Software-based medical devices are medical devices that incorporate software or are software, including software as a medical device, or software that relies on particular hardware to function as intended, and are regulated in Australia by the Therapeutic Goods Administration (TGA). Software (including mobile apps) is a medical device if it fits within the definition of a medical device in section 41BD of the Therapeutic Goods Act 1989- external site, unless otherwise excluded.
Many mobile apps are simply sources of information, or tools to manage a healthy lifestyle. The TGA does not regulate health and lifestyle apps or other software that does not meet the definition of a medical device.
For guidance on the regulation of medical device software and apps go to:
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.