Phase 2 of our work to modernize medical device establishment licensing
MDCP Bulletin, June 17, 2026, from the Medical Devices Compliance Program
On this page
Background
Health Canada is modernizing the regulations for companies that hold a medical device establishment licence (MDEL). We made a commitment to modernize the framework for MDELs in 2018-19, but the COVID-19 pandemic delayed this work.
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. These amendments to modernize compliance and enforcement oversight are outlined in the Forward Regulatory Plan and Stock Review Plan.
We are now in phase 2 of this modernization work, which looked at ways to reduce burden, promote innovation and enhance competitiveness.
We invited stakeholders to review the proposed amendments to the Medical Devices Regulations on November 8, 2025. The proposed amendments were pre-published in the Canada Gazette, Part I, followed by a 75-day comment period. We considered the feedback we received from stakeholders when preparing the final amendments.
Learn more:
- Canada Gazette, Part 1
- Canada Gazette, Part II
- Health Canada’s Regulatory Stock Review Plan, 2025 to 2028
- Health Canada’s Forward Regulatory Plan: 2026-2028
- Health and Biosciences Sector Regulatory Review Roadmap
About the amended regulations
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.
Key amendments include:
- removing the requirement for foreign distributors to hold an MDEL if they’re selling their medical devices through Canadian importers that have an MDEL
- clarifying the requirement that MDEL holders must establish, implement and maintain documented procedures
- requiring MDEL applicants and holders to provide a list of suppliers for the medical devices they import or distribute in Canada
Learn more:
What this means for MDEL holders
The amended regulations reduce burden for industry and clarify the regulatory requirements without compromising the health and safety of people in Canada.
They also align with international regulations and improve transparency around medical devices being imported into Canada.
We have updated the following documents to reflect the latest changes:
- Guidance on medical device establishment licensing (GUI-0016)
- Medical device establishment licence application: instructions (FRM-0292)
- How Health Canada inspects medical device establishments (GUI-0064)
- Risk classification guide for medical device establishment inspections (GUI-0079)
Note: We will replace existing guidance with these updated versions when it comes into force in December 2026.
For the next 6 months, we'll be working closely with regulated parties to raise awareness and promote compliance. We'll also be sending out bulletins on compliance promotion activities and updates on guidance documents.
Contact us
Email us if you have questions at mdel.questions.leim@hc-sc.gc.ca