Guidance to apply for a Manufacturer’s Certificate to Export licenced medical devices from Canada (GUI-0097)

From Health Canada's Regulatory Operations and Enforcement Branch

Health Canada has launched a pilot project to implement an electronic version of the manufacturer’s certificate to export (MCE). Information in this guide on how to apply is no longer accurate. Please refer to the Medical Device Establishment Licence bulletin posted January 4, 2022, for updated information on how to apply for an electronic MCE.

Important notice
An MCE can only be issued to Canadian manufacturers that hold a valid Medical Device Licence (MDL) or Medical Device Establishment Licence (MDEL).

Who this guide is for

  • Any Canadian Manufacturer looking to supply certification that their medical devices can be marketed in Canada.
  • Anyone located in Canada who plans to get an MCE in order to export medical devices from Canada to a foreign country.

In this guide

View complete guide
Download PDF (328.5KB, 14 pages)

Details and history

Published:

November 21, 2019

For assistance

Our service hours are Monday to Friday from 8 a.m. to 6 p.m. (local time) and closed statutory holidays.

By email: hc.mce.questions-cfe.sc@canada.ca

Service standards: We aim to provide the information requested by email within 15 business days. For requests that are more complicated, an estimate of the time required to answer will be provided.

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