These quality system requirements came into force on January 1, 2003. There are no regulatory quality system requirements for Class I medical devices.

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. The FDA itself acknowledged the significant impact of the change (5), including the need to train its personnel on the interpretation and best practices of ISO 13485:2016. The Medical Devices Regulations do not require importers or distributors of medical devices to have a registered quality system. ISO 13485:2016 has a 218-page guidance document with suggestions for implementation, so it’s much more tedious, bordering on prescriptive, she said. 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.

Health Canada requires medical device manufacturers to use a quality system certificate as evidence of compliance to the appropriate regulatory quality system requirement.

Iso 13485 fda