The TGA. Australia has provided further information on the reclassification of of software based medical devices.
Recent changes to regulation of software based medical devices
The regulatory changes came into effect on 25 February 2021 as previously reported in this post and this post specifically on clinical decision software. These changes 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.
You can read more about the changes in this guidance document of August 2021 entitled Regulatory changes for software based medical devices.
The transition period
For software that is already on the ARTG, there is a transition period until period ending 1 November 2024.
To access the transition period, you need to notify the TGA before 25 August 2021.
What you need to do to ensure that you can continue to supply your device legally in Australia.
To ensure that you can continue to supply your device legally in Australia, the following steps are necessary:
- If you registered your software based medical device before 25 February 2021, it may have been reclassified. In this case, you will need to re-register it under its new classification. Devices most likely to have been reclassified are those that diagnose, screen, monitor or specify or recommend a treatment
- Read the guidance to check if your software based medical device has been impacted by the changed classification rules.
- If there is an impact, then view the video on this page that the TGA has provided, with an overview on how to access the transition period for software based medical devices.
- Once you have that, you will need to complete and submit the notification form entitled ‘Transition arrangements for software-based medical devices’, and submit to the TGA before 25 August 2021.
Important: If after having read the guidance, you are not sure whether your device has been reclassified, the TGA video recommends that you complete and submit the notification form anyway.
Source: TGA Australia website