Jul 30, 2020
COVID-19
The Food and Drug Administration (FDA) has published a new template for emergency at-home and over-the-counter diagnostic COVID-19 tests and medical devices for use in non-lab settings, such as homes, offices, or schools. FDA: Regulatory Background In order to...
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Jul 28, 2020
Australia and Oceania
The Australian Therapeutic Goods Administration (ARTG) and the TGA, an authority responsible for medical device regulations, has updated its guidance on thermometers and other temperature measuring medical devices and products used in the context of Coronavirus...
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Jul 9, 2020
COVID-19
The European Commission (EC), the European body responsible for medical device regulation, published a summary dedicated to the availability and capacity of notified bodies to perform the conformity assessment of medical devices and in vitro diagnostic medical devices...
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Jul 8, 2020
COVID-19
The Medicines and Healthcare products Regulating Authority (MHRA), the UK authority in the sphere responsible for medical devices, issued guidance dedicated to medical devices and personal protective equipment intended to be used in the context of COVID-19....
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Jul 6, 2020
COVID-19
The Food and Drug Administration (FDA) issued updated guidance dedicated to tests intended to be used in the context of the outbreak of COVID-19. Due to the importance of the highlighted issues, the guidance is subject to immediate implementation without public...
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