Dec 2, 2020
FDA
The Food and Drug Administration (FDA) has published an enforcement policy for bioburden reduction systems using dry heat to support single-user reuse of certain filtering facepiece respirators during the outbreak of COVID-19 and public health emergency associated...
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Dec 2, 2020
Canada
Health Canada has published a guidance dedicated to the applications for medical devices under the Interim Order for use in relation to the COVID-19. Interim Order (IO) constitutes a special document issued to accelerate the implementation of vitally important rules...
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Nov 2, 2020
FDA
The Food and Drug Administration (FDA), the US regulating authority, has published a revised enforcement policy for non-invasive remote monitoring devices used to support patient monitoring during COVID-19. Notes The present document actually constitutes a new...
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Nov 2, 2020
Saudi Arabia
The Saudi Food and Drug Authority (SFDA) of Saudi Arabia has published a guidance dedicated to the requirements for medical masks and particulate respirators – the medicinal products that become vitally important in the context of the COVID-19. The document also...
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Oct 22, 2020
MHRA
The Medicines & Healthcare products Regulatory Agency (MHRA), the UK regulating authority in the sphere of medical devices, has published the Target product profile (TPP) for the tests intended for the point of care use to detect the virus SARS-CoV-2 (the “novel...
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