Navigating the Regulatory Landscape of Artificial Intelligence in A ustralian Clinical Dentistry

Artificial intelligence (AI) is rapidly transforming clinical dentistry, with an increasing number of AI-powered diagnostic and treatment planning tools entering the Australian healthcare market. As clinicians adopt AI-based dental software, it is becoming increasingly important to understand the regulatory frameworks that govern them. This narrative review explores the regulatory approval pathways and governance of AI tools used in Australian dental and healthcare settings to inform and educate practitioners. Australia regulates AI-based dental software primarily through the Therapeutic Goods Administration, which classifies eligible products as software as a medical device under a risk-based, technology-agnostic framework established by the Therapeutic Goods Act 1989. AI tools that function as clinical decision-support systems are subject to mandatory conformity assessment and registration on the Australian Register of Therapeutic Goods (ARTG) prior to lawful supply. Although the Australian framework aligns with the International Medical Device Regulators Forum principles, the approval process is comparatively less transparent than that required in jurisdictions such as the United States and the European Union, and questions remain regarding the consistency of post-market oversight. This review also highlights emerging regulatory challenges associated with adaptive AI systems. Software could initially receive approval as a low-risk device that evolves to provide specific clinical advice beyond its approval scope. These updates to functionality risk bypassing established oversight pathways that rely on self-reported intended use. Furthermore, currently available AI tools lack comprehensive public-facing transparent evidence for regulatory compliance that is complicated by ambiguous and inconsistent terminology and adaptive AI system classification. Regardless of regulatory approval, clinicians remain professionally accountable for the use of AI tools in clinical decision-making and for ensuring that patient care meets accepted standards of practice.