TGA focuses on compliance of AI and software-based medical devices

The Therapeutic Goods Administration (TGA) is stepping up its efforts to make sure that software-based medical devices meet Australia’s regulatory requirements. This includes those using artificial intelligence (AI).

We are already working closely with industry to:

• encourage voluntary compliance
• provide clear and consistent guidance
• respond to complaints and reports of non-compliance
• identify and address unlawful advertising and supply.

Our current focus includes reviewing AI digital scribes, some of which are introducing more advanced features such as diagnostic and treatment suggestions. These features may cause the software to become a medical device under the Therapeutic Goods Act 1989. Such devices must be included in the Australian Register of Therapeutic Goods (ARTG) before being supplied or advertised, unless they are exempt or excluded.

We may take targeted action in response to alleged non-compliance. This is consistent with our regulatory compliance framework.

Report a concern

If you think a software product is being sold or advertised in a way that breaks the rules, you can report it to us.