Oct 29, 2021
Asia
Oman’s Directorate of the General Pharmaceutical affair and Drug Control (DGP&DC) has published draft guidance dedicated to medical devices bundling/grouping criteria. The document provides an overview of existing legislation and clarifications regarding the...
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Oct 25, 2021
Asia
The Health Sciences Authority (HSA), Singapore’s regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to IVD analyzers. Among other issues, the document provides additional clarifications...
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Oct 8, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to software intended to be used with in vitro diagnostic medical devices during the outbreak of...
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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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Apr 19, 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 guidance dedicated to in vitro diagnostic (IVD) self-tests intended to be used for diagnosing seasonal...
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