Software-based medical devices are medical devices that incorporate software or are software, including software as a medical device (SaMD), 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, unless otherwise excluded. The TGA has implemented reforms to the regulation of software-based medical devices, which have come into effect from 25 February 2021. Some software might be excluded from the Therapeutic Goods Medical Devices Regulations 2002, or although still regulated by TGA, may yet be exempted from the need to include the product in the ARTG (Australian Register of Therapeutic Goods).
Let’s now take a look on the software that is regulated under the TGA regulations.
The guidance provides information about the new classification rules for software based medical devices that:
- • Provide a diagnosis or screens for a disease or condition
- • Monitor the state or progression of a disease or condition, or the parameters of a person with a disease or condition
- • Specify or recommend a treatment or intervention
- • Provides therapy through the provision of information.
If your software is to be used by a general consumer (or their carer) to manage an existing disease or condition, but it is not used by a health professional and/or clinical practice, then it is considered to be 'intended for self-management'. If the general consumer shares information generated by your software with a health professional and/or a clinical practice but neither of them uses it for diagnosis or treatment (instead, just for information), then the software is also considered to be 'intended for self-management'. In both above cases, the software may be excluded from the TGA regulations as long as it is for a disease or condition that is not serious. However, if a health professional and/or clinical practice does use the information for any diagnosis or treatment, the software is no longer 'intended for self-management'. In that case, the software is not excluded and it does come under the TGA regulations.
TGA regulates software-based medical devices that are being supplied or distributed in Australia, so therefore, for the software which is cloud-based on a server outside Australia, it does not matter where the server is based, where your website is hosted or if the data is stored in the cloud and/or in a different country.
For a more detailed evaluation of your product, please feel free to contact us directly for more information.
Software-based medical devices FAQs
Regulation of software based medical devices