Canadian Medical Devices Regulation (CMDR SOR/98-282)

Manufacturers intending to obtain a Medical Device License for medical devices classified as II, III, or IV are required to demonstrate adherence to the Canadian Medical Devices Regulation (CMDR SOR/98-282). Manufacturers of Class I devices that are not sold directly to the consumer must acquire a Medical Device Establishment License (MDEL). The MDEL requires companies to have documented procedures in place that meet the CMDR related to distribution records, complaint handling, recalls, incident reporting, and (as applicable) for handling, storage, delivery, installation, servicing and corrective action. Health Canada periodically inspects MDEL holders to ensure these procedures and records are maintained.