Phase II of modernizing medical device establishment licensing
As we previously reported, Health Canada announced that the Phase II amendments to the Medical Devices Regulations (MDR) regarding medical device establishment licences (MDELs) will come into force December 14, 2026. Updated guidance documents regarding MDELs (linked here) will also come into force on the same date.
These amendments are intended to modernize the regulations for companies that hold an MDEL. The Phase II amendments aim to reduce burden on the industry, promote innovation and enhance competitiveness.
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; and
- requiring MDEL applicants and holders to provide a list of suppliers for the medical devices they import or distribute in Canada.
Expectations for information submitted with Class III and IV medical device licence applications
In July 2026, Health Canada released a notice to industry to clarify expectations for Class III and IV medical device licence (MDL) application content. Health Canada recently observed a significant increase in the volume of information submitted with Class III and IV MDL applications, including unnecessary information that can delay application review.
Health Canada clarified that applicants for Class III and IV MDLs should only submit the information needed to support the application and must include summaries of studies and evidence submitted. The summaries should be clear, concise, accurate and identify the information required to support a timely review. If artificial intelligence tools are used to generate summaries, the applicant must ensure the content is accurate.
Medical Devices Directorate Annual and Quarterly Performance Reports
Health Canada published the Medical Devices Directorate Performance Annual Report for April 1, 2025 through March 31, 2026 in May 2026 and the Quarterly Report for Q4 2025-2026 (January through March) in April 2026. These reports provide data on the processing times for pre-market medical device review as compared to service standards. For each class of medical devices, the reports include the number of applications received, the number of licences issued and the percentage of decisions made within performance targets.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.
The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.