New Recall Requirements for Drugs and Medical Devices

By Kevin Bushell and Scott Foster

Amendments to the Food and Drug Regulations and the Medical Devices Regulations will require new reporting obligations for recalls of drugs and medical devices. These amendments come into force on December 17, 2024.

The legislation was enacted to address concerns that the Food and Drug Regulations and the Medical Devices Regulations did not have a sufficient reporting framework for therapeutic product recalls ordered by the Government of Canada.

Food and Drug Regulations

The amendments will require manufacturers and importers of drugs who decide to voluntarily recall a drug to report the decision to Health Canada within 24 hours of the decision.  The report must include:

• information about the affected lot and the distribution of the drug;
• an assessment of the risk of injury to human health posed by the drug;
• expected start and completion dates of the recall; and
• the date and the manner on which the situation that prompted the recall was discovered.

The recalling party must also provide a strategy for the recall within 72 hours of making the decision.

For recalls ordered by Health Canada, the amendments will allow Health Canada to compel information it believes necessary to mitigate the risk of injury to human health.

For all recalls, the recalling party must provide to Health Canada within 30 days the results of the recall and a description of measures to prevent a recurrence of the cause of the recall.

Medical Devices Regulations

For voluntary recalls of medical devices, the recalling party will be required to make a report to Health Canada within 24 hours of its decision to recall including:

• the nature of the defect or potential defect affecting the devices and the circumstances in which it was discovered; and
• a preliminary evaluation of the risk of the defect or potential defect.

On or before the day the recall begins, recalling parties will also be required to provide further information relating to the distribution of the device and the proposed strategy for the recall.

For ordered recalls of medical devices, recalling parties must provide similar information along with any other information that Health Canada believes is necessary to reduce the risk of injury to health.

For all medical device recalls, the recalling party must within 30 days provide to Health Canada the results of the recall and a description or measures to prevent a recurrence of the cause of the recall.

Amendments to the Medical Devices Regulations will also impose record keeping requirements on recalling parties.