On December 17, 2024, recent amendments to the Food and Drug Regulations (FDR) and the Medical Devices Regulations (MDR) relating to the recall of drugs and medical devices will come into force.

These new requirements establish reporting and other obligations for industry who is recalling (voluntarily or per an order from Health Canada) a drug or medical device. Details about the new requirements are set out below. In summary, they establish timelines within which manufacturers must report recalls to Health Canada, require the submission of a recall strategy and draft customer communications and establish requirements for post-recall reporting and record keeping.

Amendments to Food and Drug Regulations

Reporting Obligations

Voluntary Drug Recalls

Once the amendments to FDR are in force, the recalling firm will be required to notify Health Canada within 24 hours after the decision to recall. This report must be made in writing and is required to contain certain information regarding the product and its distribution, the reason for the recall, its anticipated commencement of the recall, and an assessment of whether there may be disruption in drug supply. Additional information regarding this reporting requirement will be outlined in Health Canada’s Recall policy for health products (POL-00016) and Drug and natural health products recall guide (GUI-0039)

Additionally, within 72 hours of making the decision to recall a drug, the recalling firm will be required to provide Health Canada with a written report detailing the recall strategy and proposed corrective actions .

Mandatory Drug Recalls

In the rare instance of a drug recall ordered by Health Canada, the recalling firm will be required to notify Health Canada in writing within 24 hours of the start and completion of the recall. The amendments to FDR also give Health Canada the authority to compel additional information from the recalling firm, including the recall strategy and description of proposed corrective action.

Communication materials

Prior to notifying customers of a recall, the amendments will require the recalling firm to provide Health Canada with its he proposed recall communication materials for review and also permit Health Canada to request additional communications issued in connection with the recall.

Amendments to the Medical Devices Regulations

Reporting Obligations

Voluntary Medical Device Recalls

Similar to the case with drug recalls, the amendments to the MDR will require the reporting of the recall to Health Canada within 24 hours after the decision to recall. The information required to be submitted includes information about the device being recalled, the reason for the recall and the recalling firm’s preliminary assessment of the risk associated with the recalled product. Additional information will be required to be submitted prior to the recalling firm notifying affected customers of the recall including additional details about the number of affected units of the recalled device, a copy of communications issued in connection with the recall, the proposed recall strategy and corrective actions.

Of note, once the amendments are in force, Type III medical device recalls (a situation in which the recalled device is unlikely to cause any adverse health consequences) will no longer be required to be reported to Health Canada, although recalling firms remain obligated to maintain records in connection with these recalls. This change is intended to bring the Canadian regulatory environment into better alignment with international standards.

The MDR will also require post-recall reporting to Health Canada, as well as the maintenance of records relating to the recall for a 2 year period of time that extends beyond the projected useful life of the recalled device or the cessation of its sale in Canada.

Mandatory Medical Device Recalls

The amendments to the MDR introduce similar notification requirements for a firm recalling a medical device per an order from Health Canada. In addition, in the case of these recalls communications regarding the recall must be provided to Health Canada prior to them being issued.

Next Steps

Health Canada has promised updated guidance (by way of updates to GUI-0039 and GUI-0054) prior to the amendments coming into force in December 2024. Among other things, we await further direction on the meaning of “decision” in the context of a voluntary recall and additional clarity around the timing of the new reporting requirements.

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