Compliance · Australia
Clinical AI: establish intended purpose and medical-device status
Clinical AI: establish intended purpose and medical-device status. Existing therapeutic-goods framework. Check coverage for each AI use case.
TGA regulation depends on intended purpose, not the AI label. Relevant software generally needs ARTG inclusion before lawful supply unless an exclusion or exemption applies. Added functionality can change regulatory status.
Use-case investigation: retain manufacturer and sponsor identity, product version, intended purpose, ARTG or exemption evidence, clinical suitability, patient-information arrangements and clinician review. Separate administrative transcription from diagnostic or treatment recommendations. Reassess supplier or functionality changes rather than assuming one approval covers every later use.
Official source
Therapeutic Goods Administration · Source checked:
NORMIX editorial summary and practical commentary. Check the official source for scope and current requirements.
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