Consultation on proposed amendments to the Medical Devices Regulations and Food and Drug Regulations

MDCP Bulletin, May 16, 2023, from the Medical Devices Compliance Program

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Proposed amendments

Health Canada is proposing to amend the Medical Devices Regulations and the Food and Drug Regulations to modernize the frameworks for establishment licences and recalls.

Medical Devices Regulations

We're proposing to:

The proposed amendments would deliver on the regulatory modernization commitments in the Health and Biosciences Regulatory Review Roadmap.

Food and Drug Regulations

Amendments to the Food and Drug Regulations would relate to drug establishment licences, good manufacturing practices and recall reporting.

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 April 15, 2023, and will close on June 29, 2023, 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

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