1. To market medical devices in Canada, manufacturers must classify their device according to regulations, implement an ISO 13485 quality management system with additional Canadian requirements, and obtain ISO 13485 certification from an accredited registrar.
2. Manufacturers then prepare license applications, supporting documents, and pay fees, with process times ranging from 1-8 months depending on device class.
3. Licenses must be renewed annually by meeting regulatory requirements and paying fees to avoid revocation.