TGA steps up oversight of AI and software-based medical devices

TGA steps up oversight of AI and software-based medical devices

29 Aug 2025

The regulator is working with industry to encourage voluntary compliance, provide clear guidance, respond to complaints, and take action against unlawful advertising or supply.

One area under review is AI-powered “digital scribes”. Some of these programs now include advanced functions, such as suggesting diagnoses or treatments, which could mean they are classed as medical devices under the Therapeutic Goods Act 1989. If so, they must be listed on the Australian Register of Therapeutic Goods (ARTG) before being supplied or advertised, unless specifically exempt.

The TGA said it will act on cases of non-compliance in line with its regulatory framework and has encouraged the public to report any concerns about software products being sold or promoted outside the rules.

Source: Therapeutic Goods Administration

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