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A Manufacturer’s Certificate to Cover Export of Medical Devices is issued for medical devices that are legally for sale in Canada, which are intended for export to a foreign country and are currently licensed for use in Canada. The issuance of an MCE is not a regulatory requirement but rather a service to manufacturers provided by the Health Products and Food Branch Inspectorate (HPFBI), Health Canada. It 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.

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This document provides guidance on all aspects of MDELs mandated by Part 1 of the Regulations. This document also provides a reference to guidance on preparing for a regulatory inspection conducted by the Inspectorate. Distributors located outside of Canada and selling in Canada are subject to the same regulations. In addition, this document includes a section that provides guidance on how to calculate and pay fees and the fee remission process.

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