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Re-classification of software based medical devices

12 August 2021

Recent changes to regulation of software based medical devices came into effect in early 2021, which result in change of classification level for certain devices.

All new applications for inclusion of software based medical devices in the Australian Register of Therapeutic Goods (ARTG) must meet these new classification rules. For software that is already on the ARTG, there is a transition period.

To access the transition period, you need to notify the TGA before 25 August 2021.

How the changes for software based medical devices may affect you

The guidance below provides information about the new classification rules for software based medical devices that:

  • 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.

Watch the video below for an overview on how to access the transition period for software based medical devices.

What you need to do

Read the guidance to check if your software based medical device has been impacted by the changed classification rules and ensure that you can continue to supply your device legally in Australia.

Regulatory changes for software based medical devices

This guidance provides a summary of changes to the regulation of software based medical devices (including software as a medical device)

Fill in the notification form, 'Transition arrangements for software-based medical devices', and submit to the TGA before 25 August 2021.

Notification form

Contact us

If you would like to contact us, please email digitaldevices@health.gov.au or call 1800 141 144