Health Canada medical device regulations

Health Canada medical device regulations
Health Canada medical device regulations

Health Canada medical device regulations follows a risk-based regimen for the regulation of medical devices. Reviews cover a risk assessment of the use of the device presents or could potentially present.

Medical Devices are clustered based on risk into four classes 1-4 based on risk with Class I devices presenting the lowest potential risk (e.g. a tongue depressor) and Class IV devices presenting the greatest potential risk (e.g. a pacemaker). 

Class I to IV medical devices

Class II, III, and IV medical devices have a Medical Device License to be sold in Canada, while companies selling Class I medical devices in Canada are required to have a Medical Device Establishment License (MDEL). 

Medical devices in Canada are regulated by The Food and Drugs Act (R.S.C., 1985, c. F-27) which covers food, drugs, cosmetics, and devices.

The regulation specifically for devices is Medical Devices Regulations (SOR/98-282) which includes classification, manufacturer’s obligations, associated fees, labeling requirements, establishment license, incident reporting, recalls among other requirements.

The regulations are updated often with the most recent update to the regulation was Interim Order No. 3, Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19.

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