Health Canada Proposes Amendments To MDEL Holders And Applicants

On November 8, 2025, the Department of Health published proposed amendments to the Medical Devices Regulations, SOR/98-282 (MDR) with a specific focus on the medical device establishment licence (MDEL) regime. The proposed amendments will have direct effects on MDEL holders and applicants in Canada due to changes to Canadian importer and foreign distributor relationships, MDEL application requirements and safety documentation requirements.

Background

Under the MDR, an MDEL permits the importation and/or distribution of medical devices in Canada. MDELs are issued to importers and distributors of all classes of medical devices (Class I, Class II, Class III and Class IV) and manufacturers of Class I devices, unless they are otherwise exempt. The proposed amendments seek to modernize the regulatory framework for MDELs by reducing unnecessary burdens and redundancies, improving Health Canada's ability to monitor risks of non-compliance from foreign suppliers and providing clarity around the interpretation of the MDR.

Summary of Proposed Changes

• Remove the requirement that foreign distributors must hold an MDEL when supplying medical devices to Canadian importers with an MDEL.
  • This amendment would not affect the requirement for Canadian importers that do not hold an MDEL to only import medical devices from foreign distributors with an MDEL.
  • This would align Canada with the frameworks of other jurisdictions that require only the importer to have a licence or registration to sell a medical device (e.g., United Kingdom, European Union and Australia).
  • In accordance with these amendments, Canada would no longer require importers with an MDEL to verify the MDEL status of subsidiary foreign distributors. This better reflects the United States' registration framework, which requires only one registration for a domestic or foreign establishment under the control of the same company.
• Require all MDEL applicants to provide supplier information within their MDEL application and to update this information annually through the annual licence review, in place of the current voluntary submission system.
  • This would aid Health Canada in their traceability efforts when responding to non-compliance and would also allow Health Canada to better monitor potential risks of non-compliance.
• Reinforce the existing requirements for manufacturers, importers and distributors to establish, implement and maintain documentation in respect of their safety management procedures by adding explicit provisions that clarify these obligations.
  • The proposed amendments would incorporate manufacturers of Class II, III and IV medical devices for consistency, even though these entities already establish, implement and maintain document procedures as part of their quality management systems certification under CAN/CSA-ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2016).
  • This amendment would reduce the number of attestations in respect of documented procedures for health and safety risk management required by MDEL holders and applicants during the licensing process.

Looking Forward

The proposed amendments, if implemented, would remove redundancies, bolster Health Canada's oversight of medical device importation and distribution in Canada and provide clarity for MDEL holders in respect of their responsibilities under the MDR.

The consultation period for these amendments is open and will close on January 17, 2026. It can be completed via the "Add a comment" function, which can be accessed throughout the Regulatory Impact Analysis Statement. If you have any questions relating to this consultation, or if you would like to discuss further, please contact one of the authors of this blog.

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