Australia’s Therapeutic Goods Administration (TGA) has updated its guidance “Understanding clinical decision support system software regulation” on 16 October 2026.
The document explains how Clinical Decision Support System (CDSS) software is regulated and when such software may be excluded from regulation, exempt from inclusion in the Australian Register of Therapeutic Goods (ARTG), or subject to full medical device requirements. 1792217310129
The guidance is also currently under review to align with amendments coming into effect on 1 November 2026. 1792217310129
What Is CDSS Software?
TGA describes CDSS as software capable of performing a broad range of functions that enable or support clinical practice.
Examples include:
web-based tools providing disease or condition information based on practitioner input;
software assisting radiologists with image interpretation;
software collecting data from closed-loop blood glucose monitoring systems. 1792217310129
CDSS may take many forms, including mobile apps, cloud-based software, websites, digital scribes and traditional software platforms. 1792217310129
Excluded vs Exempt Software
A key distinction in the guidance is between software that is excluded and software that is exempt.
If all CDSS functions fall within the exclusions under the Therapeutic Goods (Excluded Goods) Determination 2018, the software is not regulated by TGA. 1792217310129
By contrast, exempt CDSS remains a medical device but does not need to be included in the ARTG.
It remains subject to regulatory oversight, including obligations relating to:
advertising;
adverse event reporting;
notification;
compliance with the Essential Principles. 1792217310129
When CDSS May Be Exempt
Some CDSS software that meets the definition of a medical device may qualify for exemption from ARTG inclusion.
TGA notes that exempt CDSS typically has more limited functionality and may collect, perform simple analysis on, or display information from:
Electronic Medical Records;
Electronic Health Records;
Clinical Information Systems. 1792217310129
Such tools may provide prompts, alerts, reminders or recommendations to help health professionals apply evidence-based guidelines or hospital procedures.
More advanced software that specifies a diagnosis or treatment is unlikely to qualify. 1792217310129
Three-Step Assessment
TGA recommends a three-step approach to determining whether CDSS qualifies for exemption:
Is the software a medical device?
Is it intended to support a health professional in making clinical decisions?
Does it meet all three exemption criteria? 1792217310129
If the software is not a medical device, or is already excluded, the exemption analysis is unnecessary. 1792217310129
Exemption Criterion 1: Recommendation Only
To qualify for exemption, the software must be intended solely to provide or support a recommendation to a health professional about prevention, diagnosis, treatment or alleviation of disease or injury. 1792217310129
TGA explains that the software may help clinicians make decisions, but must not itself:
diagnose or screen for a condition;
determine treatment;
override clinical judgement;
provide patient monitoring information. 1792217310129
Exemption Criterion 2: No Direct Image or Signal Analysis
The software must not directly process or analyse:
X-rays, MRI or CT images;
ECG or other patient-monitor signals;
blood pressure or glucose sensor data;
information from IVD medical devices. 1792217310129
Software that merely displays or retrieves this information from an EMR may still qualify.
However, if it interprets the data, generates a result or uses it for patient monitoring, the exemption does not apply. 1792217310129
Exemption Criterion 3: Clinical Judgement Must Remain With the Professional
The software must not be intended to replace a health professional’s clinical judgement.
To meet this criterion, TGA expects recommendations to be transparent and independently verifiable.
The software should:
explain how recommendations are generated;
allow clinicians to verify their accuracy;
reference the logic, guideline, process or evidence underlying the recommendation. 1792217310129
Transparency and “Black Box” Systems
The guidance places particular emphasis on transparency.
TGA describes transparent tools, such as computerised flowcharts based on published clinical guidelines, as systems whose logic can be reviewed by the clinician. 1792217310129
By contrast, opaque or “black box” systems provide outputs without exposing their internal reasoning.
TGA states that opaque CDSS does not meet exemption criterion (c) and is not exempt. 1792217310129
Examples of Exempt CDSS
TGA provides several examples of software that may qualify for exemption.
These include:
a clinical scoring tool based on the McIsaac score;
an asthma management module based on published guidelines;
a venous thromboembolism risk assessment tool;
an ICU EMR tool flagging relevant clinical parameters and linking recommendations to known protocols. 1792217310129 1792217310129 1792217310129
The common feature is that the clinician can understand the basis of the recommendation and retains responsibility for the final decision.
Examples of Non-Exempt CDSS
The guidance also gives examples that do not qualify for exemption.
A diabetes tool that directly returns a diagnosis is not exempt because it performs a diagnostic function. 1792217310129
A system that analyses dental X-rays and identifies additional pathologies is also not exempt because it directly analyses medical images and generates outputs that are not transparent or independently verifiable. 1792217310129
Similarly, a proprietary sepsis tool that monitors clinical parameters and generates treatment recommendations is not exempt because it performs monitoring functions and does not expose the logic underlying its recommendations. 1792217310129
Machine Learning and Wound Management
TGA also describes a wound-management app that uses a smartphone camera and machine learning to classify tissue and generate care plans.
The software is not exempt because it performs diagnostic functions and relies on a machine learning algorithm that is not transparent to the clinician. 1792217310129
Regulatory Requirements for Exempt CDSS
Even when CDSS is exempt from ARTG inclusion, manufacturers and sponsors still have regulatory responsibilities.
Sponsors must notify TGA within 30 working days of supplying an exempt CDSS using the relevant exemption notification form. 1792217310129
Exempt software must also:
comply with the Essential Principles;
remain subject to potential regulatory action;
meet adverse event reporting obligations;
comply with advertising requirements. 1792217310129
Important 2026 Update
The page history shows that the 16 October 2026 update:
added a note that the guidance is under review;
added digital scribes to the software examples;
removed explicit mention of AI from the exemption criteria section. 1792217310129
However, the guidance continues to make clear that opaque systems are not exempt, regardless of whether they use machine learning or another technology. 1792217310129
Impact on Digital Health Developers
For software manufacturers, sponsors and digital health developers, the guidance reinforces the importance of correctly determining whether a CDSS is:
not a medical device;
excluded from regulation;
exempt from ARTG inclusion;
fully regulated as a medical device.
The intended purpose, level of analysis, transparency of the algorithm and role of the healthcare professional all remain central to that determination.
Developers should also reassess regulatory status when software is updated or its intended purpose changes.
