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Medical devices are regulated by Health Canada.
Medical devices are classified according to a risk-based model. The four classes are Class I, Class II, Class III and Class IV.
The approval process takes around 15 days for Class II devices, 75 days for Class III devices, and 90 days for Class IV devices.
Licenses issued in Canada must be renewed on a yearly basis.
An authorized representative is not required.
Last updated on February 24, 2017.
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For more information on registration in Canada, check out the following articles on our blog:
The Canadian Advantage: Influencers on the Global Regulatory Stage