TGA Clarifies Exclusion for Digital Mental Health Software

The Australian Therapeutic Goods Administration (TGA) published guidance on 16 March 2026 clarifying when software products intended to support users’ mental health are excluded from medical device regulation under item 14E of the Therapeutic Goods (Excluded Goods) Determination 2018. The exclusion applies to digital mental health tools (DMHTs) including cognitive behavioral therapy (CBT) apps and websites that are based on established clinical practice guidelines, provided those guidelines are clearly referenced and accessible to users within the software itself. Products meeting all four conditions of the exclusion do not require inclusion in the Australian Register of Therapeutic Goods (ARTG). Software that forms part of a novel treatment still undergoing clinical trials is explicitly not covered and may require a separate exemption application. 

What Manufacturers and Software Developers Need to Know 

This guidance provides meaningful clarity for software developers and manufacturers operating in the digital mental health space, a category that has historically sat in a regulatory grey area. The four-question test, focused on mental health intent, reliance on established guidelines, in-software referencing, and user accessibility of those guidelines, creates a practical framework for self-assessment. Notably, the TGA has confirmed that the guideline need not come exclusively from a major national body; guidelines published by a hospital or a recognized individual expert may also qualify, provided they are widely accepted in Australian clinical practice. 

Software developers and manufacturers distributing mental health applications or websites in Australia should carefully review their products against the four conditions of exclusion 14E. Products that rely on innovative or proprietary treatment approaches not yet recognized in established Australian clinical practice guidelines will not qualify for the exclusion and must be registered on the ARTG before supply. Manufacturers should also ensure that any referenced clinical guidelines are surfaced directly within the product interface, as links buried in user manuals or external documentation are explicitly insufficient under the TGA’s criteria. 

How MedEnvoy Can Support  

Determining whether a digital health software product qualifies for the DMHT exclusion requires a careful assessment of both the product’s intended purpose and the standing of the clinical guidelines it relies upon. MedEnvoy offers Australian Sponsor Representative services to medical device manufacturers and software developers entering the Australian market and can assist in conducting that exclusion assessments. Where a product does not meet the exclusion criteria, we support manufacturers through the full ARTG registration pathway, including exemption applications where applicable. 

Learn more about our Australian Sponsor Representative support.

Questions on how MedEnvoy can assist with your Australian market access strategy? Contact us today.