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

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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