MDEL Bulletin, August 23, 2022, from the Medical Devices Compliance Program

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Background

On January 5, 2022, Health Canada launched a pilot project to implement an electronic version of the manufacturer’s certificate to export (eMCE). The intent is to replace the paper-based process once the project is complete.

Learn about the pilot project:

To assess the feasibility of the pilot project, Health Canada conducted a survey to collect feedback from industry. On May 5, 2022, we invited eMCE applicants to fill out a short questionnaire about the proposed process.

Why we’re continuing to issue electronic certificates

We are continuing to issue electronic certificates because:

  • the survey results show that industry is satisfied with the new process
  • the process is more efficient and straightforward
  • this is a more environmentally friendly way of doing business

What to expect

For the moment, we will not make any changes to the process. By the fall of 2022, we will update the online content and the guidance document, and inform industry once the updates are made.

Please continue to follow directions as outlined in our automatic email response. To obtain a copy of the fillable eMCE application form and instructions on how to fill it out, you may contact us by email at mce.questions-cfe@hc-sc.gc.ca.

Authentication and legalization

If the country of destination confirms that it will only accept the certificate if it’s authenticated by Global Affairs Canada (GAC) and legalized by the diplomatic representative in Canada, please visit the GAC’s Authentication Services Section further information and instructions.

Please follow up with GAC on the status of your authentication request by submitting an Authentication of Documents Status Request.

Contact us

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



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