In Canada, medical devices are categorized in four classes (Ⅰ, Ⅱ, Ⅲ, and Ⅳ) on the basis of the risks (ranging from low to high) associated with their use and the controls necessary to provide reasonable assurance that they are safe and effective. The higher the risk level, the stricter the requirements for licensing and Quality Management System (QMS).
The Canadian competent department in charge of medical devices (Health Canada, HC) is responsible for reviewing and approving license applications for devices to be marketed in Canada, during which the third-party QMS audit is required, i.e. when applying for a Medical Device License, the manufacturer of a Class Ⅱ/Ⅲ/Ⅳ device is required to submit the medical device QMS certificate issued by the third party recognized by the Canadian Medical Devices Conformity Assessment System (CMDCAS), i.e. CAN/CSA-ISO 13485 Certificate.