To register a medical device in the Canadian market, a quality management system must be applied for all medical devices except for class I devices. Canada has adopted ISO 13485:2003 as a Canadian National Standard and has labeled it CAN/CSA-ISO 13485:2003.

Manufacturers selling class II, III and IV devices in Canada must be registered to ISO 13485/ISO 13488 by a quality systems registrar accredited under the Canadian Medical Devices Conformity Assessment Scheme (CMDCAS).

For class II devices the quality system must satisfy the requirements for CAN/CSA-ISO 13485:2003, excluding design activities.

For class III and IV devices the quality system must satisfy the requirements for CAN/CSA-ISO 13485:2003, including design activities.

We offer a swiftly upgrade of existing 13585 QMS to the Canadian requirements. As part of our comprehensive services of medical device and IVD product registration in Canada.  For more information, please submit your inquiry or chose to consult our online expert right now.  Let's get your products registered in Canada!