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 30, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to design control. The scope of the document covers such aspects as design input and design output. The...
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Aug 26, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the product lifecycle of infusion pumps. The guidance addresses matters related to the device...
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Aug 20, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority responsible for medical device regulations, has published detailed guidelines describing how one can determine whether software falls within the scope of medical device regulatory...
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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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