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
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.