Guidance to apply for a Manufacturer’s Certificate to Export licenced medical devices from Canada (GUI-0097)
Related Services
Related guides and help
- Guidance Document on Medical Device Establishment Licensing (GUI-0016)
- Medical Devices Active Licence Listing
- Medical Devices Establishment Licence Listing
- Guidance Document - How to Complete the Application for a New Medical Device Licence
Related acts and regulations
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
- About this Document
- Guidance
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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