Medical Device Registration and Approval in Canada

General country-specific regulatory information is provided on this page for medical device registration and approval in Canada. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Canada, free of charge, to expedite the preparation of your medical device or IVD registration application.

Medical Device Regulations and Classification in Canada

 REGULATORY AUTHORITY: Medical devices are regulated by Health Canada.

CLASSIFICATION SYSTEM: Medical devices are classified according to a risk-based model. The four classes are Class I, Class II, Class III and Class IV.

TIMEFRAME: The approval process takes around 15 days for Class II devices, 75 days for Class III devices, and 90 days for Class IV devices.

LICENSE VALIDITY: Licenses issued in Canada must be renewed on a yearly basis.

AUTHORIZED REPRESENTATIVE: An authorized representative is not required.

Last updated on February 24, 2017.

Other North American Countries:

Mexico, United States of America

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