Management systems for medical device manufacturers

Canadian regulations require that medical devices be manufactured under a certified quality management system that meets the criteria of the international standard ISO 13485. The corresponding Canadian national standard is CAN/CSA-ISO 13485.

Health Canada's Therapeutic Products Directorate , in collaboration with the Standards Council of Canada, developed the Canadian Medical Devices Conformity Assessment System (CMDCAS) to address this regulatory requirement.

The Standards Council of Canada accredits organizations that certify the management systems of medical device manufacturers. Under CMDCAS, only certification bodies acredited by the Standards Council of Canada are eligible to certify a medical device manufacturer’s management system.

• Accredited certification bodies for management systems of medical device manufacturers (CMDCAS recognized) »
• Learn more about CMDCAS from Health Canada