The Therapeutic Goods Administration (TGA) Australia has released updates on the regulation of software based medical devices in August 2022.
The guidance was prepared to assist manufacturers and sponsors with the requirements in Australia, and provides additional information such as frequently asked questions, TGA’s regulatory approach, reforms, and others.
There has been an update to the Clinical Decision Support Software (CDSS) section. TGA has provided updates on the exemption of certain clinical decision support software, which can be read in the guidance document “Guidance on the exemption criteria”.
More details can be found in “Regulation of software based medical devices, August 2022”: https://www.tga.gov.au/regulation-software-based-medical-devices