Kazakhstan
The National Center for Expertise of Medicines and Medical Devices (NDDA), Kazakhstan’s agency responsible for the assessment of quality and safety of medical devices, has published an official notice describing the updated rules on a temporary suspension of...
Australia and Oceania
The Malaysian Medical Device Authority (MDA), Malaysia’s agency responsible for regulations in the sphere of healthcare products, has published draft guidance dedicated to the general medical device grouping. The document was published on the official website and made...
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has published detailed guidance dedicated to personalized medical devices. The document provides additional clarifications and recommendations regarding...
FDA
The Food and Drug Administration (FDA), the US regulating authority in the sphere of medical devices and healthcare products has published an action plan on Software as a Medical Device (SaMD) based on the Artificial Intelligence / Machine Learning (AI/ML)...
MHRA
The Medicines & Healthcare products Regulatory Agency (MHRA), the UK regulating authority in the sphere of medical devices, has published detailed guidance dedicated to the off-label use of medical devices. The scope of the guidance covers only the medical devices...
Australia and Oceania
The Therapeutic Goods Administration (TGA) of Australia has published detailed guidelines dedicated to the regulation of Personal Protective Equipment (PPE) in the context of the outbreak of COVID-19. These devices are facing a significant increase in demand during...
