Apr 28, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has published detailed guidelines dedicated to clinical decision support software (CDSS). The document describes general regulatory requirements,...
Read More
Apr 21, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices and other healthcare products, has published revised guidelines on clinical evidence for medical devices. The document is intended to provide medical...
Read More
Apr 19, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices and other healthcare products, has published guidance dedicated to in vitro diagnostic (IVD) self-tests intended to be used for diagnosing seasonal...
Read More
Apr 13, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA or the Agency), the Australian regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to the use of market authorization evidence from comparable...
Read More
Apr 8, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of medical devices and other healthcare products, has published a checklist intended to assist medical device manufacturers and other parties involved in conducting a...
Read More