What Are The Differences Between FDA And Health Canada

What Are The Differences Between FDA And Health Canada?

Posted on : 11/15/21 Posted by :

The FDA and Health Canada are regulatory authorities in Canada and the USA, intended to control the manufacturing and supply of drugs and medical devices. For any manufacturer, it is a must to comply with the regulatory requirements given by these authorities. The regulations apply to packagers, labelers, lab testers, distributors, importers, and wholesalers. Read on the article to know the main differences between FDA and Health Canada regulatory bodies.

What Is FDA?

FDA is the abbreviation for Food and Drug Administration, which is one of the important regulatory bodies in the USA. FDA has made some regulations that should be maintained by the manufacturers or distributors, or wholesalers who intend to launch their product in the USA market.

Health Canada

Suppose you are a manufacturer of medical devices or goods and seeing to market them in North America or Canada. In that case, you need to take permission from Health Canada regulatory body. As a manufacturer, you need to comply with all the rules and regulations and make your sales process move on smoothly.

Differences Between FDA And Health Canada

The main difference between FDA and Health Canada is the requirement of medical device approval, ISO, and reviewer discretion. Here are some of the differences

1. Classification

FDA in the USA divides medical devices into three groups based on the risk levels. Class I devices include the lowest risk and are exempted from the regulatory process, and medical devices such as wheelchairs come under class II. In contrast, Class III medical devices consist of higher-risk devices such as pacemakers or implants and constitute just 10% of the devices regulated by the US FDA.

Health Canada has four classifications of medical devices according to the risks, and the classification is Class I to IV. The rules of classification are slightly different from that of the FDA. They involve using criteria such as invasiveness, reliance on an energy source, or potential contact with a patient’s nervous or cardiovascular system.

2. Application Fees

FDA has an extensive list of fees for getting approval in the market. The fees include pre-market approval, Product Development Protocol, Post Marketing Requirements, and Biological License Applications. The annual establishment fee is not included, while small and medium-sized businesses have the option to get an exemption.

For Health Canada, class I medical devices are exempted from fees, while other classes have to pay fees based on the medical devices that are manufactured or imported. The fees for various classes are defined as

  • License Application Fee of $414 Canada Dollars for Class II
  • License Application Fee of $5922 Canada Dollars for Class III
  • License Application Fee of $ 13770 Canada Dollars for Class IV

3. Clinical Investigations

FDA requires the companies undertaking clinical trials to compile with following regulations

  • Electronic Signatures
  • Informed Consent
  • Financial Disclosure
  • Institutional Review Boards
  • Investigational Device Exemptions

On the other hand, Health Canada expects the manufacturers to confine to Good Clinical Practices for the clinical investigation of medical devices on humans. With very few exemptions, ISO 14155 is considered as Canadian Regulations by all the manufacturers.

4. Reviewer Discretion

FDA has made many regulations to fix issues following complaints from medical device manufacturers about how hard it was to obtain approval. The public wanted the devices to be manufactured faster with more streamlined access to various products. FDA has appointed a team to look into the matter, and the main goal of the review team is to make devices available to the general public.

In Health Canada, the regulation was introduced in 2008, and there have been many changes made in these 20 years. The laws closely work with ISO 13485 with some precise tweaks around approvals, required safety data, and timelines for reporting issues in the field.

Meeting The Regulations In Canada

While there are many common things between FDA and Health Canada, there are also significant differences between FDA and Health Canada. The Canadian market is smaller than that of the USA, so the laws are structured very differently. Knowing the specifications and requirements is important if you are a manufacturer and trying to get into the Canadian market. One should enable the organization to meet various requirements, including all the ISO certifications.


As a manufacturer and distributor of medical devices, Protech Safety Supply has always followed the rules and regulations of the Health Canada regulatory board. If you are a distributor looking for masks and other medical equipment, please contact Protech Safety Supply. Contact us for more details.

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