Why this matters for your practice
Calculators, risk scores, alerts and guideline modules sit inside the clinical software a practice runs, and the TGA says exempt CDSS typically works on data drawn from Electronic Medical Records (EMRs), Electronic Health Records (EHRs) and Clinical Information Systems (CISs). The TGA has said plainly that an AI-enabled CDSS will not meet the exemption criteria.
From 1 November 2026 the exemption test at item 2.15 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 tightens, and regulation 11.90 applies it to software already in use, not only products made after that date. The TGA's position on your role is direct: "As a health professional, you are responsible for the safe and appropriate use of software in your practice." F11 of the RACGP Standards for general practices, 6th edition also names clinical decision support systems as AI tools that may be medical devices under the Therapeutic Goods Act 1989. Our guide to healthcare privacy and cyber security covers the adjacent duties.
What is a clinical decision support system?
A clinical decision support system (CDSS) is software that helps a health professional make a clinical decision. The TGA's working definition, given for the purposes of the exemption, is: "For the purposes of the exemption, a CDSS is software that helps health professionals make decisions about patient care. It may provide prompts, alerts, reminders, or recommendations based on clinical data."
The TGA says CDSS "could be any kind of software": mobile apps, software as a service delivered from the cloud, websites and browser delivered products, as well as traditional software platforms. What the software calls itself does not settle anything. The TGA warns that "Some software may be described as 'clinical decision support', but that is not sufficient to qualify as exempt CDSS." The exemption is for professionals only: "If your software provides decision support directly to patients (or any non-health professional user) it also does not qualify for the exemption."
Is a clinical decision support system a medical device?
Sometimes. It depends on the intended purpose, and the TGA is explicit about who decides: "It is the manufacturer's responsibility to determine if a product is a medical device, based on its intended purpose." Three outcomes follow: not regulated at all, a medical device exempt from ARTG listing, or a medical device that must be on the ARTG before supply.
| Outcome | What it means | TGA example |
|---|---|---|
| Not a medical device, or excluded | Not subject to TGA regulation. The Excluded Goods Determination 2018 sets the exclusions. | A GP Management Plan tool in a CIS that pulls in record data without analysing it. |
| Medical device, exempt under item 2.15 | No ARTG entry needed, but still a medical device. The sponsor must notify the TGA of supply, the software must meet the Essential Principles for safety and performance, adverse events must be reported, advertising rules apply, and the TGA can still act, including by recall or hazard alert. | The McIsaac score calculator; an EMR asthma module based on the Australian Asthma Handbook. |
| Medical device, not exempt | Must be on the ARTG before it can be supplied in Australia, unless another exemption applies. | A diabetes diagnosis module; a sepsis alert tool. |
The AI position is unambiguous. The TGA states that "an AI-enabled CDSS will not meet the exemption criteria." The same goes for tools whose reasoning cannot be inspected: "Opaque CDSS do not meet exemption criterion (c) and are not exempt." An opaque system, sometimes called a "black box", is one that can only be viewed in terms of its inputs and outputs, without any knowledge of its internal workings; a transparent system is sometimes called a "glass box" model.
An AI scribe is a different question. The TGA treats digital scribes on a separate page under its own test: a scribe that "analyses or interprets clinical conversations" by generating a diagnosis, differential diagnosis or treatment recommendation "not explicitly stated by the healthcare practitioner" is a medical device. We cover that test in our AI scribe entry.
How will the CDSS exemption change on 1 November 2026?
Status at 26 September 2026: the new item 2.15 has been made and registered, and it takes effect on 1 November 2026; until then the three-limb version applies.
The change comes from the Therapeutic Goods Legislation Amendment (2026 Measures No. 1) Regulations 2026, register ID F2026L01167, made 3 September 2026 and registered 7 September 2026. Schedule 1, Part 3, item 48 repeals the "Kinds of medical devices" cell at table item 2.15 and substitutes a new one.
| Limb | Until 31 October 2026 | From 1 November 2026 |
|---|---|---|
| (a) | Sole purpose of providing or supporting a recommendation to a health professional. | Reworded: assisting the health professional in making a decision. |
| (b) | Not intended to directly process or analyse a medical image or signal. | "Directly" removed; compress and decompress added. |
| (c) | Not intended to replace the clinical judgement of a health professional. | Unchanged. |
| (d) | No equivalent. | New: not intended to make a clinical diagnosis or treatment decision. |
| (e) | No equivalent. | New: displays the guidelines, calculations or logic used. |
In full: limb (d) requires that the software "is not intended by its manufacturer to make a clinical diagnosis or decision about the treatment of patients, including where the software is in vitro diagnostic software". Limb (e) 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".
Existing software is caught. Item 49 inserts regulation 11.90, which applies the new item 2.15 to a device manufactured on or after 1 November 2026 and to a device that "is manufactured before that commencement and is intended by its manufacturer to be used on or after that commencement". There is no carve-out for software installed before 1 November 2026.
The two official descriptions of this change read differently. The TGA's news item of 8 September 2026 says the amendments "do not change the scope of the CDSS exemption or introduce new regulatory requirements." The explanatory statement to F2026L01167 says the new item 2.15 "seeks to clarify that some products will not meet CDSS exemption criteria, and remove perceived ambiguity for stakeholders." Which one applies to a given product is a question for its vendor. For the full side-by-side wording of every limb and the questions to put to your vendor, see our post on the 1 November 2026 change.
What counts as an exempt CDSS?
The TGA's worked examples below were written against the current three criteria, so treat them as a guide to the regulator's thinking, not a settled list.
The McIsaac score calculator: exempt. A Clinical Information System includes a computerised scoring tool that digitises the McIsaac (Modified Centor score) criteria for assessing tonsillopharyngitis. The GP enters age, fever, cough, exudate and swelling; the software determines the probability score and outputs recommended treatment pathways. "The GP uses their clinical judgement to decide which, if any of the recommended options to follow." The verdict: "This CDSS is exempt." The tool is evidence-based, transparent and independently verifiable.
A guideline module that lists options: exempt. An EMR asthma module based on the Australian Asthma Handbook presents all relevant treatment options, and the clinician selects and signs; a thromboembolism risk assessment tool integrated into an EMR generates a list of prophylaxis options with the same clinician sign-off. Both are exempt because the referenced guideline is published and the clinician, not the software, decides.
A diabetes diagnosis module: not exempt. An endocrinologist enters HbA1c, fasting glucose and glucose tolerance test results into an EMR module, which "returns a diagnosis of diabetes mellitus and recommends a treatment plan"; the endocrinologist reviews and adjusts the plan, but the module is still not exempt. In the TGA's words: "This CDSS is not exempt. It does not meet the exemption criteria because it provides a diagnosis of diabetes mellitus based on the input data."
A sepsis alert tool: not exempt. An evidence-based, proprietary tool monitors clinical parameters and pathology results and recommends a management plan when thresholds are exceeded. It is not exempt because it is for patient monitoring, and "the software does not reference or step through the logic or calculations used to inform the alerts and recommendations." That gap, not referencing or stepping through the logic, is exactly what new limb (e), from 1 November 2026, will require the software to close.
A GPMP tool that only pulls in record data: not a medical device. A GP Management Plan tool inside a CIS auto-populates information from the patient's record, and the GP selects needs and plans. The TGA's verdict: "This CDSS is not a medical device." It "extracts information from the EMR without analysing or summarising the information and there is no therapeutic purpose." But if the tool analyses the information for a medical purpose, such as patient monitoring or diagnostic information, it is a medical device.
One caution: the guidance page was last updated on 29 January 2026 and still sets out three criteria. The TGA has not said whether any example's verdict changes under limbs (d) and (e).
What the regulator or assessor expects
The TGA's page for health professionals tells you to check the software is included in the ARTG, check with the sponsor, understand its intended purpose and use it only for that purpose, document decisions made with software support, and review updates and alerts from the TGA or the sponsor. On problems it is direct: "If the software causes harm or doesn't perform as expected, report it to the Sponsor and follow your organisation's incident management requirements."
You can search the ARTG yourself, and the TGA publishes a list of AI-enabled medical devices in the ARTG.
Criterion F11 of the RACGP Standards for general practices, 6th edition, states that "Some AI tools used in general practice (for example, diagnostic aids, clinical decision support systems, transcription tools) may be classified as medical devices under the Therapeutic Goods Act 1989," and expects practices to confirm ARTG registration, TGA compliance and vendor documentation on regulatory status, seeking legal or regulatory advice if unsure. F11 is not yet assessed: the Australian Commission on Safety and Quality in Health Care (ACSQHC) says "Accreditation under the NGPA Scheme currently uses the 5th edition of the Standards. Information about arrangements for the 6th edition of the Standards will be provided in due course."
One unsettled point: the TGA's duties sit with the manufacturer and the sponsor, and whether a practice using a non-exempt, non-ARTG tool is itself exposed is not settled in any TGA guidance, so that question goes to your medical defence organisation or lawyer. Record each tool's status in your digital health technology governance policy so the position is documented rather than assumed.
Common mistakes
Treating the label as the exemption. A vendor describing a product as "clinical decision support" proves nothing. The TGA says as much: "Some software may be described as 'clinical decision support', but that is not sufficient to qualify as exempt CDSS." The test is the intended purpose and the limbs of item 2.15, not the marketing.
Assuming an AI feature is exempt because the clinician still decides. The TGA's AI line is categorical: "an AI-enabled CDSS will not meet the exemption criteria." The diabetes module example shows why human review does not rescue the position: the endocrinologist reviews and adjusts the treatment plan, and the module is still not exempt because it provides the diagnosis.
Assuming software installed before 1 November 2026 is grandfathered. Not for software relying on the exemption. Regulation 11.90 applies the new item 2.15 to a device "manufactured before that commencement and is intended by its manufacturer to be used on or after that commencement", so it will need to satisfy limbs (d) and (e) like anything else. Software that is not a medical device at all sits outside that test regardless of when it was installed.
Confusing "exempt" with "not regulated". Exempt CDSS is still a medical device, with the sponsor duties set out in the table above (notification, the Essential Principles, adverse event reporting, advertising rules and TGA action such as a recall). Only excluded software and software outside the device definition sits beyond TGA regulation.
Answering the question once for the whole product. A single product can carry a transcription feature, a calculator and an AI suggestion feature, and the medical device question is asked feature by feature. It is asked again after updates too: the TGA tells users to review updates and alerts, and its guidance is that an updated product, or one whose intended purpose changes, must be reassessed for whether it still meets the exclusion criteria.
Frequently asked questions
What does CDSS stand for?
Clinical decision support system, also written as clinical decision support software. The TGA's working definition is software that helps health professionals make decisions about patient care, providing prompts, alerts, reminders or recommendations based on clinical data. It can be a mobile app, cloud software, a website or a module inside an EMR or CIS.
Is clinical decision support software a medical device?
Sometimes. The manufacturer decides, based on the intended purpose. Three outcomes follow: not a medical device or excluded, in which case the TGA does not regulate it; a medical device that fits the item 2.15 exemption, which needs no ARTG entry but still carries sponsor obligations; or a medical device that is not exempt, which must be on the ARTG before it can be supplied in Australia.
Is AI clinical decision support exempt from the ARTG?
No. The TGA states that "an AI-enabled CDSS will not meet the exemption criteria", and that "Opaque CDSS do not meet exemption criterion (c) and are not exempt." An AI-enabled CDSS that is a medical device must be included in the ARTG before it can be supplied in Australia, unless another exemption applies.
Is a McIsaac or Centor score calculator a medical device?
Yes, but exempt. The TGA's Example 1 is a Clinical Information System that digitises the McIsaac (Modified Centor score) criteria for tonsillopharyngitis, and the verdict is "This CDSS is exempt." It is still a medical device, carrying the sponsor duties described above, but it does not need an ARTG entry.
Does the 1 November 2026 change apply to software we already use?
Yes. Regulation 11.90, inserted by F2026L01167, applies the new item 2.15 to a device manufactured on or after 1 November 2026 and to a device "manufactured before that commencement and is intended by its manufacturer to be used on or after that commencement". Software already installed in your practice is not carved out.
Can a symptom checker for patients use the CDSS exemption?
No. The TGA is explicit: "If your software provides decision support directly to patients (or any non-health professional user) it also does not qualify for the exemption." The item 2.15 exemption is confined to software intended to support health professionals in their decisions about patient care.
Is an AI scribe a clinical decision support system?
The TGA does not say. It regulates digital scribes under its own test on a separate page: a scribe that "analyses or interprets clinical conversations" by generating a diagnosis, differential diagnosis or treatment recommendation "not explicitly stated by the healthcare practitioner" is a medical device. We work through that test in our AI scribe entry.
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