Australia – TGA carves out exemptions for some software-based medical devices

Australia’s Therapeutic Goods Administration (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…