On November 8, 2025, Health Canada (HC) launched a public consultation on the proposed modernization of the Medical Device Establishment Licences (MDEL), which authorize the commercialization of Medical Devices.

In anticipation of the imminent changes in the Second Phase of amendments to the Medical Devices Regulations and in order to increase predictability and transparency for the industry, Health Canada seeks to gather stakeholder opinions.

This initiative follows the First Phase of amendments, which resulted in the publication of regulations in the Canada Gazette, Part II (June 17, 2024), effective December 14, 2024. Furthermore, it is part of Health Canada’s Forward Regulatory Plan 2024-2026, which defines strategic reform interventions to make the regulatory system more effective and streamlined.

The consultation is open to all stakeholders and will remain available until January 17, 2026 (Eastern Standard Time – EST). Health Canada will take the input gathered during this process into consideration for the final publication of the documents.

Objectives

The proposed amendment focuses on three key points, explicitly indicated by Health Canada:

1. Remove the requirement for Foreign Distributors to hold an MDEL, provided they sell their Medical Devices exclusively through Canadian distributors that hold a valid MDEL.
   This change is supported by a Health Canada analysis estimating benefits for foreign distributors of $2.3 million CAD (in present value) over ten years.
2. Clarify the obligation for MDEL holders to establish, implement, and maintain documented procedures for all regulated activities.
3. Traceability: Require all MDEL applicants and licence holders to provide a list of persons (suppliers) who sell Medical Devices in Canada, with an obligation to keep it updated.

Guidance Documents Subject to Revision

Health Canada is also soliciting opinions on revisions to the following guidance documents and forms, which are integral to the MDEL system:

• GUI-0016 (Guidance on Medical Device Establishment Licensing): document defining the requirements for obtaining and maintaining the MDEL.
• GUI-0064 (Inspection Guide): document on how Health Canada inspects establishments.
• GUI-0079 (Risk Classification Guide): document on risk classification for inspections, which influences inspection frequency.
• FRM-0292 (Application Form): the MDEL Application Form and related instructions.

Conclusions and Next Steps

The second phase of amendments to the Medical Device Regulation (MDR) on Establishment Licences represents a significant step: on one hand, it reduces regulatory burdens for foreign distributors; on the other, it strengthens traceability, quality, and compliance for operators in the Canadian market.

We will continue to follow updates from Health Canada regarding the outcome of this consultation and the publication of the final regulations.

👉 We are ready to offer support on every regulatory aspect of commercializing Medical Devices in Canada: find out how.

SOURCE:

Consultation on modernizing the medical device establishment licensing (MDEL) framework – Phase II – Canada.ca