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, 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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