TGA has published the Therapeutic Goods (Excluded Goods) Amendment (Software-Based Products) Determination 2021, which will become effective on February 25, 2021. This amends the Therapeutic Goods (Excluded Goods) Determination 2018 to identify software-based devices, including software as a medical device (SaMD), that are excluded from the TGA’s medical device regulatory framework and should not be included in the Australian Register of Therapeutic Goods (ARTG). There are 15 software types identified here as excluded goods.

Categories of software-based devices exempted from TGA regulation

• Consumer health products for preventing or managing conditions, monitoring vital signs, providing health and wellness coaching, and collecting patient-reported outcome measures (PROMs)
• Digital mental health tools, including cognitive behavior therapy tools
• Products designed to enable communications, management of health processes or facilities, clinical workflow management, or notification of health professionals
• Software used solely to store or transmit patient images
• Middleware used to connect applications within a healthcare system
• Software designed to make calculations using clinical data
• Electronic health records and data analytics software
• Laboratory information management systems

Many of the software-based product descriptions include additional criteria that must be met if the products are to qualify for exemption from regulation, such as the requirement that the software is not intended to provide diagnosis, screening, treatment recommendations, etc.