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Clinical decision support software

Scope and examples
11 October 2021
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Description

Changes to the way that software-based medical devices are regulated in Australia came into effect on 25 February 2021. Information about the changes can be found in Regulatory changes for software based medical devices.

Clinical decision support software (CDSS) that meets the definition of a medical device must be included in the Australian Register of Therapeutic Goods (ARTG) unless otherwise exempt. Under the changes, an exemption has been introduced for some CDSS that is a medical device. Note, CDSS that does not meet the definition of a medical device, or is excluded, is not subject to regulation by the TGA.

  • About this guidance
    • Excluded or exempt software
    • Exemption for clinical decision support software
  • How to determine if your clinical decision support software is regulated by the TGA
    • Is it a medical device?
      • Examples of CDSS that is not a medical device
    • Is it excluded?
    • Is it exempt?
      • Examples of CDSS that is exempt
      • What to do if your clinical decision support software is exempt
      • Examples of CDSS that is not exempt
      • What to do if your clinical decision support software is regulated by the TGA

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