Medical devices reforms: software regulation

The AI review

We have reviewed our legislation for software, including AI, to determine if the rules are still appropriate and how they could be improved. This work was part of an overarching review into AI in healthcare by the Department of Health, Disability and Ageing.

We engaged with over 600 stakeholders, resulting in 14 findings. The review confirmed that the TGA's regulation of software and AI remains broadly appropriate. It also identified opportunities for further action and improvement. The findings are grouped into 5 priority areas:

1. Support stakeholders
2. Robust regulation
3. Reinforce roles and responsibilities
4. Improve transparency of AI use
5. Conduct compliance activities

To address these findings, we are:

• Improving information about software and AI on our website
• Reviewing key areas and definitions in our regulations
• Making it easier to see when a product is AI-enabled and complies with TGA regulations
• Undertaking targeted compliance activities

TGA AI review report

Departmental report

Improving information

To support stakeholders find the information they need, we've reviewed and refreshed our online content about software and AI. This was based on stakeholder feedback and usability testing.

We have rewritten over 30 webpages to make content clearer and easier to find.

We're also delivering software-based medical device webinars and free regulatory coaching sessions together with ANDHealth. For upcoming dates and how to book visit ANDHealth.

Review of the exclusion for some digital mental health tools (DMHTs)

A subset of DMHTs are currently excluded from TGA regulation (see Understanding the digital mental health tool software conditional exclusion). The AI review found that this exclusion may no longer be appropriate and should be reviewed.

This review is being informed by surveys of users (like consumers and health professionals) and of software developers, together with market research on health software.

We've also been meeting with an expert advisory group representing the digital health and mental health sectors.

Public consultation on regulatory options is planned for 2026.

Improving transparency

In response to stakeholders requesting more transparency about AI use in medical devices, we published a list of AI-enabled medical devices in the Australian Register of Therapeutic Goods (ARTG).

We are also reviewing the Therapeutic Goods Advertising Code to make sure it's clear, up to date, and supports safe product use.

In 2026, we consulted on software-specific proposals, including:

• Displaying the ARTG number in advertisements for software-based medical devices
• Introducing software-specific mandatory statements
• Requiring relevant health warnings
• Adding disclosure requirements for AI that is a medical device

For more details, visit Improvements to the Therapeutic Goods Advertising Code.

Compliance activities

Digital scribes review

We have been reviewing digital scribes (also known as ambient scribes or AI scribes) available in Australia to:

• identify products in supply and their functionalities; and
• clarify when they meet the definition of a medical device.

The outcomes of the review will be published shortly.

For more information on when and how we regulate digital scribes, see Digital scribes.

Past projects

In 2021, the Essential Principles for medical devices were amended to clarify existing requirements for software-based products.

Regulations were also introduced to classify software-based medical devices according to their potential to cause harm by providing incorrect information.

At the same time, certain low-risk software-based medical devices were carved-out (excluded) from TGA regulation. We also reduced the regulatory obligations for clinical decision support system software that meet certain criteria. This was intended to ensure sponsors and manufacturers of software-based products are not subject to unnecessary regulatory oversight.

Consultations and surveys