May 21, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published guidance on reclassification of medical devices that administer medicines or biologicals by inhalation. The document falls within the...
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May 20, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian authority responsible for regulations in the sphere of healthcare products, has published guidance dedicated to auditing medical device applications. The scope of the document covers not only general medical...
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May 17, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian authority responsible for medical device regulation, has published detailed guidance describing the documentation to be submitted by the applicant in the context of inclusion of a medical device to the...
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Apr 28, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has published detailed guidelines dedicated to clinical decision support software (CDSS). The document describes general regulatory requirements,...
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Apr 21, 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 revised guidelines on clinical evidence for medical devices. The document is intended to provide medical...
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