Software is increasingly being used both as a medical device and in medical devices. Some of these devices inform clinical decisions. Others are wearable and provide day-to-day health or wellness-related monitoring and reporting functions. The demand for such devices is rapidly growing.
Unless ‘excluded’ or ‘exempt’, software-based medical devices are required to be included in the Australian Register for Therapeutic Goods (ARTG) prior to supply into Australia and subject to full regulation by the Therapeutic Goods Administration (TGA).
Most software operating in consumer wearable devices with health and fitness functions are likely to be excluded. Clinical decision support system software that meets certain criteria is exempt and does not need to be included in the ARTG, but remains subject to a degree of oversight by the TGA.
Software will come under regulation by the TGA if it meets the definition of a ‘medical device’. This would include any software used either on a standalone basis (ie software as a medical device (SaMD)), or in a device (eg in order to operate that device), that is intended by the supplier to be used for, among other things, the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of a disease, condition, ailment, injury or disability (therapeutic purpose).
Under the Therapeutic Goods (Excluded Goods) Determination 2018 consumer health life-cycle prevention, management and follow up – eg consumer health and wellness products that do not make claims about ‘serious’ diseases or conditions are excluded.
This means that common consumer health and fitness wearables, such as step counters, ‘Fitbits’ and similar devices, as well as diet and wellbeing apps (eg to support better mental health), would be unlikely to be regulated as medical devices in Australia.