The TGA's CDSS Rules Change on 1 November: The Five-Limb Test for GP Clinics

From Sunday 1 November 2026, clinical decision support system (CDSS) software can only stay off the Australian Register of Therapeutic Goods (ARTG) under the CDSS exemption if it meets five limbs — all five, together. One of them is new in practice: the software must display the guidelines, calculations or logic behind its recommendations so a health professional can readily interpret and verify them while using it. The test also reaches software made before 1 November and still in use after it — nothing grandfathers out. Here is what the test says, what it means for tools your practice already runs, and the questions worth putting to vendors this week.

What changes on 1 November?

The exemption that lets some lower-risk CDSS software be supplied without ARTG inclusion gets a clearer, stricter definition. The Therapeutic Goods Legislation Amendment (2026 Measures No. 1) Regulations 2026 (F2026L01167, registered 7 September 2026) substitutes the CDSS exemption item in Schedule 4 of the Medical Devices Regulations with a five-part test, effective 1 November 2026 (Schedule 1, Part 3).

Two things stay the same, and both matter for how you read this. First, the TGA frames the amendments as clarification, not expansion: they "do not change the scope of the CDSS exemption or introduce new regulatory requirements" (TGA news, 8 September 2026). Second, exemption from ARTG inclusion is not exemption from regulation — exempt software remains subject to the conditions attached to the exemption, including the essential principles.

What are the five limbs?

Under the amended item, exempt CDSS software is a medical device that:

1. Solely assists a decision. It is intended by its manufacturer to make a recommendation to a health professional for the sole purpose of assisting that professional in making a decision about preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury.
2. Does not process images or signals. It is not intended to process, analyse, compress or decompress a medical image or signal from another medical device.
3. Does not replace clinical judgement. It is not intended to replace the clinical judgement of a health professional in making a clinical diagnosis or treatment decision.
4. Does not make the decision itself. It is not intended to make a clinical diagnosis or treatment decision — including in vitro diagnostic software.
5. Shows its logic. It displays the clinical practice guidelines, calculations or logic it used, in a way that lets a health professional readily interpret and verify any recommendations while using the software in its intended clinical context.

The limbs are cumulative: fail one, and the exemption is not available. A device that falls out of the exemption is not automatically unlawful — but it must take another regulatory pathway, generally ARTG inclusion, before it is supplied.

Does the test apply to software we already use?

Yes. Regulation 11.90, inserted by the same amendment, applies the new test to a medical device manufactured on or after 1 November 2026 and to a device manufactured before that date if the manufacturer intends it to be used on or after that date. There is no transition period for existing software: if a tool was built before 1 November and is still intended for use afterwards, it is assessed against the five limbs like anything else. For a clinic, that means the CDSS and AI-assisted tools already running in your consulting rooms are in scope from Sunday — the vendor's job to assess, but your patients' data inside the tool.

What does "displays the guidelines, calculations or logic" mean in practice?

Limb (e) is the one with the most practical bite. It requires the basis of a recommendation to be visible to the clinician at the point of use — the words are "readily interpret and verify... while using the software". A reference to a guideline buried in a policy PDF, a user manual, or a marketing document does not display anything while the clinician is using the tool. What meets the limb looks like: the guideline source, the calculation, or the decision logic shown alongside the output, so the clinician can check the reasoning without leaving their workflow.

The TGA has already shown why this matters beyond CDSS. Its digital scribe review, published on 16 October 2026, found eight of twelve scribe products included functions likely making them medical devices — and not one supplier had identified its own product that way. The TGA's line on vendor labels deserves quoting in full context: "statements or disclaimers are not sufficient in determining if a product is, or is not, a medical device". Function is what counts, and the place to inspect function is the product itself. (Our guide to safe AI in general practice covers the scribe review in detail.)

What should our clinic ask vendors this week?

Seven questions, in order of usefulness:

1. Which of the five limbs does your product meet — and where is the documented assessment? Ask for the assessment against the amended wording that starts 1 November, not the pre-amendment criteria, with a date and a named role behind it.
2. Can you show me limb (e) in the product? On a screen, in the workflow — where are the guidelines, calculations or logic displayed while the recommendation is on screen?
3. Does anything in the product process, analyse, compress or decompress images or signals from another medical device — including pre-processing that happens before a recommendation is displayed?
4. Is any output intended to make a diagnosis or treatment decision, rather than solely to assist a health professional's own decision?
5. If your product stops qualifying for the exemption from 1 November, what is your plan for existing customers — ARTG inclusion, a functional change, or withdrawal — and by when?
6. What shipped in your last update, and what is on the roadmap? Software that gains functions with a therapeutic use changes category — the scope-creep problem the TGA has named publicly. This question is worth re-asking at every update.
7. Who in your organisation owns the regulatory assessment, and how will you notify customers if the answer changes?

Record the answers in the practice's AI-tool inventory — tool, vendor, what it does, assessment date, next check date. If a vendor cannot answer the first two questions, treat that as the answer.

Where Docsert AI sits on this

Our own design answer, stated as design. Docsert AI structures documents from data the clinician supplies — templates plus the clinician's own content. It does not generate clinical content, and it does not diagnose, interpret or recommend; the clinician reviews, edits and approves every output before it goes anywhere. We describe how it is built and let you judge it against the five limbs and the seven questions above — we make no regulatory claim about it either way. If that sounds like the kind of tool you want in the practice, try the interactive demo at docsert.jsaenz.au.

One more line for the accreditation file

AI governance is now an explicit expectation under the RACGP Standards' 6th edition, and AGPAL's published webinar takeaways (8 September 2026) recommend starting with an inventory of the AI tools a practice already runs — the same inventory the questions above feed. It sits alongside the other standing inventories an accredited practice keeps, like vaccine cold-chain logs; our free Accreditation Readiness Checklist gathers the governance domains in one place.

This page is a factual summary, not legal advice. Whether any specific product qualifies for the CDSS exemption is a question for its manufacturer — and for your medical defence organisation if the answer is unclear. Legislation and regulator pages change — confirm against the current instrument and TGA guidance before acting.