Tag: TGA

Healthcare, Industry News, Medical Devices, Regulatory Affairs

Australia’s Therapeutic Goods Administration carves out exemptions for some software-based medical devices

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 […]

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