Consultation on modernizing the medical device establishment licensing (MDEL) framework- Phase II
Bulletin, November 17, 2025, from the Medical Devices Compliance Program
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Proposed amendments
Health Canada is proposing a second phase of regulatory amendments to the Medical Devices Regulations (MDR). The first phase of amendments was published in Canada Gazette, Part II on June 17, 2024 and came into force on December 14, 2024.
The proposed second phase of amendments for medical devices would:
- remove the requirement for foreign distributors to hold an MDEL if they are selling their medical devices through Canadian importers already holding an MDEL.
- clarify the requirement that MDEL holders must establish, implement, and maintain documented procedures.
- require all MDEL applicants and licence holders to provide a list of suppliers for the medical devices they import or sell in Canada.
The proposed amendments would deliver on the regulatory modernization commitments in the Health and Biosciences Regulatory Review Roadmap.
Consultation process
Health Canada invites stakeholders to review the proposed amendments and participate in the consultation. To provide feedback, please submit your comments through Canada Gazette, Part I:
Consultations opened on November 8, 2025, and will close on January 17, 2026, at 11:59 pm Eastern Standard Time (EST).
Health Canada will consider all feedback when we prepare these regulations for final publication in Canada Gazette, Part II.
Contact us
If you have questions, you may contact us by email at prsd-questionsdspr@hc-sc.gc.ca.