Health Canada is a Federal department responsible for the national public health of Canadians. It regulates the use of consumer goods, drugs, biologics, medical devices, peste control and natural health products.
The approval, sale, marketing, safety and quality of medical devices in Canada is regulated by The Medical Devices Bureau of the Therapeutic Products Directorate (TPD). This is done through pre-market reviews, post-approval surveillance as well as quality systems implemented in the manufacturing of medical devices. The Food and Drugs Act and Medical Devices Regulations are the guidelines used to ensure a medical device is safe and effective.
Some of the most important regulations for medical devices in Canada are:
- Canadian Medical Devices Regulations - SOR 98-282
- ISO 13485 Audit Guidelines
- Officially Recognized CMDCAS Registrars
A full list of Health Canada regulations can be found here.
- Website: http://www.hc-sc.gc.ca/index-eng.php
Medical Device Associations in Canada: