You are here Home How we regulate Manufacturing Manufacture a medical device Manufacture specific types of medical devices Artificial Intelligence (AI) and medical device software How the TGA regulates software based medical devices Information about our regulatory approach for software based medical devices. Last updated 24 February 2021 Listen Print Share Loading... Supporting documents How the TGA regulates software based medical devices [PDF, 763.63 KB] How the TGA regulates software based medical devices [Word, 8.29 MB] Topics Medical devices safety Regulatory compliance Therapeutic goods regulation Main navigation