Mandatory Problem Reporting — Timeframes
Overview
The clock for mandatory problem reporting starts when any person in your organisation becomes aware of information suggesting a reportable event has occurred. It is not limited to when the regulatory affairs team becomes aware.
Timeframes
| Event type | Deadline |
|---|---|
| Death or serious deterioration — unexpected (not described in IFU as known risk) | 10 calendar days from awareness |
| Death or serious deterioration — expected (described in IFU as known risk) | 30 calendar days from awareness |
| Device malfunction/deterioration that could cause or contribute to death or serious deterioration if it recurred | 30 calendar days from awareness |
What triggers the clock
The reporting clock is triggered when anyone in the company (including field sales staff, clinical application specialists, customer service, or management) receives information suggesting a reportable event. Internal escalation processes must ensure this information reaches the regulatory affairs team promptly.
Initial vs. follow-up reports
- Initial report — submitted within the required timeframe, even if the investigation is incomplete
- Follow-up reports — submitted as investigation findings become available, including root cause analysis, CAPA, and outcomes
Health Canada expects initial reports to be submitted on time even when investigation is ongoing. The initial report should include all information available at the time.
Reporting from other jurisdictions
If a device is subject to mandatory reporting in another jurisdiction (e.g., an FDA MDR or EU Serious Incident Report), Health Canada does not automatically receive that report. A separate MPR must be submitted to Health Canada if the criteria are met for Canadian reporting.
Practical internal process
Recommended internal process:
- Customer service or field staff receive complaint → immediately flag to regulatory/safety team
- Regulatory/safety team assess for reportability within 24–48 hours
- If reportable → prepare and file MPR within required timeframe
- Commence investigation → submit follow-up reports as findings develop
Legislative source: Medical Devices Regulations, SOR/98-282, ss 59–64