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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Dec 9, 2021
Australia and Oceania
The second article provides an in-depth review of the TGA application form and describes the way the submitter should provide information about the applicant entity and the medical device(s) subject to review. The Therapeutic Goods Administration (TGA), an Australian...
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Dec 2, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to applying for consent to import, supply, or export a medical device that does not comply with the...
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Oct 26, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the classification of active medical devices (including software-based ones). The document issued in...
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