Medical software assessment starts with intended use
Device status for software depends on intended use and actual functions, including any applicable exclusion or exemption. A health-related app or software using AI does not automatically require the same type of registration.
Explain functions, outputs and decision-making
Clarify software inputs, outputs, users and effects on diagnosis, treatment or other clinical decisions. Cloud, phone or desktop deployment alone does not establish intended use.
Prepare software evidence under the applicable pathway
After confirming regulatory applicability, review risk classification, software documentation, verification and validation, clinical evidence and safety information to create a staged preparation plan.
Official references
- TGA — Understanding how we regulate software-based medical devices
- TGA: steps to supply medical devices for Sponsors
Sources checked: 2026-09-11. Assess individual products and projects against current applicable requirements.