You are here Home Guidance and resources Resources Guidance How the TGA regulates software based medical devices Last updated 24 February 2021 Listen Print Share LinkedIn (Twitter) Facebook Email Loading... This guidance summarises the regulatory approach of the Therapeutic Goods Administration (TGA) for software based medical devices.Contents About this guidance TGA regulation of software products Key regulations What to consider Where to find more information Definitions Classification Rules Essential Principles Conformity Assessment Procedures 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]
