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

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.



Interested in obtaining fast market approval for your medical device or IVD in Canada? REQUEST A FREE QUOTE>

For more information on registration in Canada, check out the following articles on our blog:
The Canadian Advantage: Influencers on the Global Regulatory Stage
 
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