Notice: Consultation for proposed amendments to the Medical Device Regulations

MDCP Bulletin, January 7, 2022, from the Medical Devices Compliance Program

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Proposed amendments

Health Canada is proposing regulatory amendments to the Medical Devices Regulations (MDR). These amendments will deliver on commitments outlined in the Health and Biosciences Regulatory Review to modernize compliance and enforcement oversight.

The purpose of this bulletin is two-fold:

The proposed amendments for medical devices would:

The feedback we receive from the notice of intent and the survey will help to inform proposed regulatory, policy and program 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.

We are also proposing amendments to modernize the drug establishment licensing (DEL) framework as part of this regulatory package. We have engaged DEL holders in separate consultations.

Notice and survey access

The notice of intent and cost-benefit analysis survey are open for comment until February 11, 2022.

Contact us

Please email to request a survey, return your completed survey and share any additional comments:

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