As of January 1, 2019 the MDSAP certificate will be mandatory in order to market Medical Devices (MD) and In Vitro Diagnostic Medical Devices IVDs in Canada.

Health Canada, aware of the certificate long issue process, has announced that it will not apply enforcement action against manufacturers who demonstrate they have undergone  a complete audit in 2018, but haven’t received the relevant certificate yet.

Manufacturers who are still late and as of January 1, 2016 underwent a re-certification audit for CAN/CSA ISO 13485/CMDCAS regulation, they will now be able to transition to the MDSAP during the surveillance audit, which will enable them to keep the incurred  certification processes valid and then continue to sell their products until the MDSAP certificate is obtained.

It should be reminded that as of March 1, 2019 the CAN/CSA ISO 13485:2016 regulation will definitively replace, after a 3-year transition period, the previous 2003 version.

For more information:

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/quality-systems-13485/notice-transition-revised-version-13485-impact-compliance-quality-management-system-requirements-canadian-medical-devices-regulations.html

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/international/transition-medical-device-single-audit-program/certification-cycle-notice.html