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Clinical decision support software

Scope and examples
18 February 2021
Download Clinical decision support software

Description

From 25 February 2021, the way that software-based medical devices are regulated in Australia will change. 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
  • How to determine if your clinical decision support software is regulated by the TGA
  • What to do if your clinical decision support software is exempt
  • What to do if your clinical decision support software is regulated by the TGA

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