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Regulation & Re-classification of Software based Medical Devices - TGA Australia

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.

This guidance is intended to provide information on the regulation that applies to software and apps which meet the legislated definition of a medical device in Australia.

The purpose of this guidance’s is to help manufacturers and sponsors understand how the TGA interprets requirements, and thus indicate how manufacturers and sponsors can comply.

The documents are currently in draft and updates and clarifications will be included as required.

All new applications for the inclusion of software-based medical devices in the Australian Register of Therapeutic Goods (ARTG) must meet these new classification rules.

The Re-classification of software-based medical devices guidances provides information about the new classification rules for software-based medical devices that (PDF):

  • provide a diagnosis or screen 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

  • provide therapy through the provision of information

The transition arrangements for devices that may need to be reclassified end on 25 August 2021.

Watch this video on how to access the transition period for software-based medical devices.


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