Guidance to apply for a Manufacturer’s Certificate to Export licenced medical devices from Canada (GUI-0097)
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
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
- 4. How to apply for a certificate
- 5. Certificate approval or rejection
Details and history
November 21, 2019
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