DevicesTgaAustralia
Australia: TGA refreshes device post-market monitoring hub and responsibilities
Relevant for
Local Safety OfficerSignal Management LeadRegulatory Intelligence LeadMedical Device Vigilance Lead+2 more
Action needed
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.
Process impact
Signal ValidationLocal Affiliate ComplianceDevice Vigilance
SOP impact
5 SOPs may need review
Urgency: MonitorConfidence: medium
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