Feb 2, 2023
Australia and Oceania
The article provides an overview of the new classification rules for certain medical devices recently introduced in Australia. Table Of Contents: The guidance is intended to provide medical device manufacturers and other parties involved in manufacturing medical...
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Nov 19, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to software-based medical devices. In particular, the document provides examples of software products that...
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Oct 4, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has published a guidance document dedicated to software for use with COVID-19 rapid antigen self-tests. Apart from other aspects, the document describes...
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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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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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