You are here Home Product regulation Medical devices Software and artificial intelligence Manufacturing for software and artificial intelligence 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 LinkedIn (Twitter) Facebook Email Loading... Supporting documents How the TGA regulates software based medical devices [PDF, 779.22 KB] How the TGA regulates software based medical devices [Word, 8.29 MB] Product types Software and artificial intelligence Topics Compliance and enforcement Main navigation