Reviews conducted by Australia’s Therapeutic Goods Administration (TGA) found “clear examples” of harm caused by medical software. TGA searched the medical literature for articles on the safety and ...

Respondents to a consultation by Australia’s Therapeutic Goods Administration (TGA) on the scope of regulations governing software as a medical device (SaMD) offered broad support for the regulatory ...

PERTH, Australia – Australia’s TGA issued new guidance to help device manufacturers better understand new classifications for active medical devices, including software-based medical devices, and ...

PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) released guidance for sponsors and manufacturers on regulatory requirements for software to be used with COVID-19 rapid antigen ...