On June 17, 2024, the Canadian government published SOR/2024-136, amending the Food and Drug Regulations (FDR) and Medical Devices Regulations (MDR). These amendments aim to improve the oversight of therapeutic products, including drugs and medical devices, with a specific focus on recalls, establishment licensing, and finished product testing. This initiative responds to the rapid pace of innovation and the evolving landscape of public health risks, particularly highlighted by experiences from the COVID-19 pandemic.

The amendments address several critical issues within Canada’s regulatory frameworks. They underscore limitations in Health Canada’s ability to manage recalls effectively, as industry stakeholders have expressed concerns about unclear reporting timelines for voluntary recalls that often lead to administrative burdens. Additionally, Canada’s medical device recall requirements are misaligned with those in other jurisdictions, especially concerning low-risk device recalls, which adds to the challenges faced by industry players.

Another significant concern addressed by the amendments is the inadequacy of the existing reporting framework for therapeutic product recalls ordered by the Minister of Health. This lack of clarity can jeopardize Health Canada’s oversight and create potential health risks. The amendments aim to rectify these gaps by introducing clearer obligations for firms conducting recalls, ensuring that Health Canada has the necessary information to manage public health effectively.

The new regulations will implement several important changes. For recalls, manufacturers and importers will be required to report recalls based on risk levels and maintain comprehensive recall records. This aligns Canada with international standards and streamlines the process for firm-initiated recalls.

In terms of establishment licensing, the amendments will facilitate the updating of the list of designated regulatory authorities by utilizing an ambulatory list hosted on the Government of Canada website. This change will ease compliance with Good Manufacturing Practices (GMP), particularly for products sourced from countries that have mutual recognition agreements (MRA) with Canada. Additionally, the amendments will provide conditional exemptions from certain finished product testing requirements for specific radiopharmaceuticals and biologics. These exemptions are designed to reduce regulatory burdens without compromising safety standards, especially for complex products where traditional testing can hinder patient access.

In the area of medical devices, the amendments will modernize the Medical Device Establishment Licensing (MDEL) framework. This modernization will improve flexibility, allowing Health Canada to regulate establishments based on risk more effectively. The updates will also empower the Minister with new authorities to impose terms and conditions on MDELs, thus streamlining the licensing process.

Canada (SOR/2024-136) August 7, 2024