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 2, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has published guidance dedicated to certificates of free sale and export certificates. The document describes in detail the eligibility criteria and how...
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May 25, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published guidelines describing the process of inclusion of medical devices in the national register. The present guidelines describe: The process...
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May 25, 2021
Australia and Oceania
The Therapeutic Goods Administration(TGA), the Australian regulating authority in the sphere of medical devices, has published guidance describing specific aspects related to the Declaration of Conformity for certain low-risk medical devices. In particular, the scope...
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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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