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...
Africa 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 on the rules prescribing the collection of samples to be...
Africa The Tanzania Medicines & Medical Devices Authority (TMDA), the country’s regulating authority responsible for healthcare products, has published a draft regulation on good storage and distribution practices with regard to medicines and medical devices. Regulatory...
Russia An order of the Minister of Healthcare of the Russian Federation has been published. The order implements the administrative regulation the Roszdravnadzor shall follow when issuing establishment licenses to the entities engaged in manufacturing and maintenance of...
