Sep 21, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a guidance document describing changes to the regulatory framework for software-based medical devices. The document describes the...
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Sep 10, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published an updated guidance document dedicated to personalized medical devices (including 3D-printed devices). The document constitutes a...
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Sep 6, 2021
Uncategorized
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the recent changes in the regulatory framework for software-based medical devices. The new...
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Aug 31, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), Australia’s regulating authority in the sphere of healthcare products, has published a final document describing the refinements to the personalized medical devices framework. The new regulatory approach announced by...
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Jul 26, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has published a user guide on the post-market review compliance dashboard. The document describes in detail how responsible parties can access, review and...
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