Rapid innovation in technology has driven significant changes to software function and adoption, giving rise to a larger number of devices able to inform, drive or replace clinical decisions, or directly provide therapy to an individual. Advances in computing technology and software production have led to a large increase in the number of software-based medical devices available on the market, requiring the implementation of reforms to ensure patient safety.
Software based medical devices are medical devices that incorporate 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 the definition of a medical device in section 41BD of the Therapeutic Goods Act 1989, unless otherwise excluded.
TGA has updated on 24 May 2021, their regulatory position for data collection components used by Software as a Medical Device (SaMD) in smart devices, tablets, laptops and similar digital hardware.
For SaMD that use data collection components integrated into consumer smart devices:
- – Where the data collection components (such as sensors) are integrated into a smart device, the smart device is a finished consumer product (e.g. smart phones, tablets and laptops). In this circumstance, the smart device is not required to be included in the Australian Register of Therapeutic Goods (ARTG).
- –In order to demonstrate compliance with the essential principles, it is a requirement that the SaMD is validated against the data collection component(s) and/or smart device. The data collection components or smart device must also be validated for the intended use of the SaMD to ensure it is safe and fit for purpose.
- –It should be expected that the level of scrutiny applied to such data collection component(s) would be commensurate with the level of risk associated with the intended use. For example, a Class III SaMD which provides a diagnosis of a lifethreatening disease or condition should expect a high level of scrutiny applied to the validation of any sensors used to perform its intended use, such as a camera.
In summary, SaMD is required to be included in the ARTG for supply in Australia, with evidence of validation against the data collection component(s), using applicable state of the art testing; the data collection component(s) themselves are not required to be included in the ARTG if integrated into a finished consumer smart device.