Written By Ashley Paterson and Julien Sicco

Health Canada is making changes (via legislative amendments) to the manner in which medical devices and pharmaceutical products are recalled under the Medical Device Regulations, SOR/98-282 (MDR) and the Food and Drug Regulations, C.R.C., c. 870 (FDR) respectively. These amendments, which come into force on December 17, 2024, are intended to be responsive to feedback from industry stakeholders and consistent with departmental commitments made by the Ministry of Health. The amendments to the MDR and FDR aim to provide clear recall obligations, increase Health Canada’s supervision over recalls, and better align Canada’s recall procedure with those of other jurisdictions.

Several of the significant legislative amendments are summarized below.

Recall Requirements for Medical Devices under the Medical Device Regulations

Once the amendments come into force, recalls relating to products that are not likely to cause adverse health consequences (i.e. Type III recalls) will not need to be reported, as is presently required. This will align Canada’s recall requirements with those in other jurisdictions and ease the administrative burden on manufacturers and importers.

Further amendments aim to clarify the process for reporting medical device recalls to Health Canada and increase the robustness of this reporting. For example, for recalls initiated by the manufacturer or importer (i.e. voluntary recalls), these amendments clarify:

• the kind of information that needs to be provided to the Minister of Health (the Minister) (for example, the reason for the recall, the nature of the defect, the proposed strategy for the recall, and actions taken to prevent a recurrence of the problem);
• the manner in which that information needs to be provided (typically in writing); and
• the timeframes within which that information needs to be provided (typically within 24 hours of the decision to recall, on the day on which the recall begins, and within 30 days after the recall has been completed).

For recalls initiated by the Minister (i.e. mandatory recalls), the amendments again clarify the kind of information that needs to be provided to the Minister but leave the Minister to determine the time and manner of this communication.

Recall Requirements for Pharmaceutical Products under the Food and Drugs Regulations 

There are comparatively few amendments to the recall procedures under the FDR, but these amendments also seek to clarify the kind of information that needs to be provided to the Minister, the manner in which that information needs to be provided and the timeframes within which that information needs to be provided.

For example, manufacturers and importers initiating a voluntary recall are now required to provide the Minister with specific information (including an assessment of the effect of the recall on the manufacturer or importer’s ability to meet the Canadian drug demand) at various times (including within 72 hours of the decision to make the recall), and manufacturers and importers required to initiate a recall are now required to provide similar information in the time and manner specified by the Minister.

Looking Forward

The amendments to both the MDR and FDR should streamline reporting obligations and bring Canada’s recall framework more in line with other jurisdictions. However, there are still certain outstanding questions relating to these amendments, including when a manufacturer or importer “decides” to initiate a recall and what kind of timelines manufacturers and importers can expect for mandatory recalls initiated by the Minister. Moreover, it remains to be seen whether we can expect further amendments to the MDR or FDR, or to the Food and Drugs Act, R.S.C., 1985, c. F-27 under which these regulations are enacted, in light of the wide-ranging modernization of Canada’s regulatory frameworks for therapeutic products (and, of course, the emergence of AI in this market).

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