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
Topics