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...
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....
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...
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The Therapeutic Goods Administration (TGA) of Australia has published draft guidance on clinical decision support software.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...
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...
