Notice of Intent: Consultation on modernizing the medical establishment licensing framework (Phase II)
MDCP Bulletin, November 21, 2024, 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 will be coming into force on December 14, 2024. These amendments will deliver on commitments outlined in Health Canada's 2024-2026 Forward Regulatory Plan (FRP) and Stock Review Plan (SRP) to modernize compliance and enforcement oversight.
The purpose of this bulletin is to advise Medical Device Establishment Licence (MDEL) and Medical Device Licence (MDL) holders of the notice of intent published on November 9, 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 distributors already holding an MDEL.
- clarify the expectation that MDEL holders need to establish, implement, and maintain documented procedures.
- require all MDEL applicants and licence holders to provide a supplier list of "persons" selling into and within Canada.
The feedback we receive from the notice of intent will help inform proposed regulatory, policy and program considerations.
Considerations
Health Canada is taking a phased approach to modernizing the MDR to address your feedback. Amendments would strengthen our ability to provide efficient, effective and agile oversight of medical devices in Canada.
Notice access
The notice of intent is open for comments until December 9, 2024.
Contact us
If you have any questions please email: prsd-questionsdspr@hc-sc.gc.ca.
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