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
-
CIPO expected to resume patent granting on August 20
According to CIPO’s updated roadmap, patent granting should resume on August 20, 2024.Read More -
Release of Statistical Report 2023/2024 for PMNOC Regulations, data protection and CSPs
On August 12, 2024, the Office of Patented Medicines and Liaison of Health Canada released its Statistical Report 2023/2024 for the Patented Medicines (Notice of Compliance) Regulations, Data Protecti...Read More -
Health Canada releases notice on aligned reviews between Health Canada and health technology assessment organizations
On November 5, 2024, Health Canada released the Notice to industry: Aligned reviews between Health Canada and health technology assessment organizations.Read More