TGA Publishes List of AI-Enabled Medical Devices

On 4 September 2025, the Therapeutic Goods Administration (TGA) released a public list of medical devices included in the Australian Register of Therapeutic Goods (ARTG) that incorporate artificial intelligence (AI) or machine learning (ML) technologies. This initiative responds to stakeholder requests for greater regulatory transparency regarding AI use in healthcare products. 

To learn more about MedEnvoy’s Australian TGA Sponsor service, click here.

Purpose of the List 

The list was created using search criteria that identify AI/ML-related terms in the product name or intended purpose or based on sponsor declarations made since March 2025. Notably, the list may not capture all AI-enabled medical devices presently in the ARTG, owing to these search limitations.

Call to Action for Manufacturers and Sponsors 

Manufacturers or sponsors of AI-enabled devices seeking inclusion on the list are encouraged to reach out to the TGA via Digital.Devices@tga.gov.au 

Context & Related Regulatory Developments 

This publication aligns with broader TGA efforts to clarify and strengthen oversight of software-based medical devices, especially those involving AI. 

See also our website posts: TGA Focuses on AI and Software-Based Medical Devices  – MedEnvoy and Digital Scribes: TGA Guidance Overview.

How MedEnvoy Can Support 

MedEnvoy helps manufacturers and software developers navigate the related regulatory requirements by: 

• Assessing whether your AI or software solution qualifies as a regulated medical device 
• Supporting ARTG inclusion and liaising with the TGA 
• Advising on compliant labelling, advertising, and promotion 
• Offering ongoing monitoring of regulatory updates and enforcement actions 

With expertise across both traditional devices and digital health solutions, MedEnvoy ensures your products remain compliant and ready for market access in Australia. 

MedEnvoy offers expert regulatory support to manufacturers in navigating TGA regulation requirements. Our expertise ensures that your registration meets the applicable standards, enabling safe ongoing compliance. We encourage you to contact our team for tailored support. With expertise across both traditional devices and digital health solutions, MedEnvoy ensures your products remain compliant and ready for market access in Australia.