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Exemption for Certain Clinical Decision Support Software

Guidance

TGA has designed detailed guidance for Exempt Clinical Decision Support Software which complements the general guidance already published

Last updated

This guidance is for sponsors, manufacturers, suppliers, and software developers of Exempt Clinical Decision Support Software (CDSS) and provides detailed interpretation of the exemption criteria for certain CDSS. This document complements the general guidance on CDSS that was published by the TGA in February 2021.

  • About this guidance
  • Background
  • Scope of regulated Clinical Decision Support Software
  • Exemption criteria
    • Exemption criteria: Explanatory table
  • Where do I go if I have more questions?
  • Appendix A: CDSS characteristics
  • Appendix B: Clinical settings and scenarios
  • Version history

Supporting documents

This webpage on the TGA website was printed on 18 Sep 2024. Printed content may be out of date. For up-to-date information, always refer to the digital version: https://www.tga.gov.au/resources/resource/guidance/exemption-certain-clinical-decision-support-software

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