Health Canada reviews medical devices to assess their safety, effectiveness and quality before being authorized for sale in Canada, under the Canadian Medical Devices Assessment System (CMDCAS). The level of regulatory scrutiny to be applied is based on risk management principles that use a rule-based system to classify medical devices into four classes, with Class I representing the lowest risk and Class IV the highest. Here are some examples of devices relating to product classification.
To sell a medical device in Canada, manufacturers must meet the regulatory requirements as defined in the Medical Devices Regulations. Class I medical devices offered for sale in Canada do not require a medical device licence and are monitored through Establishment Licensing. Class II, III, and IV medical devices offered for sale in Canada require a medical device license. To successfully apply for a medical device license the manufacturer must submit supporting documentation to demonstrate its safety and effectiveness. Regulations also require that the manufacturers of class II, III and IV devices design and manufacture their products under a registered quality management system (QMS) that meets the criteria of the international standard ISO 13485: 2003. These manufacturers must have their QMS registered by a Registrar accredited to the CMDCAS scope.