 2, 2021
What are the components of an NHP Label in 2023?
The product label is something we all look at in our daily lives, but not everyone is well equipped with
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July 27, 2021
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
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July 13, 2021
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,
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July 6, 2021
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
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June 3, 2021
Conventional Foods vs. Supplemented Foods
Conventional Foods vs. Supplemented Foods The easiest way to know the difference between these categories are that Conventional foods are
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April 20, 2021
The Difference between a Class I, II and III NHP Monographs Application in 2023
Introduction: Identifying the correct application type has become increasingly crucial for Natural Health Product (NHP) applications. Incorrect classification can result
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March 1, 2021
Ensuring 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.
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December 15, 2020
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,
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September 13, 2020
What is a HACCP Plan and Food Handler’s (HACCP Certification) in 2023?
HACCP Plan and the Food Handler’s Certificate are important in today’s food industry. Our experts help you navigate all food safety measures.
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April 26, 2020
Q&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
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March 22, 2020
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
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February 3, 2020
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
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January 31, 2020
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
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January 29, 2020
Regulatory requirements for Drug Identification Numbers (DIN Number Canada)
When Health Canada authorizes a drug to be marketed in Canada, a Drug Identification Number (DIN) is issued to the
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January 27, 2020
Plain Language Labelling Regulations
The label and package are the first points of interaction between a health product and a consumer. Prior to the
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January 24, 2020
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
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January 22, 2020
Illegal Marketing of Drugs and Medical Devices in Canada
Health Canada is not only the national regulatory authority for issuing health product marketing authorizations, but it also oversees and
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January 20, 2020
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
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October 12, 2018
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
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October 10, 2018
SFCR: What to expect when you’re inspected?
The Safe Food for Canadians Act (SFCA) and the Safe Food for Canadians Regulations (SFCR) are set to come into
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September 2, 2018
Do you need a license to sell essential oils? Cosmetics & NHP
When it comes to topical essential oils, determining the correct regulatory pathway to ensure full compliance typically depends on how
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August 28, 2018
Why EFSA’s 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
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August 11, 2018
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
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July 26, 2018
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
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July 11, 2018
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
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July 5, 2018
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
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June 2, 2018
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
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April 30, 2018
Business considerations: Natural Product Number Application NPN
Just a little background information first before I talk about the business aspect of capitalizing on your NPN. NPN stands
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February 19, 2018
Summary 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
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November 22, 2017
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
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August 6, 2017
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
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February 9, 2015
A 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
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March 1, 2014
