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.
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