TGA Focuses on AI and Software-Based Medical Devices 

The Therapeutic Goods Administration (TGA) has published a new regulatory focus on artificial intelligence (AI) and other software-based medical devices. This marks a step-up in oversight to ensure that digital health technologies comply with Australia’s medical device regulations. 

For more information about MedEnvoy’s TGA Sponsor service, click here.

Key Findings

As part of this new approach, the TGA is: 

• Encouraging voluntary compliance from developers and suppliers 

• Publishing clearer and more consistent guidance 

• Acting on complaints and reports of non-compliance 

• Investigating unlawful advertising and supply practices 

A current TGA priority is the review of AI-powered digital scribes. As highlighted in our news update on TGA Guidance on Digital scribes, these tools are evolving beyond documentation support to include diagnostic and treatment suggestions. Such advanced features may bring them under the definition of a medical device in the Therapeutic Goods Act 1989. Where this is the case, inclusion in the Australian Register of Therapeutic Goods (ARTG) is required before supply or promotion, unless exempt or excluded. 

For more information, click here: TGA focuses on compliance of AI and software-based medical devices | Therapeutic Goods Administration (TGA) 

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.