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:
- update the definition for "recall" to include recalls ordered by the Minister
- establish a regulatory framework for recalls of medical devices ordered by the Minister
- clarify industry's reporting and record-keeping obligations for recalls that they initiate
- align the reporting of low-risk medical device recalls with that of international regulatory agencies
- modernize the medical device establishment licence (MDEL) application requirements to reflect current practices
- give the Minister the ability to issue terms and conditions on an MDEL to mitigate risks to health and safety, and strategically target non-compliance
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 prsd-questionsdspr@hc-sc.gc.ca.