Consultation Opens on Proposed Changes to Medical Device Establishment Licence Requirements

On November 8, 2025, Health Canada published the Regulations Amending the Medical Devices Regulations (Establishment Licences) (Draft Regulations) in the Canada Gazette, proposing changes to the medical device establishment licence (MDEL) requirements. These changes follow Health Canada and the Public Health Agency of Canada’s Report on Red Tape Reduction (published September 8, 2025), which promised that changes to the MDEL regime would come in fall 2025 (see our earlier Blakes Bulletin).

Subject to limited exceptions, the current Medical Devices Regulations (MDR) generally require both foreign distributors and their Canadian importers to hold an MDEL. As provided in the Regulatory Analysis Impact Statement published with the Draft Regulations, industry stakeholders have raised concerns that requiring both parties to hold an MDEL creates unnecessary burdens and costs and have argued that this requirement is not aligned with other jurisdictions. Industry stakeholders have further expressed that this requirement disincentivizes some medical device companies from doing business in Canada, which ultimately affects the availability of medical devices that Canadians have access to.

The Draft Regulations remove the requirement for importers with an MDEL to import from foreign distributors with an MDEL. Persons without an MDEL that import medical devices (i.e., retailers and healthcare facilities, who are generally exempt from MDEL requirements) would continue to be required to verify that the foreign distributor from which they import holds an MDEL. This proposed amendment would more closely align Canada with other jurisdictions and reduce the redundancy in the current licensing scheme.

The Draft Regulations would also update some of the current responsibilities of MDEL holders, such as clarifying the requirement that MDEL holders must maintain certain documented procedures. MDEL applicants would also need to provide certain supplier information as part of their MDEL application and to update this information annually as part of the annual license review process.

A consultation on the Draft Regulations is now open, and will close on January 17, 2026.

For more information, please contact the authors or any member of our Health & Product Regulatory group.