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Health Canada requires medical device manufacturers to use a quality system certificate as evidence of compliance to the appropriate regulatory quality system requirement. Health Canada will only accept quality system certificates that have been issued by special third party auditing organizations called Canadian Medical Devices Conformity Assessment System (CMDCAS) recognized registrars. The Medical Devices Regulations do not require importers or distributors of medical devices to have a registered quality system.

The Medical Devices Regulations require class II, III and IV medical devices to be manufactured (class II) or designed and manufactured (class III & IV) under CAN/CSA ISO 13485:2003. There are no regulatory quality system requirements for Class I medical devices. These quality system requirements came into force on January 1, 2003.

Establishment licence and Problem  reporting

Any person who imports into Canada, or sells in Canada, a medical device for human use requires an establishment licence. Mandatory and Voluntary Problem Reporting for Medical Devices are strictly regulated.


Regulations state  that no person shall import or sell a medical device unless the labelling of the device bears the information described in that section. In order to comply with the Regulations, it is sufficient that a licence holder has a procedure in place to ensure compliance with this labelling requirement for the medical devices they import or sell. Class I medical devices do not require licensing but must comply with the labelling requirements