Feb 2, 2023
Malaysia
The new article highlights the aspects related to the scope of information and documentation the authority expects to be included in requests from interested parties. Table Of Contents: The Medical Device Authority (MDA), a Malaysian regulating authority, has...
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Jun 9, 2022
Australia and Oceania
The article provides an overview of the current regulatory framework for the re-registration of medical devices in Malaysia and describes in detail the most important aspects to be considered when submitting a respective application. The Medical Device Authority...
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Sep 10, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published an updated guidance document dedicated to personalized medical devices (including 3D-printed devices). The document constitutes a...
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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 29, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has published a consultation paper dedicated to proposed changes to the regulatory requirements for personalized medical devices. Apart from the general...
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