Sep 28, 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 regulatory requirements to be applied in the case of software intended to be used with rapid...
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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 16, 2021
Australia and Oceania
Australia’s Therapeutic Goods Administration (TGA) has published updated guidance dedicated to personalized medical devices. Apart from other aspects, the document addresses the regulatory matters related to the medical device production systems (MDPS). Table of...
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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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Aug 27, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published guidance on regulatory changes for software-based medical devices. The present document constitutes an updated version of guidance...
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