What the review established
On October 16, 2026, Australia’s Therapeutic Goods Administration (TGA) published its digital scribe review. Eight of 12 selected products contained functions likely to meet the medical-device definition; two required more information and two appeared unlikely to qualify. The review did not test products or assess safety, performance, detailed regulatory compliance, privacy or data protection.
These findings do not establish eight violations or a market-wide non-compliance rate. The report describes findings under the existing framework; it does not create new legal obligations.
Documentation and clinical outputs require different assessments
The TGA’s digital scribe guidance distinguishes administrative documentation from additional clinical content. Tools limited to recording, transcription, translation or organisation of consultations, without adding clinical content or suggestions not explicitly stated by the health professional, are generally outside the medical-device definition. Functions generating diagnostic or treatment suggestions may fall within it.
Consider a hypothetical update that changes a transcription tool into one that proposes investigations absent from the consultation. The same product name and clinician approval step would not resolve the regulatory question. The added function needs its own assessment. Similarly, formatting a referral letter differs from deciding which history matters clinically and recommending an investigation. These examples illustrate the assessment; they do not determine any named product’s status.
Intended purpose must match claims and functionality
The TGA’s general software guidance identifies intended purpose through materials such as instructions, labelling, technical documentation and advertising. Its advertising guidance also explains that therapeutic claims can establish a medical purpose. A claim to guide diagnosis or treatment therefore matters even where the interface carries a general disclaimer. A disclaimer alone cannot negate a therapeutic function.
For product teams, a useful analytical check is to describe the inputs, processing and outputs together, then compare that description with the instructions and promotional material. Software updates introducing diagnostic support, treatment recommendations or clinical monitoring require reassessment of regulatory status. An earlier assessment of an administrative tool does not automatically cover subsequent versions.
The CDSS exemption is conditional
Some clinical decision support system (CDSS) software is exempt from inclusion in the Australian Register of Therapeutic Goods (ARTG), while remaining a regulated medical device.
Under the provisions in force on October 17, 2026, the exemption requires all three intended-purpose criteria:
- The sole purpose is to provide or support recommendations to health professionals concerning prevention, diagnosis, cure or alleviation of disease, ailment, defect or injury in people.
- The software is not intended to directly process or analyse medical images or signals from another medical device, including an in vitro diagnostic device.
- It is not intended to replace professional clinical judgement in diagnosis or treatment decisions.
The current CDSS guidance distinguishes simply retrieving or displaying information from an electronic medical record from direct analysis of device-derived inputs. It also requires transparency sufficient for clinicians to understand and independently verify recommendations. A confirmation button alone does not meet that test, and opaque outputs do not qualify.
Exempt products still face applicable obligations, including Essential Principles for safety and performance, conformity assessment, notification and adverse-event reporting. Exemption from ARTG inclusion does not remove medical-device oversight.
Separate amendments to the exemption take effect on November 1, 2026. The TGA says they clarify the wording without changing its scope or introducing new requirements; the supporting guidance remains under review. Teams supplying or updating products after that date should check the applicable text.
For a digital scribe, the practical starting point is to separate documentation from clinical recommendation functions, establish each function’s intended purpose, and then assess any exemption against its conditions.
Sources
- Primary official sourceDigital scribe review outcomes (opens in a new tab)Therapeutic Goods Administration
- Supporting sourceDigital scribes (opens in a new tab)Therapeutic Goods Administration
- Supporting sourceUnderstanding how we regulate software-based medical devices (opens in a new tab)Therapeutic Goods Administration
- Supporting sourceAdvertising software-based medical devices in Australia (opens in a new tab)Therapeutic Goods Administration
- Supporting sourceUnderstanding clinical decision support system software regulation (opens in a new tab)Therapeutic Goods Administration
- Supporting sourceTherapeutic Goods (Medical Devices) Regulations 2002, Schedule 4, Part 2, item 2.15 (opens in a new tab)Australian Government, Federal Register of Legislation
- Supporting sourceExempt software as a medical device (opens in a new tab)Therapeutic Goods Administration
- Supporting sourceQuality, safety, and performance requirements for medical devices (the Essential Principles) (opens in a new tab)Therapeutic Goods Administration
- Supporting sourceClinical decision support system exemption amendments (opens in a new tab)Therapeutic Goods Administration