Australia, 5 February 2026 — The Australian Therapeutic Goods Administration (TGA) has formally updated its regulatory guidance for medical devices that utilise Artificial Intelligence (AI) and Machine Learning (ML). This update strengthens the Artificial Intelligence Medical Device Software Regulation framework by clarifying when software qualifies as an Artificial Intelligence Medical Device and outlining the regulatory responsibilities for manufacturers and sponsors operating in the Australian market.
OVERVIEW OF ARTIFICIAL INTELLIGENCE (AI) AND MEDICAL DEVICE SOFTWARE REGULATION GUIDANCE
The TGA defines AI as software designed to mimic human intelligence and perform tasks autonomously. Under the Artificial Intelligence Medical Device Software Regulation, the following Artificial Intelligence Medical Device technologies are explicitly covered:
- Generative AI & LLMs: Large Language Models used for health advice or clinical recommendations.
- Adaptive & Deep Learning: Neural networks and machine learning models that evolve over time.
- Computer Vision & Robotics: Used in radiology image analysis, screening apps, and surgical assistance.
NLP & Expert Systems: Natural Language Processing and chatbots that suggest or monitor treatments.
TIMELINE & RESPONSIBILITIES
The publication triggers immediate compliance requirements for any developer whose software meets the definition of an Artificial Intelligence Medical Device:
- ARTG Inclusion: To be legally supplied in Australia, an Artificial Intelligence Medical Device must undergo pre-market assessment and be included in the Australian Register of Therapeutic Goods (ARTG).
- Managing Scope Creep: Manufacturers must continuously monitor software updates. If a new feature, such as a digital scribe adding diagnostic suggestions, alters the intended purpose of an Artificial Intelligence Medical Device, regulatory approval must be obtained before the update is released.
- Off-Label Use: When a manufacturer becomes aware that a general-purpose AI system is being used for medical diagnosis, they must either implement controls to prevent such use or cease supply and seek TGA approval to register the product as an Artificial Intelligence Medical Device for the new intended purpose.
- Evidence Requirements: Manufacturers are required to maintain transparent and robust evidence demonstrating the safety and performance of Artificial Intelligence Medical Devices, including documented justifications for the use of synthetic data in training, validation, or testing.
RESOURCES
To help companies navigate these requirements, the TGA and related bodies have provided the following resources:
- ARTG List: List of AI-enabled medical devices already in the ARTG.
- General Guidance: How the TGA regulates software products.
- Direct Support: Manufacturers can email [email protected] for clarification or request a formal pre-submission meeting.
- Whole-of-Government Oversight: Coordination with the Australian Commission for Safety and Quality in Health Care regarding e-Health safety.