In Australia, the Therapeutics Goods Administration (TGA) regulates software-based medical devices (otherwise known as Software as a Medical Device (SaMD)).
According to the 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 unless otherwise excluded.
Software would generally be a medical device if it is intended to be used for:
- diagnosis, prevention, monitoring, prediction, prognosis or
- treatment of a disease, injury or disability
- alleviation of or compensation for an injury or disability
- investigation of the anatomy or of a physiological process
- control or support of conception.
Software considered a medical device, including apps, is regulated by the TGA and must be included in the Australian Register of Therapeutic Goods (ARTG), unless they have been excluded.
A product regulated by the TGA and on the ARTG gives greater reassurance by demonstrating the quality, safety, and performance of the medical device.
Most health apps are simply sources of information, or tools that can help promote healthier lifestyles, and are therefore not regulated by the TGA.
Find more information on the TGA’s Understanding regulation of software-based medical devices webpage.