Manufacturer’s Certificate to Export licenced medical devices from Canada (MCE)
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A Manufacturer’s Certificate to Export licenced medical devices from Canada (MCE) is issued for medical devices that are authorised for sale in Canada, which can also be exported to a foreign country. The issuance of an MCE is not a regulatory requirement but rather a service to Canadian manufacturers provided by the Regulatory Operations and Enforcement Branch (ROEB), Health Canada. An MCE cannot be issued for medical devices manufactured solely for the purpose of export of medical devices exempted under section 37 of the Food and Drugs Act. -(ROEB) (Medical Devices, Health Canada.)