Mar 19, 2021
EU MDR/IVDR
The United Kingdom has adopted a final version of a regulatory framework for medical devices to be in force after Brexit. The new legislation prescribes the approaches to be applied with regard to the regulatory procedures associated with placing medical devices on...
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Mar 19, 2021
Russia
Roszdravnadzor, the Russian regulating authority in the sphere of medical devices, has published the updated rules for evaluation of the software intended to be used for medical purposes. The document initially issued on February 12, 2021, and named “The...
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Mar 19, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published the updated guidelines on the risk management approach to be applied with regard to medicines and medical devices. The document provides...
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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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