Australia has remade the exemption for clinical decision support software so that from 1 November 2026 the software would have to display the guidelines, calculations or logic behind a recommendation to stay outside medical device inclusion

What the substituted item 2.15 would say

Item 2.15 of Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 describes a kind of medical device that is exempt, subject to conditions, from the requirement to be included in the Australian Register of Therapeutic Goods. Item 48 of Schedule 1 Part 3 repeals the cell that describes the kinds of device covered and substitutes a new one. That substitution takes effect on 1 November 2026.

From that date the exempt kind would be clinical decision support system software that satisfies five limbs together. Paragraph (a) requires that the software 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 related to preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons.

From 1 November 2026, paragraphs (b) to (d) would operate as exclusions. The software would not be intended by its manufacturer to process, analyse, compress or decompress a medical image or signal from another medical device; would not be intended to replace the clinical judgement of a health professional in relation to making a clinical diagnosis or decision about the treatment of patients; and would not be intended to make a clinical diagnosis or decision about the treatment of patients, including where the software is in vitro diagnostic software.

Paragraph (e) is the one that changes product design. It requires that the software "displays details of the clinical practice guidelines, calculations or logic used by the software, in a way that enables a health professional to readily interpret and verify any recommendations while using the software in a clinical context intended by the manufacturer". Once the amendment commences, a tool that fails that limb would fall outside item 2.15 and would no longer be exempt on that basis.

Which limbs are new, on the explanatory statement's own account

The instrument repeals and substitutes a whole cell, so its text alone does not tell a reader which words are new. The explanatory statement registered with it does, and we take the following from that document rather than from the regulations.

The explanatory statement says the substitution seeks to clarify that some products will not meet the exemption criteria and to remove perceived ambiguity, and it lists three changes: in paragraph (b), removing the reference to directly and adding compress and decompress alongside the existing process and analyse; introducing new paragraph (d) on diagnosis and treatment decisions including in vitro diagnostic software; and introducing new paragraph (e) on displaying guidelines, calculations or logic.

It also records the consultation history. The Therapeutic Goods Administration says it consulted in 2024 on the proposed amendment to the criteria for exempt clinical decision support software in item 2.15, and that the proposal received majority support from respondents. That is the department's own account of its own consultation, and we report it as such.

The explanatory statement describes paragraph (e) as clarifying. Whether a display requirement that did not previously appear in the cell is a clarification or a new condition is a characterisation, and it is the department's characterisation rather than ours.

Which devices the new item would catch, and when

Item 49 inserts regulation 11.90, an application provision, and it is wider than a straight prospective rule. From 1 November 2026 the amended item 2.15 would apply to a medical device manufactured on or after that commencement, and also to a medical device manufactured before that commencement that is intended by its manufacturer to be used on or after it.

That second limb matters for anything already deployed. A tool built and shipped in 2025 that a manufacturer intends to be used into 2027 would be assessed against the new five-limb item from 1 November 2026, not against the item as it stood when the software was written.

The instrument contains no transitional grace period for that limb and no grandfathering clause attached to item 2.15. Other parts of the same regulations do carry time-limited arrangements, including a five-year run-off for transitional kinds of device under the unrelated saline classification change at regulation 11.88, which makes the absence of an equivalent provision here worth noticing.

We do not state what follows for a product that falls outside the exemption. The consequence sits in the Therapeutic Goods Act 1989 and the inclusion requirements of the Register, and we did not open either.

Why the AI reading is ours and not the instrument's

Nothing in F2026L01167 mentions artificial intelligence, machine learning, algorithms or models. The instrument is drafted in the technology-neutral language of intended purpose, and paragraph (e) would apply identically to a hand-coded scoring rule and to a neural network.

The reason it lands hardest on statistical models is ours to argue. Paragraph (e) would ask for details of the guidelines, calculations or logic used, displayed so that a clinician can readily interpret and verify a recommendation while using the software. A rules engine satisfies that by showing the rule it fired. A model that outputs a score with no exposed derivation would need design work if its supplier wants to rely on the amended exemption, and retrofitting an interpretable display onto a trained model is a product decision with a lead time.

Note the standard the limb sets, because it is not full transparency. It asks for interpretation and verification by a health professional in the clinical context the manufacturer intends, which is a usability test rather than an engineering disclosure. That reading is ours; the words the instrument uses are readily interpret and verify.

For product teams outside Australia the transferable question is the same one. If a clinician using your tool were asked why it recommended what it recommended, would the answer come from your interface or from your documentation. From 1 November 2026 in Australia, that difference would decide whether the exemption is available.

What we did not verify

What we opened: the regulations as made, fetched live from the Federal Register of Legislation this session and read in full, including the commencement table, item 48 and the application provision at item 49; and the explanatory statement registered with the instrument, which we read for its account of item 48 and its consultation record. The register page header shows F2026L01167 and 07 September 2026, and the making block on the face of the instrument reads Dated 3 September 2026.

What we did not open: the Therapeutic Goods (Medical Devices) Regulations 2002 as currently in force, so we did not read the repealed version of the item 2.15 cell ourselves. Our account of which paragraphs are new rests on the explanatory statement and is attributed to it throughout. We also did not open the Therapeutic Goods Act 1989, the conditions column of item 2.15, the 2024 consultation papers or any Therapeutic Goods Administration guidance on software-based medical devices.

What we refuse to claim: we do not say any manufacturer is now required to display its logic, because Schedule 1 Part 3 commences on 1 November 2026 and until then the amended item does not operate. We do not say the amendment regulates artificial intelligence, because the instrument does not use the term; the reading connecting paragraph (e) to opaque models is ours and is marked as such. We do not state what regulatory consequence follows for a product that leaves the exemption, because that sits in instruments we did not read. We do not describe the change as a tightening or a loosening relative to the old cell, because we did not read the old cell.

We also do not repeat the conditions in column 3 of item 2.15, which the instrument leaves untouched and which we did not examine. The exemption is conditional, and this piece addresses only the kinds-of-device limb.

Informational analysis for working professionals, not legal advice. Confirm how any rule applies to your situation with qualified counsel.

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