Aug 24, 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 medical device patient information leaflets. The document outlines the scope of information the...
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Jul 20, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority responsible for medical devices, has published detailed guidelines dedicated to the process of inclusion of a new medical device in the Australian Register of Therapeutic Goods (ARTG), the...
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Jul 13, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices and other healthcare products, has published an official information notice dedicated to custom-made medical devices. The notice is intended to provide...
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Jun 10, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a consultation paper dedicated to the proposed refinements to the regulation of personalized medical devices. Table of Contents...
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Jun 7, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published an official notice on conformity assessment bodies. According to the notice, starting July 1, 2021, entities based in Australia may apply...
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