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

On this page

• Background
• Key changes in the guide
• Process to apply for an MCE
• Contact us

Background

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:

• the application process and the issuance of an electronic MCE
• how to confirm the validity of a medical device licence and authorization before submitting an application for an MCE

Key changes:

• The electronic MCE is also referred to as the Certificate of Free Sale.
• An MCE can be requested by someone who holds the authorization under the Interim Order for Class I, II, III and IV COVID-19 medical devices and who is located in Canada.
• Applicants do not need to provide additional documentation, such as a cover letter or a copy of listed licences.
• Applicants do not need to provide a notarized declaration.
• Any correspondence with Health Canada (includes submitting the form) is now done by email. The issuance of the electronic MCE is also by email. Forms submitted by regular mail will not be accepted.
• The new MCE application form is attached to the guide and features are explained.
• The request for a wet-ink signature through Global Affairs Canada has been added.

Process to apply for an MCE

To apply for an MCE, you must:

• complete the Manufacturer's certificate to export licensed medical devices from Canada/certificate of free sale form (FRM-0539)
• submit the completed form by email to mce.questions-cfe@hc-sc.gc.ca

For more information and to download the form:

• Guidance to apply for a manufacturer's certificate to export licensed medical devices from Canada (GUI-0097)
• Manufacturer's certificate to export licensed medical devices from Canada/certificate of free sale form (FRM-0539)

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.