Australia and Oceania The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to software intended to be used with in vitro diagnostic medical devices during the outbreak of...
Australia and Oceania The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has published a guidance document dedicated to software for use with COVID-19 rapid antigen self-tests. Apart from other aspects, the document describes...
Uncategorized The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the regulatory requirements to be applied in the case of software intended to be used with rapid...
Europe The UK Medicines & Healthcare products Regulatory Agency (MHRA), the country’s regulating authority in the sphere of medicinal products and medical devices, has published a guidance document dedicated to the equipment for temperature screening intended to be used...
Australia and Oceania In relation to difficulties associated with the Coronavirus or COVID-19, The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, issued a notice dedicated to the delay in the implementation of certain...
