Health Canada: Structure and Overview

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, 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 and 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.

A list of Health Canada regulations can be found here on our website.

Contact details:

• Website: http://www.hc-sc.gc.ca/index-eng.php

Medical Device Associations in Canada:

• BioAlberta
• Canadian Association of Professional Regulatory Affairs (CAPRA)
• LifeSciences British Columbia
• Medical Devices Canada (MEDEC)