Update: Health Canada announced that the Phase II amendments to the Medical Devices Regulations regarding establishment licences will come into force December 14, 2026, 180 days after publication in Gazette Part II on June 17, 2026. Health Canada updated the guidance documents related to medical device establishment licences in accordance with the Phase II amendments. These updated guidance documents will also come into effect December 14, 2026.
Consultation on modernizing the medical device establishment licensing (MDEL) framework
On November 17, 2025, Health Canada proposed Phase II amendments to the Medical Devices Regulations (MDR). The first phase of amendments came into force on December 14, 2024 and relate to recalls, modernizing medical device establishment licence (MDEL) application requirements, and granting the Minister of Health authority to issue terms and conditions on an MDEL.
The proposed second phase of amendments for medical devices would:
- remove the MDEL requirement for foreign distributors selling through Canadian importers with an MDEL,
- clarify that MDEL holders must maintain documented procedures, and
- require all MDEL applicants and licence holders to list suppliers of imported or sold devices.
The deadline for providing submissions on the proposed amendments is January 17, 2026. Feedback can be submitted through Canada Gazette, Part I: Regulatory Impact Analysis Statement and Regulatory Text.
Guidance on managing applications for medical device licences and adoption of International Medical Device Regulators Forum (IMDRF) table of contents
On November 21, 2025, Health Canada issued new guidance for managing applications for medical device licences, which will take effect on February 2, 2026. All applications in progress on or after that date, including reconsideration requests, will follow this guidance.
The guidance applies to the following types of medical device licences:
- new and amendment Class II applications,
- new and amendment (significant change) Class III applications,
- new and amendment (significant change) Class IV applications,
- minor change applications, and
- new and amendment private label applications.
The guidance does not apply to applications submitted under Part 1.1 of the Regulations, which are for medical devices for an urgent public health need and have their own guidance document.
On November 25, 2025, Health Canada issued guidance for preparing table of contents based medical device applications, adopting the IMDRF format to encourage and support the global convergence of medical device applications. Health Canada anticipates that the use of the IMDRF table of contents will reduce costs and timelines, enabling faster access to medical devices in Canada.
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 life sciences regulatory law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.