TGA clarifies the clinical decision support system exemption: What should software developers check?

From 1 November 2026, amended wording will clarify when Clinical Decision Support System (CDSS) software qualifies for exemption from inclusion in the Australian Register of Therapeutic Goods (ARTG). The Therapeutic Goods Administration (TGA) has stated that the amendments do not change the scope of the exemption or introduce new regulatory requirements. However, they make several boundaries clearer for manufacturers and sponsors assessing their software.

CDSS software can support a health professional’s clinical decisions in many ways. Whether a particular product qualifies for the exemption depends on its intended purpose and functions, rather than its description as “decision support” alone. Under the amended wording, exempt software must be intended to make a recommendation to a health professional solely to assist that professional in making a decision. It must not be intended to replace their clinical judgement or make a clinical diagnosis or treatment decision itself. The amendment expressly clarifies that the latter restriction also applies to IVD software.

What has been clarified?

Medical images and signals. To qualify for the exemption, the software must not be intended to process, analyse, compress or decompress a medical image or signal from another medical device. The previous reference to directly processing or analysing an image or signal has been removed. Developers should consider the full function of the software, including any processing that occurs before a recommendation is displayed.

Diagnosis and treatment decisions. The amended provision makes explicit that software intended to make a clinical diagnosis or decide on treatment does not qualify for this exemption. A recommendation that assists a health professional needs to be distinguished from an output that makes the decision for them.

Verifiable recommendations. The software must display details of the clinical practice guidelines, calculations or logic it uses so that a health professional can readily interpret and verify its recommendations while using the software in its intended clinical context. Developers should therefore consider what information is visible in the user interface at the point of use, as well as what is documented elsewhere.

What should manufacturers and sponsors do?

If you consider your device exempt under the CDSS exemption, review its software intended purpose, promotional claims, inputs, processing steps and displayed outputs against the amended wording. In particular, consider whether the health professional can verify the basis for a recommendation during normal use.

The amendment applies from 1 November 2026, including to software manufactured earlier that is intended for use on or after that date. Software that does not meet the exemption criteria may need another regulatory pathway, depending on its intended purpose and functions.

Exemption from ARTG inclusion does not remove all regulatory obligations. Exempt CDSS remains subject to applicable requirements, including compliance with the Essential Principles, notification to the TGA, adverse event reporting and advertising requirements.

KD&A can assist manufacturers and sponsors in assessing whether their software qualifies for the CDSS exemption or requires inclusion in the ARTG.