Software-based medical devices

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.

Key information

For guidance on the regulation of medical device software and apps go to:

• Regulation of software-based medical devices
• Software-based medical devices FAQs