Master Health Canada Regulatory Affairs

Master Health Canada Regulatory Affairs free download

Manage all regulatory activities of medical devices in the market of Canada

Master medical devices registration in the most important and biggest market ever in the world, the market of Canada, this market could be missed by any pharmaceutical or healthcare company, all the pharma industry professionals understand very well the weight of this market, how huge it is, and what is the expected revenue out of it.

Health Canada is the regulatory authority responsible for reviewing, approving, and monitoring pharmaceuticals, biologics, medical devices, and other health-related products in Canada. It ensures that drugs available in Canada are safe, effective, and of high quality.

What will you learn?

• Get introduced to Health Canada

• Health Canada portal

• Medical Devices Regulations Canada

• Medical Devices Classification Canada

• Application process

• Renewals/ variations

• The updates

  
  

In this course, we will be introduced to Health Canada’s Regulatory Pathways:

1. New Drug Submission (NDS) – Required for new pharmaceutical products.

2. Abbreviated New Drug Submission (ANDS) – Used for generic drugs.

3. Clinical Trial Application (CTA) – Required before starting human trials.

4. Biologic and Radiopharmaceutical Drug Submission (BRD/NDS) – For biologics.

5. Natural Health Product (NHP) Submission – For vitamins, supplements, and herbal medicines.

Health Canada Post-Marketing Surveillance Responsibilities:

• Canada Vigilance Program – Collects adverse drug reaction reports.

• MedEffect Canada – Provides public alerts on drug recalls and safety issues.

Health Canada is not alone in the global regulatory world; it has close collaboration with the U.S. FDA, EMA, and WHO in addition to being part of the ICH towards the global trend of harmonization.

So, from a business point of view, you can place your product in the market quite faster and start earning your revenue quite fast also, moreover, the medical devices world is highly dynamic and innovative, compared to the pharmaceuticals, with lots of innovations and different versions of the same medical device could be played within the potential market of Canada.

Dear pharma industry future professionals, let us start our interesting journey toward medical device registration in the states, we will travel together to the States, meet the health authority there "HC", and explore its requirements for registration, renewal, and variations, let us get our "HC" approval and place our products there.

In this course, we will cover all topics related to medical devices in Canada, starting from the requirements, interim regulations, classification, verification, special conditions, and weavings

And finally, congratulations to you for mastering medical device registration in the Canadian market and see you soon in the pharma industry my dear colleagues.

Let's take off to Canada

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