Canada: Medical Device Incident Reporting

Welcome back to MedTech Compliance Chronicles! This week we are turning our attention to one of the most important responsibilities manufacturers face after their devices reach the Canadian market: incident reporting. Reporting the occurrence of certain events that occur during the use of a medical device is a legal obligation under the Canadian Medical Devices Regulations (CMDR). By requiring manufacturers and importers to notify Health Canada of serious device-related problems, the system ensures that risks are detected quickly and corrective action can be taken before additional harm occurs.

In the world of medical devices, ensuring patient safety does not end with a product’s market authorization. Once a device is in use, manufacturers and importers have a critical responsibility to monitor its performance and report any incidents that could lead to unreasonable harm. This is one of the most, if not the most, critical aspects of any robust post-market surveillance system. It enables the identification of potential issues, the implementation of corrective actions, and the prevention of future harm to patients and users. A thorough understanding of these requirements is a fundamental aspect of a company’s commitment to product safety and public health. In this post, we will break down the regulatory foundation of incident reporting, explain what qualifies as a reportable event, and walk through the reporting process step by step.

What is a Reportable Incident?

Incident reporting in Canada is grounded in the CMDR, Sections 59 through 61.1. These provisions establish that manufacturers and importers carry the legal responsibility to notify Health Canada when a device problem meets the definition of a reportable incident. The requirement applies to all classes of licensed devices marketed in Canada, regardless of risk level. 

A reportable incident is defined as any device-related event that has resulted in the death or serious deterioration of the health of a patient, user, or other person. Just as importantly, incidents that could result in such outcomes if they were to recur must also be reported. This second category ensures that potential risks are addressed proactively, not only after harm has occurred. Quick note here, if a reportable incident happens in another country with a device that is also licensed in Canada, you must report the incident ONLY IF you take some sort of corrective action (recall, FSCA, etc.) in response to the incident. 

To understand this more clearly, consider a few examples. A malfunction that causes a device to stop performing as intended may be reportable if it poses a realistic risk of death or serious injury, think an AED not delivering adequate voltage or a life support machine powering off unexpectedly. A labeling error that provides incorrect dosage instructions could also meet the threshold if the dosage displayed could pose risk of death or serious deterioration in health. In this latter case, suppose two physicians both have this incorrectly labeled device, one physician notices the discrepancy and gives a dosage they know to be adequate based on their medical training, whereas another physician just follows the dosage on the labeling exactly. Assuming the labeled dosage is enough to cause unreasonable harm, both incidents would be reportable. The first because it could result in unreasonable harm if the physician had not noticed the discrepancy and taken action to preclude that harm from occurring, and the second because the harm was actually realized. 

When organizations receive a complaint or report, they are required to diligently investigate and collect enough information to determine whether a reporting threshold is met. Health Canada expects manufacturers and importers to actively consult with health professionals, gather supporting data, and retrieve affected products as needed for assessment. The system is designed to prioritize safety by erring on the side of caution, encouraging reporting when in doubt as to whether the incident is reportable or not.

The Reporting Process

The process for reporting medical device incidents in Canada is structured to ensure timely and thorough communication between manufacturers, importers, and Health Canada. When any complaint is received, a natural instinct for all medical device manufacturers should be to determine whether the incident meets mandatory reporting criteria in all jurisdictions in which that device is sold. In Canada, organizations must follow a two-stage reporting requirement, consisting of a preliminary report followed by a final report.

The preliminary report is the report that Health Canada’s reporting timelines refer to. The CMDR outlines two reporting timelines, depending on the severity of the incident. If the event resulted in death or a serious deterioration in health, it must be reported within 10 calendar days of the manufacturer or importer becoming aware of it. If the event did not cause such an outcome but could reasonably lead to it if repeated, the report must be filed within 30 calendar days. The countdown begins as soon as the company has enough information to recognize the event as reportable, not when the investigation is complete.

Reports are submitted by emailing, faxing or mailing Health Canada’s Mandatory Problem Reporting Form for medical devices to the addresses listed on Health Canada’s website. This form requires specific details, including the device name and identifier, the manufacturer or importer’s information, a description of the incident, the consequences to the patient or user, and any preliminary assessment or corrective measures taken. If further details emerge after the initial submission, follow-up reports are expected to ensure the regulator has a complete picture of the risk. When the investigation is complete, a final report must be submitted. In cases where the initial complaint contains all information required to complete the investigation and the full investigation is finished prior to the initial reporting timeline, manufacturers may submit a single report with all required information from both the preliminary and final reports. 

Health Canada places significant weight on the timeliness and completeness of incident reports. Late submissions or incomplete information not only raise compliance concerns regarding the device, but may also signal weaknesses in a company’s quality system.

Conclusion

Effective incident reporting is an essential element of any medical device regulatory framework, helping to ensure prompt action is taken when device-related safety concerns arise. By understanding the regulatory foundation and following the defined reporting process, manufacturers and importers can fulfill their legal responsibilities and contribute to a safer healthcare environment.