In Canada, medical devices, including commercial in vitro diagnostic devices, are regulated by Health Canada, a department of the federal government, pursuant to the Food and Drugs Act [1] and the Medical Devices Regulations [2]. Within Health Canada, the Medical Devices Bureau, a division of the Therapeutic Products Directorate, serves as the national authority for monitoring and evaluating the safety, effectiveness, and quality of diagnostic and therapeutic medical devices before being authorized for sale in Canada. The Therapeutic Products Directorate ensures, to the extent possible, the safety, effectiveness, and quality of medical devices in Canada by a combination of premarket review, post-approval surveillance and documentation of quality systems in the manufacturing process. Under the Medical Devices Regulations all devices must meet safety and effectiveness requirements and must have a compliant label before they can be imported into, advertised, and/or sold in Canada.

Canada manufactures relatively few in vitro diagnostic devices. The majority of in vitro diagnostic devices used in the country are imported from manufacturers in the United States and Europe. Under the North American Free Trade Agreement (NAFTA), certain products, including most medical devices, that originate in Canada, Mexico, or the United States enjoy low or zero tariff rates when traded between these countries. In order to receive this preferential treatment, products that qualify must have a NAFTA Certificate of Origin.

In Canada, medical devices are assigned to one of four classes by the Therapeutic Products Directorate based on the risk associated with their use (Canadian Risk-Based Classification System). Class I (e.g., a thermometer, prepared bacterial culture media) medical devices are of lowest risk and Class IV (e.g., pacemakers, HIV diagnostics) are the highest risk. Prior to selling a device in Canada, manufacturers of Class II, III and IV devices must obtain a Medical Device License. Class I devices do not require a Medical Device License but are monitored by Health Canada through Medical Device Establishment Licenses which allow importers, distributors, and manufacturers of Class I devices, who do not sell their products through a licensed importer or distributor, to operate in Canada. In general, Class II devices require that the manufacturer only attest to having safety and efficacy data on file; no premarket review is required. Following submission of a Medical Device License Application to Health Canada the length of review varies depending on the class of the device; Class III and IV license applications have a target review time of 75 days and 90 days respectively, and Class II license applications have a 15 calendar day target.

Canadian regulations require that medical devices be manufactured, or designed and manufactured, under a registered quality management system that meets the criteria of the Canadian National Standard CAN/CSA ISO 13485:03 Medical devices – Quality Management Systems – Requirements for Regulatory Purposes