Compliance · Australia

TGA review: AI scribes need a function-by-function regulatory check

Published on NORMIX: 2026-10-22 · NORMIX

TGA findings published on 16 October 2026 reinforce the need to check an AI scribe’s actual functions and regulatory basis, alongside privacy and clinical oversight.

The TGA examined 12 digital-scribe products. None of their suppliers identified them as medical devices. The regulator found eight had functions likely to meet the device definition, two needed more information, and two appeared unlikely to be devices on the available information. These findings are not a finding that every product is unlawful, nor a safety-performance or privacy assessment.

The accompanying Digital scribes guidance distinguishes documentation functions from functions with a therapeutic purpose. An administrative-use label alone does not settle classification.

NORMIX practical takeaway: record the product version, functions and intended use; request supplier ARTG, exclusion or exemption evidence where applicable; and document clinician review, patient information, change control and incident responsibilities. Seek specialist device advice where classification is unresolved. This is regulatory interpretation under existing legislation, not a new AI statute.