Updated guidance on how to apply for a manufacturer's certificate to export (MCE)

MDEL Bulletin, January 18, 2023, from the Medical Devices Compliance Program

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Remote working conditions implemented at the start of the COVID-19 pandemic meant that Health Canada could not process paper-based requests for a manufacturer's certificate to export (MCE).

We implemented an electronic version of the MCE on January 5, 2022.

We have now completed this pilot project. Based on its success, we are replacing the paper-based process with the electronic process permanently.

We have updated the Guidance to apply for a manufacturer's certificate to export licensed medical devices from Canada (GUI-0097) to reflect the new process.

Key changes in the guide

The updated guidance document provides information on:

Key changes:

Process to apply for an MCE

To apply for an MCE, you must:

For more information and to download the form:

Contact us

If you have questions about an electronic MCE or the application process, please contact the Medical Device Establishment Licensing Unit at mce.questions-cfe@hc-sc.gc.ca.

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