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.