Update: On April 15, 2023, Health Canada proposed amendments to the Medical Devices Regulations and the Food and Drug Regulations.
On January 7, 2022, Health Canada issued a notice of consultation for proposed amendments to the Medical Devices Regulations.
The notice of consultation (i) advises of the notice of intent published on December 11, 2021 and (ii) requests feedback on a cost-benefit analysis survey. The proposed amendments would (1) streamline Medical Device Establishment Licence (MDEL) holders application requirements to reflect existing practices; (2) provide the Minister with new and expanded authorities over MDELs, including the ability to issue terms and conditions on a MDEL and partially suspend or cancel a MDEL to mitigate risks to health and safety; and (3) implement ministerial authority to order recalls of medical devices, harmonize the definition of recall and clarify industry reporting obligations in guidance.
The notice of intent is open for comment until February 11, 2022.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.
The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.
Related Publications & Articles
-
Health Canada releases its Statistical Report 2024/2025 for PMNOC Regulations, data protection and CSPs
On July 25, 2025, the Office of Patented Medicines and Liaison of Health Canada released its Statistical Report 2024/2025 for the Patented Medicines (Notice of Compliance) Regulations, Data Protection...Read More -
Health Canada aims to reduce red tape by increasing international collaboration, alignment and reliance
In July 2025, the Government of Canada launched a “Red Tape Review” across all federal departments to modernize regulatory frameworks and support economic growth.Read More -
Medical devices updates: new Health Canada guidance for determining medical device application type and Medical Devices Directorate performance reports released
In August 2025, Health Canada released the Guidance for determining medical device application type.Read More