The Therapeutic Goods Administration (TGA) Australia has released a factsheet on software based medical devices in digital mental health in May 2022.
Some examples of these medical devices include any app that offers therapy, internet-based services, devices that monitor symptoms, and suicide prevention apps.
Any digital mental health software will be under TGA’s regulation if it fits the criteria of a medical device.
There is an accreditation model for digital mental health service providers, where there will be assessments in accordance with the National Safety and Quality Digital Mental Health (NSQDMH) Standards. The assessments are expected to start in the second half of 2022.
More details can be found in “Digital Mental Health: Software based medical devices, May 2022”: https://www.tga.gov.au/sites/default/files/digital-mental-health-software-based-medical-devices.pdf