Health Canada MPR + Foreign Risk Notification SOP — SOR/98-282 §59 & §61.2

Process Package — Vigilance Reporting Canada

Canada has TWO distinct reporting paths and both are audited. (1) MPR — Mandatory Problem Report under SOR/98-282 §59 with 10-day or 30-day timelines for events in Canada; (2) FRN — Foreign Risk Notification under §61.2 requiring 72-hour notification when a foreign regulator/manufacturer has taken corrective action abroad on the same/similar device sold in Canada. Both paths can apply to the same event.

What’s included:

• SOP-VIG-CA Vigilance Reporting Canada — full procedure: MPR reportability per §59 (two cumulative criteria), FRN requirement under §61.2 with the 72-hour clock starting from manufacturer awareness, Type I recall 24-hour notification, recall procedure per GUI-0054, MDSAP audit considerations.
• F-VIG-CA.1 Canadian MPR + Foreign Risk Notification Worksheet (Word) — combined worksheet with Path A MPR assessment (two cumulative criteria), Path B FRN assessment (foreign action triggers), timeline calculators for both paths, recall classification, and peer review.

Why this package: The 72-hour FRN deadline and Type I recall 24-hour notification are the strictest timelines in any MDSAP jurisdiction. This package gives you a single worksheet that captures both paths so events don’t slip through the cracks.

Format: Microsoft Word
Updated: May 2026 — includes SOR/2024-136 recall amendments
Delivery: Instant download after purchase