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
-
Update on biosimilars in Canada – June 2025
This article provides an update on developments in the biosimilar space in Canada—regulatory, approvals, pending submissions, litigation, and market access.Read More -
Health Canada must redetermine exemption requests for psilocybin (magic mushroom)-assisted psychotherapy training
TheraPsil, a patient advocacy organization, and 73 healthcare practitioners (HCPs) have succeeded in the Federal Court of Appeal to overturn the refusal of the Minister of Mental Health and Addictions...Read More -
2025 mid-year highlights in Canadian life sciences IP and regulatory law
In the first half of 2025, the Rx IP Update team reported on a number of developments in Canadian life sciences IP and regulatory law. Below are our top stories.Read More