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.
Frequently asked questions
Does every AI or health-related software product need TGA registration?
Software status depends primarily on intended purpose and function, not whether it uses AI, runs on a phone or is free. Assess functions such as diagnosis, treatment recommendations or clinical monitoring, together with any applicable exclusion or exemption. Prepare a functional description, input and output examples, target users and promotional materials so the assessment reflects actual use. Calling a product a wellness tool does not replace a review of its functions and purpose.
Official sources:TGA — Understanding how we regulate software-based medical devices
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Do software feature updates require a new regulatory assessment?
Assess whether an update changes intended purpose, clinical function or risk rather than judging regulatory significance from the version number. New diagnostic support, treatment recommendations or user populations may change the original assessment. Existing device software also requires review of classification and continuing compliance after changes. Keep a version comparison, validation records and affected uses, and review the regulatory implications before release so technical updates align with labelling, evidence and application arrangements.
Official sources:TGA — Understanding how we regulate software-based medical devices
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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.
