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 Is my software regulated? Flowcharts showing which software products are regulated as a medical device, and those that are not. Last updated 27 July 2021 Listen Print Share Loading... Supporting documents Is my software regulated? [PDF, 84.94 KB] Topics Medical devices safety Safety Therapeutic goods regulation Main navigation