Australia · Regulation
Australia's clinical decision support software exemption amendments
Amendments clarify the clinical decision support system exemption from November 1, 2026. TGA says they do not change its scope or introduce new regulatory requirements.
About this rule
The Therapeutic Goods Legislation Amendment (2026 Measures No. 1) Regulations 2026 clarifies the exemption criteria for lower-risk clinical decision support software. Software meeting the medical-device definition generally requires inclusion in the Australian Register of Therapeutic Goods unless exempt or excluded. The registered instrument is the controlling source for the exact criteria; the exemption is not a general exemption for all clinical AI.
- Agency
- Therapeutic Goods Administration
- Instrument
- F2026L01167
- Published
- Sep 8, 2026
- Effective
- Nov 1, 2026
Who it affects
Developers and suppliers of clinical decision support software used by health professionals in Australia.