Take one piece of clinical decision support software: it reads a patient's record and suggests a next step to a doctor. In the United States it may not be a medical device at all. In the European Union it is almost certainly a device that needs a notified body. In Australia, from 1 November 2026, it can stay off the Australian Register of Therapeutic Goods (ARTG) only if it passes five tests instead of three. If you supply software in Australia under the exemption today, you have until 31 October to check it against the new tests.
This post covers what the amendment says, which software it moves onto the register, and how the same product is treated in four other markets. That comparison matters most for a startup planning which market to enter first.
What changed
The Therapeutic Goods Legislation Amendment (2026 Measures No. 1) Regulations 2026 (F2026L01167) were made on 3 September and registered on 7 September 2026. Part 3 of Schedule 1 commences on 1 November 2026. Item 48 replaces the description of exempt clinical decision support system (CDSS) software in Schedule 4, Part 2, item 2.15 of the Therapeutic Goods (Medical Devices) Regulations 2002.
| Until 31 October 2026: exempt if the software is… | From 1 November 2026: exempt only if the software… |
|---|---|
| (a) for the sole purpose of providing or supporting a recommendation to a health professional about preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury | (a) is intended to make a recommendation to a health professional for the sole purpose of assisting them in making a decision related to preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury |
| (b) not intended to directly process or analyse a medical image or signal from another medical device | (b) is not intended to process, analyse, compress or decompress a medical image or signal from another medical device (the word "directly" is gone) |
| (c) not intended to replace the clinical judgement of a health professional in making a clinical diagnosis or treatment decision | (c) unchanged |
| — | (d) new: is not intended to make a clinical diagnosis or treatment decision, including where the software is in vitro diagnostic software |
| — | (e) new: displays the clinical practice guidelines, calculations or logic it uses, so that a health professional can readily interpret and verify any recommendation while using it |
The new tests also apply to software already on the market. New regulation 11.90 (item 49) applies the amended exemption to devices manufactured on or after 1 November, and to devices manufactured before then that are intended to be used after it. We found no grace period for CDSS in the instrument or its Explanatory Statement. The same instrument gives a five-year transition to an unrelated reclassification of saline flush syringes, so a transition was possible and was not given here.
Why TGA calls it a clarification
The Explanatory Statement says the new item "seeks to clarify that some products will not meet CDSS exemption criteria, and remove perceived ambiguity". TGA consulted on it in 2024, and most respondents supported it. That framing makes sense once you read TGA's own guidance. Its CDSS guidance page (last updated 29 January 2026, as it stood on 25 September 2026) already said that to meet criterion (c) the software must be transparent and "cannot use proprietary analysis or AI to generate recommendations". It also said "an AI-enabled CDSS will not meet the exemption criteria" and "opaque CDSS do not meet exemption criterion (c) and are not exempt."
So for most developers the policy is not new; the law is catching up with the guidance. Some companies read the shorter 2021 wording more generously than TGA did and launched on that reading. From 1 November, that reading is no longer available in the regulation itself.
"Exempt" never meant unregulated
Many founders miss this. Exempt CDSS is still a medical device, and item 2.15 carries conditions that the amendment does not touch:
- the device must comply with the essential principles, and the manufacturer must apply the appropriate conformity assessment procedures and be able to show it on request;
- adverse events must be reported within the regulation's deadlines (48 hours for a serious threat to public health, down to 60 days for other information);
- the sponsor must notify TGA of each import or supply. The regulation says within 20 working days, or a longer period the Secretary agrees to; TGA's guidance page says 30 working days.
If you have been supplying in Australia under the exemption and never notified TGA, fix that first. It is a condition of the exemption you are relying on today.
Which software now needs ARTG inclusion
From 1 November, CDSS falls outside the exemption, and must be on the ARTG before it is supplied unless another exemption applies, if any of these is true:
- It does not show its working. Under condition (e), the clinician must be able to see the guideline, calculation or logic behind each recommendation while using the software. A risk score with no visible derivation fails. So, on TGA's stated reading, does a machine-learning model whose output cannot be traced to stated logic.
- It makes the call itself. Condition (d) covers software intended to make a diagnosis or treatment decision, including IVD software. In TGA's guidance, a module that returns "diabetes mellitus" from lab values is not exempt, even though the endocrinologist reviews it.
- It touches images or device signals in any way. Without "directly", and with "compress or decompress" added, condition (b) covers more of the processing chain than before. That includes signals from IVDs, which TGA's guidance already counted.
- It monitors or alerts. TGA's guidance treats threshold-based monitoring alerts as not exempt. Its example is a sepsis tool that flags patients and proposes antibiotics without stepping through its logic.
- It is for patients. This is unchanged. The exemption covers only recommendations to a health professional, so consumer-facing decision support never qualified.
Before you assess any of this, check whether the software is a medical device at all, and whether it is excluded under the Therapeutic Goods (Excluded Goods) Determination 2018. TGA's guidance treats both as outside its regulation entirely, which is a different position from being exempt.
Where it lands if it fails
Australia classifies software by rules, not by a list. The software rules in Schedule 2 of the Medical Devices Regulations treat software that informs a health professional's diagnosis or treatment decision more lightly than software that makes the decision:
- Software that gives information to a health professional for a diagnosis, or recommends a treatment to a health professional, is Class I, IIa or IIb, depending on how serious the condition is or how harmful a wrong treatment could be (clauses 4.5(2) and 4.7(2)).
- Software that itself provides a diagnosis or specifies a treatment is Class IIa to III (clauses 4.5(1) and 4.7(1)).
For much decision support that fails only condition (e), the likely result is Class I or IIa. Class I uses the manufacturer's own declaration of conformity, with no assessment by TGA (regulation 3.9). Class IIa and above need conformity assessment evidence: a TGA certificate or, through Australia's comparable-overseas-regulator route, evidence from authorities such as the EU, the US or Canada. TGA's guidance sets out which overseas evidence counts for which class, so check it for your device.
How the same software is treated elsewhere
| Market | Qualifying decision support is… | The tests that decide it | If it does not qualify |
|---|---|---|---|
| Australia (from 1 Nov 2026) | A medical device that is exempt from the ARTG, with conditions attached | Five conditions (above). Health professionals only. On TGA's reading, AI-enabled CDSS does not qualify | ARTG inclusion, Class I to III under the software rules |
| United States | Not a device, so there is nothing to file | Four statutory criteria (FD&C Act s 520(o)(1)(E)): no images, IVD signals or signal patterns; health professionals only; the professional can independently review the basis. AI/ML is not disqualifying in itself, because FDA's guidance asks the labelling to describe the approach. Time-critical uses fail. FDA's January 2026 guidance says it does not intend to enforce where only one recommendation is clinically appropriate | A device under FDA's normal software policies |
| European Union | No equivalent carve-out. Software with a medical purpose is a device, and general-purpose software is not | Intended purpose (MDR Art 2(1), recital 19); then Rule 11 | Rule 11: software whose information is used for diagnostic or therapeutic decisions is Class IIa at least (IIb or III by impact), so a notified body is involved |
| Canada | Not a device if all four criteria are met | Four criteria close to the US ones, but the users may include patients and caregivers. Software that drives immediate or near-term action generally does not fit. Health Canada calls them "a foundation for an analysis", not rigid rules | A device, classified under the Medical Devices Regulations |
| Great Britain | No exemption. Decision support that applies automated reasoning is "usually considered a medical device" | MHRA guidance: reference-only tools, where the clinician makes the decision, may not be devices | UK MDR 2002 rules: often Class I (self-declared, registered with MHRA); software that allows direct diagnosis is Class IIa |
Sources, read on 19 October 2026: F2026L01167 and its Explanatory Statement; Therapeutic Goods (Medical Devices) Regulations 2002, Compilation No. 72; TGA, Understanding clinical decision support system software regulation (archived copy of 25 September 2026); US FD&C Act s 520(o)(1)(E) as quoted in FDA, Clinical Decision Support Software (final guidance, 29 January 2026); Regulation (EU) 2017/745, Annex VIII Rule 11; Health Canada, Software as a Medical Device (SaMD): Definition and Classification (2019); MHRA, Medical device stand-alone software including apps v1.10g. We did not read the EU's MDCG 2019-11 software guidance or Health Canada's separate examples document for this piece.
Two things in this table matter for planning.
A US exclusion gives you nothing to rely on in Australia. Software that is non-device CDS in the US has no FDA clearance, so it has no FDA approval to put forward as comparable overseas evidence if it lands in Class IIa or above in Australia. An EU certificate is a different case. Rule 11 puts most decision support at Class IIa or above, so a company that holds an MDR certificate for the product has the kind of evidence Australia's overseas-regulator route was built for. Here, the market that regulates the product more heavily is the one whose approval travels.
Transparency is the common ground. Australia's new condition (e), the US "independently review the basis" criterion, Canada's fourth criterion and the MHRA's point about whether the clinician reviews the raw data all ask the same question: can the clinician check the software's reasoning? If you design for that once, the software can qualify for the lighter treatment in four of these five markets. Without it, the software is a regulated device in all five.
What to do before 1 November
- List every product you supply in Australia without an ARTG entry, and confirm that each one was notified to TGA.
- Test each one against conditions (a) to (e) as they will read on 1 November, starting with (e) and (d). Test the product as a clinician sees it: the screen, the instructions for use and your marketing claims, because intended purpose is read from all three.
- For anything that fails, make one of three decisions and write it down. You can change the product (show the logic, or remove the output that amounts to a diagnosis or decision). You can narrow its claims. Or you can plan ARTG inclusion and decide what happens to supply in the meantime. We found no grace period. If you believe one applies to you, get TGA's view in writing rather than assuming it.
- Check who your sponsor is. The ARTG entry is held by the Australian sponsor, not the manufacturer. If your distributor sponsors it, that distributor holds your market access. When you are moving onto the register anyway, decide deliberately whether to use your own entity, an independent sponsor or the distributor.
After 1 November
For a product that has to be on the register, the class decides the timeline. Class I is a declaration plus an ARTG application through your sponsor. Class IIa and above depend on conformity assessment evidence, which is where the choice of first market comes in. Australia was a cheap first market for a decision-support startup while the exemption was broad. If your product now needs Class IIa evidence, the EU certificate you may have been leaving until later could be what unlocks Australia, and a US non-device position will not help.
Australia's register shows who has moved. As at 19 October 2026, our Australian corpus holds 1,119 active ARTG entries for standalone software, 309 of them Class I, and 273 of the 1,119 were included on or after 1 January 2025. The products this amendment affects are, by definition, not on the register, so no database can count them today. New inclusions that follow the change will appear on the register, and we will be watching for them.
The short version
- From 1 November 2026, exempt CDSS in Australia must also show its logic and must not make the diagnosis or treatment decision itself. Processing, compressing or decompressing an image or device signal now rules it out.
- The change applies to software already supplied. We found no grace period.
- TGA's guidance already said AI-enabled and opaque CDSS were not exempt. The regulation now says much the same.
- Exempt was never unregulated: essential principles, adverse-event reporting and notification to TGA still apply.
- US non-device status gives you nothing to rely on in Australia. An EU certificate can.
- Design the software so a clinician can verify its reasoning. That is the condition that keeps decision support in the lighter category across most of these markets.
This is our reading of the instruments listed above, written for planning. It is not regulatory advice for a specific product. Check your classification and any transitional position with TGA or your sponsor before acting.