Health Canada proposes amendments to the Food and Drug Regulations and Medical Devices Regulations to modernize framework for therapeutic product recalls

On April 15, 2023, Health Canada proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations (together, the “Proposed Amendments”). The Proposed Amendments are intended to modernize the frameworks for establishment licences and recalls of therapeutic products (i.e., drugs and medical devices) (see our previous article on Health Canada’s notice of consultation and notice of intent).

In particular, and further to amendments to the Food and Drugs Act introduced through the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law; previously reported in updates in 2014 and 2018), the Proposed Amendments would introduce a reporting framework for therapeutic product recalls ordered by the Minister of Health. This includes requirements for information to be reported to the Minister and timeframes for doing so.

The Proposed Amendments would also:

1. address reporting requirements for voluntary recalls of therapeutic products (with exemptions for low-risk medical devices);
2. introduce record-keeping requirements for recalls of medical devices (both voluntary and when ordered by the Minister);
3. update the list of designated regulatory authorities in the Food and Drug Regulations by referring to an ambulatory list that would include all regulatory authorities within countries that have a mutual recognition agreement with Canada;
4. conditionally exempt packagers, labellers, distributors and importers of radiopharmaceuticals or gene or cell therapies from finished product testing requirements under the Food and Drug Regulations;
5. update requirements for medical device establishment licence applicants and holders to submit contact information to the Minister; and
6. grant the Minister authority to impose (or amend) terms and conditions on a medical device establishment licence.

Health Canada’s consultation on the Proposed Amendments is open until June 29, 2023.

Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.