Consultation: clarification of how Clinical Decision Support System (CDSS) software is regulated

While the consultation is open you can make a submission at our consultation hub. 

We review the submissions. After that the submissions and our decision will be available on the same consultation page.

About this consultation

We are seeking feedback on proposed regulatory clarifications for Clinical Decision Support System (CDSS) software.

The Australian Government is undertaking a significant program of reform to the regulation of therapeutic goods in Australia. The reforms aim to improve the safety, performance, and quality of medical devices in Australia and improve health outcomes for patients who require medical devices. 

There is currently a regulatory exemption in place for certain Clinical Decision Support Systems (CDSS) if they meet specific criteria. We have issued this consultation paper to seek feedback on a number of proposed clarifications to the exemption, and are seeking views on what further information or regulatory guidance is required by stakeholders.

This is the third consultation paper published by the TGA relating to software based medical products. It builds on two previous consultation papers, Regulation of software, including Software as a Medical Device (SaMD) in 2019 and Scope of Regulated Software based products in 2020.

We invite you to review this third consultation paper and provide a response using our online survey, both of which are accessible through our TGA Consultation Hub. We appreciate all views, so if you would prefer to respond by email or written document, you can find further details on the hub.

This consultation will inform the policy decisions that will be made by the Australian Government.