Device Registration Pathways in Canada

| 01 February 2010

In Canada, medical devices are regulated by Health Canada's Therapeutic Products Directorate and are subject to the Canadian Medical Devices Regulations (CMDR) in force since 1998, with subsequent amendments, under the Food and Drugs Act (F&D Act). The Canadian medical device program combines some of the best features of other major jurisdictions, notably the EU and US. Like the EU, risk-based classification rules incorporated into the regulations assist in assigning class and determining requirements of evolving technology, and manufacturer quality systems are reviewed by third parties. Similar to the US, publicly available databases allow visibility of products licensed by the regulator as well as licensed medical device establishments.


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