TGA Amends Clinical Decision Support System Exemption
The Therapeutic Goods Administration, TGA, has published amendments to the Clinical Decision Support System, CDSS, exemption.
The amendments are intended to provide greater clarity about when the CDSS exemption applies and will come into effect from 1 November 2026.
Scope of the Amendments
The TGA states that the amendments do not change the scope of the CDSS exemption and do not introduce new regulatory requirements.
This means the update is focused on clarification rather than expanding or narrowing the existing exemption.
Clinical Decision Support Systems
The publication explains that clinical decision support systems can perform a broad range of functions to support clinical practice and decision-making by health professionals.
Where a CDSS meets the definition of a medical device, it generally must be included in the Australian Register of Therapeutic Goods, ARTG, unless it is exempt or excluded.
Continued Application of the Exemption
The CDSS exemption continues to apply to certain lower-risk CDSS that meet the exemption criteria.
For developers, manufacturers and sponsors of digital health software, the update reinforces the importance of assessing whether a CDSS meets the definition of a medical device and whether it qualifies for an exemption or exclusion.
Impact on Digital Health and Medical Device Software Stakeholders
For CDSS developers, medical device software manufacturers, sponsors and regulatory teams, the amendment is relevant because it clarifies how the exemption applies without creating new requirements.
Stakeholders should pay particular attention to:
whether the software meets the definition of a medical device;
whether the CDSS is exempt or excluded;
whether the CDSS meets lower-risk exemption criteria;
ARTG inclusion requirements;
regulatory classification strategy;
product claims and intended purpose;
implementation date of 1 November 2026;
documentation supporting exemption applicability.
For companies developing or supplying CDSS in Australia, the key message is that the exemption framework remains in place, but the TGA has amended it to make its application clearer.
