Canada Proposes Amendments to Food and Drug Regulations and Medical Devices Regulations to Strengthen Recall Framework and Modernize Industry Reporting Obligations

Canada has proposed amendments to its Food and Drug Regulations (FDR) and Medical Devices Regulations (MDR) to enhance the regulatory framework for recalls of drugs and medical devices, update reporting obligations for industry, and offer conditional exemptions for certain biologics and radiopharmaceuticals. The amendments aim to mitigate risks to health and safety while targeting non-compliance and would bring Canada's regulatory framework up to date with current practices.

The proposed amendments for the MDR would update the definition of recall to include recalls ordered by the Minister, establishing a regulatory framework for recalls of medical devices ordered by the Minister, and clarifying industry's reporting and record-keeping obligations for firm-initiated recalls. Additionally, it would improve international alignment relating to the reporting of low-risk medical device recalls, modernize the Medical Device Establishment Licence (MDEL) application requirements to reflect existing practices, and provide the Minister with the ability to issue terms and conditions on an MDEL to mitigate risks to health and safety, and strategically target non-compliance.

On the other hand, the proposed amendments to the FDR would establish a regulatory framework for recalls of drugs ordered by the Minister, clarifying reporting obligations for industry for voluntary recalls, and updating references to foreign regulatory authorities who participate in mutual recognition agreements (MRA) with Canada. The outdated information would be replaced with an ambulatory list of regulatory authorities incorporated by reference. The proposed amendments would also offer conditional exemptions from requirements related to finished product testing for certain biologics and radiopharmaceuticals, and clarify that direct shipment to a person other than an importer (typically a healthcare provider) is permitted for these products.

Relevant documents:

(*) Notification: G/TBT/N/CAN/694

(*) Canada Gazette, Part I, Volume 157, Number 15: Regulations Amending the Food and Drug Regulations and the Medical Devices Regulations (Recalls, Establishment Licences and Finished Product Testing)