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RegulatorsHealth Canada

Health Canada reposts device recall forms and updates GVP GUI-0102

Health Canada lists FRM-0360A/FRM-0360B for device recall reporting and shows GUI-0102 GVP guidance issued/implemented May 22, 2026.

PV Impact Brief

Urgency: HighConfidence: medium
Relevant for
Local Safety OfficerRegulatory Intelligence LeadMedical Device Vigilance LeadPV Quality LeadQPPV
Processes impacted
Local Affiliate ComplianceDevice VigilanceInspection ReadinessRegulatory Intelligence Monitoring
Action needed

Health Canada update requires triage for Local Affiliate Compliance, Device Vigilance, Inspection Readiness; confirm local obligations and document follow-up actions.

Owner

Local Safety Officer

Review cadence

Immediate triage (within 1 business day), then weekly review until closure.

Evidence and confidence

Confidence: mediumSource update date not verified — confirm on the regulator site before acting

Primary-source confirmation recommended before operational implementation.

Full briefing

What changed

Health Canada lists FRM-0360A/FRM-0360B for device recall reporting and shows GUI-0102 GVP guidance issued/implemented May 22, 2026.

Why it matters

Potential impact spans Local Affiliate Compliance, Device Vigilance, Inspection Readiness, Regulatory Intelligence Monitoring, so Local Safety Officer oversight is needed to maintain compliance readiness and evidence traceability.

Practical implication

Health Canada update requires triage for Local Affiliate Compliance, Device Vigilance, Inspection Readiness; confirm local obligations and document follow-up actions.

#Medical Device Vigilance#Country Compliance#Inspection Readiness#Health Canada#Medical Devices#GVP#Device Recall Reporting

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