We have published our Clarifying and strengthening the regulation of Medical Device Software including Artificial Intelligence (AI) report. The report provides a detailed overview of the process, outcomes and key findings from the TGA consultation: Clarifying and strengthening the regulation of Artificial Intelligence (AI).
This consultation aimed to identify areas for improvement in the TGA legislative framework to mitigate future risks and leverage opportunities associated with the use of AI within the therapeutic goods sector, including software as a medical device.
You can access a summary of responses to the public consultation on the TGA Consultation Hub.
The Department of Health, Disability and Ageing has also published the final report from their overarching review of the use of AI in healthcare settings on their website: Safe and Responsible Artificial Intelligence in Health Care - Legislation and Regulation Review: Final Report.
Next steps
In January 2025, we received Government approval to undertake further work in response to the 14 key findings of our report.
Additional information related to the review will continue to be published on the TGA website.
