Kanada: Aktualisierte Leitlinien zur Beantragung eines Herstellerzertifikats für den Export lizenzierter Medizinprodukte aus Kanada

Gesundheit Kanada implemented an electronic version of the manufacturer’s certificate to export on January 5, 2022 as a pilot project which is now completed and based on the success, the paper-based process is now being replaced permanently by the electronic process.

The updated guidance document provides information on the application process and the issuance of an electronic MCE. It also provides guidance on how to confirm the validity of a medical device license and authorization before submitting an application for an MCE.

Requesters of the manufacturer’s certificate to export will now be required to follow this process going forward.