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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Oct 4, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has published a guidance document dedicated to software for use with COVID-19 rapid antigen self-tests. Apart from other aspects, the document describes...
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Sep 28, 2021
Uncategorized
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the regulatory requirements to be applied in the case of software intended to be used with rapid...
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Aug 18, 2021
Europe
The UK Medicines & Healthcare products Regulatory Agency (MHRA), the country’s regulating authority in the sphere of medicinal products and medical devices, has published a guidance document dedicated to the equipment for temperature screening intended to be used...
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Jun 24, 2020
Australia and Oceania
In relation to difficulties associated with the Coronavirus or COVID-19, The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, issued a notice dedicated to the delay in the implementation of certain...
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