Mar 16, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to the policy for evaluating the impact of viral mutations on COVID-19 tests....
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Mar 16, 2021
Kazakhstan
The National Center for Expertise of Medicines and Medical Devices (NDDA), Kazakhstan’s body responsible for the assessment of quality and safety of medical devices, has published an official notice dedicated to the updated rules of manufacturing medicines and medical...
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Mar 16, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA) of Australia has published draft guidance on clinical decision support software. The document describes the changes in the regulatory requirements to be implemented in the course of the upcoming improvement of the existing...
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Mar 16, 2021
EU MDR/IVDR
The European Commission (EC), the EU regulating authority in the sphere of medical devices, has published a document describing the regulatory requirements under the MDR EUDAMED framework. Regulatory Background The new guidance published by the European Commission...
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Mar 16, 2021
MHRA
The Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulating authority in the sphere of medical devices, has published a guidance document dedicated to the in-vitro diagnostic (IVD) point-of-care test devices. Aside from other aspects, the...
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