Clinical decision support system exemption amendments

The Therapeutic Goods Administration (TGA) has amended the Clinical Decision Support System (CDSS) exemption to provide greater clarity about when the exemption applies. The amendments come into effect from 1 November 2026. The amendments do not change the scope of the CDSS exemption or introduce new regulatory requirements.

Clinical decision support systems can perform a broad range of functions to support clinical practice and decision-making by health professionals. Where CDSS meets the definition of a medical device, it must generally be included in the Australian Register of Therapeutic Goods (ARTG) unless it is exempt or excluded. The CDSS exemption continues to apply to certain lower-risk CDSS that meet the exemption criteria.