Health Canada is the federal body that regulates the drug approval process under the Food and Drugs Act (FDA) and its regulations (FDR), its related policies and guidance.
How are medical devices regulated in Canada?
In terms of statutory protections, the Canada Consumer Product Safety Act (“CPSA”) prohibits the manufacture, import and sale of products that pose a danger to human health or safety. The prohibition also extends to any advertising, packaging, or labelling that may mislead consumers as to the safety of the product.
Who regulates medical devices in Canada?
In Canada, the sale of pharmaceuticals and medical devices is regulated by Health Canada under the Food and Drug Act and Regulations and related legislation (Canadian Food Inspection Agency Act, SC 1997 c. 6; Consumer Packaging and Labelling Act, RSC 1985, c.Apr 29, 2019
Medical Devices as defined and regulated by Health Canada:
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices.html
