Health Canada’s recall shake-up: navigating mandatory orders and reporting requirements for medical devices

New and clarified requirements for recalls under the Food and Drug Regulations and Medical Devices Regulations (MDR) are in force as of December 14, 2024. Many of these revisions will be familiar as they formalize existing expectations on reporting medical device recalls previously outlined in Health Canada's guidance. We highlight the key regulatory changes introduced by the latest amendments below.

What are the changes?

• Mandatory recalls: the definition of "recall" is broadened in the MDR to include corrective action ordered by Health Canada; the term previously referred only to corrective actions voluntarily initiated by manufacturers, distributors, and importers.
• Reporting Timelines: timelines that were previously only expectations are now mandatory for Type I and Type II medical device recalls.
• Exceptions for Type III recalls: Type III (low-risk) recalls no longer need to be reported to Health Canada.
• Communications: any communication material that may be used in starting a mandated recall (e.g., the initial recall notice) must be provided to Health Canada before the recall is initiated.

What is a mandated "recall" under the MDR?

Any action by a regulated party (manufacturer, distributor, or importer) to retrieve or correct a medical device, or notify users of its existing or potential defectiveness, after it has been sold is broadly considered to be a recall. There are three classes of medical device recalls based on the severity and likelihood of adverse health consequences.

• Type I recall: reasonable probability of serious adverse health consequences or death
• Type II recall: temporary adverse health consequences or not a significant probability of serious adverse health consequences
• Type III recall: unlikely to cause any adverse health consequences

A mandated recall occurs when Health Canada determines that a device poses a serious or imminent health risk. While a manufacturer or an importer is encouraged to voluntarily initiate a recall if its product is found to pose a risk to health, a recall order can be used as an enforcement tool to order a person who sells a non-compliant product to recall it from the market. Unlike for voluntary recalls, the person ordered to recall cannot delegate responsibility to another entity for reporting the recall to Health Canada (i.e. a manufacturer may not permit an importer to report on its behalf).

These recalls are assumed to be reserved for the most serious cases or Type I recalls. Interestingly, although Health Canada has had the authority to order recalls for therapeutic products posing serious or imminent health risks since 2014, this power has never been exercised. These recent regulatory changes may signal an increased willingness for Health Canada to enforce such recalls in the future.

Reporting exceptions for Type III risks

Regulated parties initiating voluntary Type III (low-risk) medical device recalls must continue to conduct the recalls and notify end users of any necessary actions. However, they will no longer be required to report these recalls to Health Canada.

These amendments signify a shift in Health Canada's regulatory framework and are intended to align Canada with the standards set by other international jurisdictions. For example, a voluntary Type III recall may involve notifying end users about a labeling update for a device that otherwise remains safe to use and does not need to be removed from the market. Under the previous Canadian framework, such a recall also had to be reported to Health Canada, whereas it did not need to be reported to the regulatory authority in the United States. This inconsistency created administrative and regulatory burden, as well as mislead public perception that the device was unsafe, even though it was unlikely to cause any adverse health consequences.

Health Canada reporting timelines for medical devices recalls

When initiating a Type I or Type II voluntary medical device recall, the recalling company, whether a manufacturer, distributor, or an importer, must follow new timelines. This includes a 24-hour reporting requirement, which was previously only an expectation outlined in guidance. The updated regulatory timeline now includes the following reporting deadlines and required information:

Step 1 - Notification to Health Canada

Within 24 hours of making the recall decision:

• Device information (including its name, identifier, licence number, and authorization number);
• Contact information for the manufacturer and importer;
• Reason for the recall;
• Nature of the defectiveness, including the date and circumstances of its discovery;
• Initial evaluation of the risk associated with the defectiveness.

Step 2 - Initial Recall Report

On or before the day of the recall:

• Information from Step 1 (Notification to Health Canada);
• Contact information for the representative of manufacturer or importer;
• Quantity of affected units;
• Name of persons who were sold an affected unit;
• Copies of communications issued about the recall;
• Recall strategy, including start and end dates;
• Proposed actions to prevent a recurrence.

Step 3 - Final Recall Report

Within 30 days of completing the recall:

• Results of the recall;
• Actions taken to prevent a recurrence.

In addition to the above, recalls ordered by Health Canada come with extra reporting obligations. The person ordered by Health Canada to conduct the recall must also:

• submit proposed communications to Health Canada before initiating the recall to allow Health Canada to evaluate whether the communications adequately address the identified risk; and
• notify Health Canada within 24 hours of both the start and completion of the recall.

Recordkeeping requirements

Manufacturers, distributors, and importers must continue to keep records that demonstrate they have completed an effective and timely recall - including for Type III (low-risk) recalls. These records must include the reason for the recall, actions taken to recall the device, and any outcomes.

Importers and distributors will be required to keep recall records for at least the projected useful life of the device plus two years. Manufacturers will be required to keep recall records for at least as long as the device is being sold or the projected useful life of the device plus two years, whichever is longer. The recordkeeping timeline for manufacturers differs from other regulated parties in the supply chain because most issues that require a recall originate at the manufacturers' level.

Health Canada has announced updates to its guidance documents to reflect the new reporting requirements.

The authors would like to thank Brandon Pierre, articling student, for his contribution to preparing this legal update.