Drugs and medical devices (ICS codes: 11.120, 11.040)

Regulations Amending the Food and Drug Regulations and the Medical Devices Regulations (Recalls, Establishment Licences and Finished Product Testing), (63 pages, available in English and French)

The proposed amendments to the Food and Drug Regulations (FDR) would:

· Establish a regulatory framework for recalls of drugs ordered by the Minister. Clarify reporting obligations for industry for voluntary (firm initiated) recalls.

· Update the outdated references to foreign regulatory authorities who participate in mutual recognition agreements (MRA) with Canada and replace the outdated information with an ambulatory list of regulatory authorities incorporated by reference.

· Offer conditional exemptions from requirements related to finished product testing for certain biologics (e.g., gene and cell therapies) and radiopharmaceuticals, as well as clarify that direct shipment to a person other than an importer (typically a healthcare provider) is permitted for these products.

The proposed amendments for the Medical Devices Regulations (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 the industry's reporting and record keeping obligations for firm-initiated recalls;

· 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 a MDEL to mitigate risks to health and safety, and strategically target non-compliance.