{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T04:49:35Z","timestamp":1792126175976,"version":"4.4.0"},"reference-count":44,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T00:00:00Z","timestamp":1792022400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T00:00:00Z","timestamp":1792022400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Australian Dental Journal"],"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>Artificial intelligence (AI) is rapidly transforming clinical dentistry, with an increasing number of AI\u2010powered diagnostic and treatment planning tools entering the Australian healthcare market. As clinicians adopt AI\u2010based 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\u2010based dental software primarily through the Therapeutic Goods Administration, which classifies eligible products as software as a medical device under a risk\u2010based, technology\u2010agnostic framework established by the Therapeutic Goods Act 1989. AI tools that function as clinical decision\u2010support 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\u2010market oversight. This review also highlights emerging regulatory challenges associated with adaptive AI systems. Software could initially receive approval as a low\u2010risk 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\u2010reported intended use. Furthermore, currently available AI tools lack comprehensive public\u2010facing 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\u2010making and for ensuring that patient care meets accepted standards of practice.<\/jats:p>","DOI":"10.1111\/adj.70078","type":"journal-article","created":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T04:41:05Z","timestamp":1792125665000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Navigating the Regulatory Landscape of Artificial Intelligence in\n                    <scp>A<\/scp>\n                    ustralian Clinical Dentistry"],"prefix":"10.1111","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3924-2133","authenticated-orcid":false,"given":"Rishi","family":"Ramani","sequence":"first","affiliation":[{"name":"Dentistry Data and Artificial Intelligence (D2AI) Research Group, Melbourne Dental School The University of Melbourne  Melbourne Victoria Australia"},{"name":"Oral Medicine and Oral Cancer (OMOC) Research Group, Melbourne Dental School The University of Melbourne  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9502-3410","authenticated-orcid":false,"given":"Arosha","family":"Weerakoon","sequence":"additional","affiliation":[{"name":"School of Dentistry The University of Queensland  Herston Queensland Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8412-1114","authenticated-orcid":false,"given":"Tami","family":"Yap","sequence":"additional","affiliation":[{"name":"Dentistry Data and Artificial Intelligence (D2AI) Research Group, Melbourne Dental School The University of Melbourne  Melbourne Victoria Australia"},{"name":"Oral Medicine and Oral Cancer (OMOC) Research Group, Melbourne Dental School The University of Melbourne  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8558-9405","authenticated-orcid":false,"given":"Bree","family":"Jones","sequence":"additional","affiliation":[{"name":"Dentistry Data and Artificial Intelligence (D2AI) Research Group, Melbourne Dental School The University of Melbourne  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,10,15]]},"reference":[{"key":"e_1_2_13_2_1","unstructured":"Department of Industry SaR \u201cIntroducing Mandatory Guardrails for AI in High\u2010Risk Settings \u201d2024."},{"issue":"7","key":"e_1_2_13_3_1","doi-asserted-by":"crossref","first-page":"769","DOI":"10.1177\/0022034520915714","article-title":"Artificial Intelligence in Dentistry: Chances and Challenges","volume":"99","author":"Schwendicke F.","year":"2020","journal-title":"Journal of Dental Research"},{"key":"e_1_2_13_4_1","unstructured":"Department of Industry SaR \u201cNational AI Plan \u201d2025."},{"key":"e_1_2_13_5_1","unstructured":"Dental Board of Australia \u201cCode of Conduct for Dental Practitioners \u201d2022."},{"key":"e_1_2_13_6_1","unstructured":"Australian Government Department of Health and Aged Care \u201cSafe and Responsible Artificial Intelligence in Health Care: Legislation and Regulation Review \u2013 Final Report \u201d2025."},{"key":"e_1_2_13_7_1","volume-title":"Consultation: Clarifying and Strengthening the Regulation of AI in Medical Devices","author":"Therapeutic Goods Administration","year":"2024"},{"issue":"4","key":"e_1_2_13_8_1","doi-asserted-by":"crossref","first-page":"209","DOI":"10.1111\/adj.70000","article-title":"Artificial Intelligence in Australian Dental and General Healthcare: A Scoping Review","volume":"70","author":"Weerakoon A. 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