Role

Medical Device Vigilance Lead

Device Vigilance Leads manage post-market surveillance distinct from medicinal product pharmacovigilance yet increasingly interconnected. Monitor FDA device recalls, field safety notices, MDR vigilance obligations, and drug–device combination updates requiring coordinated safety assessment across PV and quality teams.

1 update · Sorted by impact priority

publicTga · Australia · Updated May 24, 2026

Australia: TGA refreshes device post-market monitoring hub and responsibilities

Monitoring

1) Add/confirm the TGA 'medical device post-market monitoring and safety updates' page as a tracked regulatory intelligence source for routine review. 2) Cross-check internal Australia device vigilance SOPs/work instructions against TGA guidance on sponsor/manufacturer post-market responsibilities and document any gaps for CAPA/change control as needed.

Signal ValidationLocal Affiliate ComplianceLocal Safety Officer

SOP Impact5 SOPs

ConfidenceMedium

Relevant for: Local Safety Officer, Signal Management Lead, Regulatory Intelligence Lead

verifiedRegulatory action: Devices

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