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Australia TGA Post-Market & Vigilance Rules

Australia TGA Post-Market & Vigilance Rules

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In this episode, we break down key compliance obligations, including annual reporting for high-risk devices, adverse event reporting timelines, and Australia’s PRAC process for recalls and market actions. Learn what sponsors and manufacturers must do to stay compliant in the Australian market.

#tgaaustralia #postmarketsurveillance #artg #vigilancereporting #medicaldevice


Note: This episode was created and hosted with AI.

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In the spirit of reconciliation, Audible acknowledges the Traditional Custodians of country throughout Australia and their connections to land, sea and community. We pay our respect to their elders past and present and extend that respect to all Aboriginal and Torres Strait Islander peoples today.