The TGA reviewed 12 digital-scribe products supplied in Australia. Eight included functions likely to meet the medical-device definition, two required further information and two appeared unlikely to be medical devices.

Classification depends on intended purpose and functionality, especially whether the software analyses information or generates patient-specific clinical recommendations, conclusions or outputs. The TGA will use education, guidance and targeted, proportionate compliance activity under the existing medical-device framework.

Impact

Impact assessment: High.

Key reasons: Eight of the twelve reviewed products contained functions likely to be medical devices, creating immediate classification, ARTG, evidence, labelling and compliance questions under existing law.

Who is affected?

Digital-scribe developers and suppliers, Australian sponsors, healthcare providers, clinicians, software quality teams, regulatory affairs teams and organisations deploying AI-enabled clinical documentation tools.

Conclusion:

Assess each product at feature level, document intended purpose, determine whether regulated or exempt CDSS provisions apply, close ARTG and conformity gaps, and prepare for risk-based TGA compliance activity. Do not assume that transcription branding or a disclaimer removes medical-device obligations.