On 16 October 2026, the Therapeutic Goods Administration (TGA) published the outcomes of its review of digital scribes, the AI tools that record or listen to consultations and draft clinical notes. The headline finding: of 12 scribe products the TGA reviewed, 8 included functions likely to meet the definition of a medical device, even though none of their suppliers had identified them as one.
If your practice uses, or is considering, an AI scribe, this matters. This article explains what the TGA found, what makes a scribe a medical device, and what dentists and practice owners should check now.
This article is general information based on the TGA's published review and guidance and on news reporting. It isn't legal or regulatory advice.
Key takeaways
- The TGA identified around 100 Australian digital scribe suppliers, surveyed them and reviewed 12 products in detail.
- 8 of 12 had functions likely to make them medical devices, 2 needed more information, and 2 appeared unlikely to qualify.
- None of the 12 suppliers had identified their product as a medical device.
- The TGA isn't naming products, but says it will use the findings for guidance, education and targeted compliance activity.
- A scribe that only records, transcribes or summarises what was said is generally administrative. One that suggests diagnoses or treatments, triages, or draws patient-specific clinical conclusions may be a medical device that must be in the ARTG.
What the TGA reviewed
The TGA identified about 100 digital scribe suppliers in Australia, received survey responses from about 40, and reviewed 12 products, a mix of larger and smaller tools. The products were selected, so the results aren't an estimate for the whole market. The review looked at whether products' functions and claims met the medical device definition. It didn't test safety or accuracy, check detailed compliance, or assess privacy.
When is a scribe a medical device?
The TGA decides based on a product's intended purpose, judged from its functions, design, instructions, advertising and how it's presented, not just the supplier's disclaimers.
Generally not a medical device:
- Recording the consultation
- Transcribing speech to text
- Translating
- Summarising what was said, without adding clinical content
May be a medical device:
- Analysing patient information to suggest diagnoses or differential diagnoses
- Recommending treatment the clinician didn't state
- Triaging or monitoring patients
- Producing patient-specific clinical conclusions
A product's status can change with a software update that adds new features, so a tool that was fine last year may not be today.
The clinical decision support exemption
Some clinical decision support software is exempt from ARTG inclusion, but the exemption is narrow. Broadly, the software must be intended only to provide recommendations to a health professional, must not replace their judgement, must not analyse data from another medical device, and must show how its recommendation was reached. Exempt software is still a regulated medical device. The TGA has also amended the exemption's wording, with changes reported to take effect from 1 November 2026, so check the current version.
What this means for dental practices
Dental-specific scribes are newer than medical ones, but the same rules apply. If your scribe:
- only drafts notes from what was said, it's likely to be administrative software, though your professional and privacy obligations still apply
- adds clinical suggestions, such as possible diagnoses, recommended treatment or risk assessments, it may be a medical device that should be in the ARTG
Using an unapproved medical device can create risks for your practice, so it's worth checking.
What to do now
- List the AI tools your clinicians use for notes, including any free or trial tools.
- Check what each one does. Does it ever add diagnoses, treatment suggestions or clinical conclusions that the dentist didn't say?
- Ask your vendor in writing whether they consider the product a medical device, and if so, for its ARTG entry.
- Turn off clinical suggestion features you don't need, if the product allows it.
- Watch for updates. Ask vendors to tell you when new features could change the product's status.
- Keep reviewing every note. Whatever the regulatory status, the dentist is responsible for the clinical record.
For the full picture on consent, privacy and Ahpra obligations, read our guide to AI scribes for dentists.
Frequently asked questions
Which scribe products did the TGA flag?
The TGA hasn't published product-specific findings. Ask your vendor directly about their product's regulatory status.
Is it illegal to use an AI scribe?
No. Many scribes are administrative tools. The question is whether a particular product's functions make it a medical device that should be in the ARTG.
Does the review mean scribes are unsafe?
The review didn't assess safety or accuracy. It looked at regulatory status. Practices should still check accuracy and review every note.
Next steps
Ask each AI scribe vendor you use for a written statement on their product's TGA status this week. For more on AI in clinical practice, see our guide to AI in dentistry and AI dental X-ray analysis. IntelliDent's AI works at the front desk, answering calls and booking appointments, not making clinical decisions. See how it works.