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

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Closes 6 May 2024


The Therapeutic Goods Administration (TGA) is conducting a public consultation to give stakeholders an opportunity to comment on a number of proposed regulatory clarifications to the exemption for CDSS software, and on what further information or regulatory guidance is required by stakeholders. This consultation will also aim to address emerging concerns about the safety and performance of available CDSS software products.

The TGA is not intending to change the intent of the current CDSS software policy which was developed to:

  • Manage risks associated with software products appropriately.
  • Align with other jurisdictions around the world, including the EU.
  • Provide a reduced regulatory burden for low-risk CDSS software products.

This consultation aims to address questions and areas of uncertainty regarding interpretation of the Regulations and guidance applicable to CDSS software with a view to refining and clarifying Australia’s current requirements for exempt CDSS software only.