Australia – Update: TGA defines which digital mental health software it regulates

Australia’s medical device market regulator has issued new guidance on digital mental health device regulation. The Therapeutic Goods Administration (TGA) published the fact sheet to inform suppliers and providers when and how their software may be considered a medical device for regulatory purposes.

If you are a maker or distributor of any digital mental health tool, including apps that provide therapy or suicide prevention, internet-based counseling or symptom checkers, you will want to review these requirements to determine if and how you need to comply with TGA regulations…