Notice: Consultation for proposed amendments to the Medical Device Regulations

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

On this page

• Proposed amendments
• Considerations
• Notice and survey access
• Contact us

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:

• advise Medical Device Establishment Licence (MDEL) holders of the notice of intent published on December 11, 2021
• request their feedback on the cost-benefit analysis survey

The proposed amendments for medical devices would:

• streamline MDEL application requirements to reflect current practices
• provide the Minister with new and expanded authorities over MDELs, including the ability to issue terms and conditions on an MDEL and partially suspend or cancel an MDEL to mitigate risks to health and safety
• implement ministerial authority to order recalls of medical devices, harmonize the definition of a recall and clarify industry reporting obligations in guidance

The feedback we receive from the notice of intent and the survey will help to 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.

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

• notice of intent
• cost-benefit analysis survey

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: prsd-questionsdspr@hc-sc.gc.ca.