Asia The Health Sciences Authority (HSA), Singapore’s agency responsible for regulations in the sphere of healthcare products, has published a guidance document dedicated to the medical device unique device identification (UDI) system. Table of Contents Apart from the...
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 unique device identification system. In particular, the document is...
Asia The Health Sciences Authority (HSA), Singapore`s regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to the medical device unique device identification (UDI) system. The latest version of the...
EU MDR/IVDR Today marks a landmark event for medical device manufacturers around the globe: the date of full implementation of the EU’s MDR. Starting today all new medical device registrations that fall within the scope of the European Medical Device Regulation (MDR) must be...
Australia and Oceania The Therapeutic Goods Administration (TGA), the medical device regulating authority, has published a final consultation paper dedicated to the Australian Unique Device Identification (UDI) System to be implemented in the country in the course of the ongoing...
