Regardless of whether your medical device is registered in Canada or in the United States, there are specific reporting requirements for any incidents or adverse events involving your device.
Canada
Manufacturers and importers of medical devices are required to file a preliminary and final report for incidents involving their devices.
Upon notification of the incident, manufacturers and importers must:
- Submit a preliminary report to Health Canada, outlining the details of the incident and any applicable corrective actions required.
- Notify consumers of the corrective action.
- Submit a final report to Health Canada with an investigation of the incident and the results of all corrective actions taken.
- Document all reports and correspondence with Health Canada.
Adverse Reaction Reporting Services for Canada
- Adverse reaction evaluation and classification
- Guidance on how, when, and where to submit serious adverse reaction reports
- Preparation of adverse reaction case reports
- Preparation of adverse reaction annual summary reports for Health Canada and the Marketed Health Products Directorate (MHPD)
- Record maintenance for serious and non-serious adverse reactions
- Procedure creation for Call Center Representatives on handling calls completing AER forms
- Training for Call Center Representatives on handling calls and completing AER forms
- Creation of templates for Customer Complaints
United States
Manufacturers, importers, and device user facilities of medical devices are considered mandatory reporters and must submit medical device reports (MDR) of medical device problems to the FDA. Also known as post-market reporting, the FDA has outlined specific requirements for MDRs in regulation 21 CFR Part 803
You must report an adverse event to the FDA if:
- Your medical device has caused or contributed to death or serious injury
- Your medical devices malfunctioned and could potentially have caused death, or serious injury
Adverse Event Reporting (AER) Services for the United States:
- Adverse event evaluation and classification
- Guidance on how, when, and where to submit FDA Form 3500 and 3500A
- Preparation of adverse event case reports
- Record maintenance for serious and non-serious adverse events
- Procedure creation for Call Center Representatives on handling calls completing AER forms
- Training for Call Center Representatives on handling calls and completing AER forms
- Creation of templates for Customer Complaints
Contact our medical device specialists using the form below for support with medical device reporting