Health Canada: Update on Phase 2 to Modernize Medical Device Establishment Licensing (MDEL)

By Tamara Schoyen 

In November 2025, Health Canada published in the Canada Gazette, Part I, Volume 159, Number 45: Regulations Amending the Medical Devices Regulations (Establishment Licences), its proposal to modernize the regulatory framework for Medical Device Establishment Licensing (MDEL). This was the second phase of amendments. The first phase of amendments was published in the Canada Gazette, Part II on June 17, 2024, and came into force on December 14, 2024.

Health Canada has posted information to its website “ Phase 2 of our work to modernize medical device establishment licensing” .

Key amendments in phase 2

There are three primary changes:

• Foreign distributors do not need to hold an MDEL if selling the medical devices solely through Canadian importers with an MDEL.
• MDEL holders must “establish, implement and maintain documented procedures.” MDEL holders have always been required to hold applicable procedures for compliance with the Medical Devices Regulations (SOR/98-282). Health Canada has added some clarifications around the requirements.
• MDEL applicants and holders must track the suppliers and provide a list for the medical devices imported or distributed in Canada with their MDEL application and MDEL annual license review (ALR).

Concluding remarks

The legislative changes are intended to reduce regulatory redundancy, align further with global regulations, and enhance the data on medical devices imported in Canada. 

The amended regulations will come into force December 14, 2026, 180 days after being published in the Canada Gazette, Part II on June 17, 2026.

Additional information is available from the following Health Canada resources provided below. These resources are provided for reference only at this time; they become effective December 14, 2026. 

• Guidance on medical device establishment licensing (GUI-0016) (effective December 14, 2026)
• Medical Device Establishment Licence (MDEL) application: instructions (FRM-0292) (effective December 14, 2026)
• How Health Canada inspects medical device establishments (GUI-0064) (effective December 14, 2026)
• Risk classification guide for medical device establishment inspections (GUI-0079) (effective December 14, 2026)

Health Canada will provide additional information over the next six months to raise awareness and promote compliance.