Market Access Canada
Regulatory issues concerning medical devices in Canada is the responsibility of the Therapeutic Products Program at Health Canada.
What Institution is responsible for regulating and supervision of medical devices in Canada?
In Canada, all Medical Devices are regulated by Health Canada, Health Products and Food Branch, Therapeutic Products Directorate, Medical Devices Bureau.
How are medical devices classified in Canada?
Health of Canada uses a risk-based classification system, which classifies medical devices into the four following risk category: Class I – low risk, Class II – low-moderate risk, Class III – high-moderate risk and IV – high risk.
What are the routes of medical device registration in Canada?
There are two possible pathways for medical devices in Canada: Medical Device Establishment License (MDEL) and Medical Device License (MDL).
Manufacturers of class I medical devices can apply for Medical Device Establishment License (MDEL) by preparing mandatory procedures (QMS Procedures).
Manufacturers of medical devices classified to class II, III and IV must apply for Medical Device License (MDL). Participation of notified body in assessment procedures is required. The documents requirements for each of the device class depends of assessment procedure.
Who can register a medical device in Canada?
Foreign/domestic manufacturer can apply for MDL. Foreign/domestic manufacturers or importers of medical devices can apply for MDEL.
There is no requirement for the foreign manufacturer to appoint an Authorized Representative in Canada. However, the importer must comply with the Health Canada requirements for Good Distribution Practices (GDP).