Posts with tag Medical Software

In December 2019 the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019 was passed as part of measures to more closely align Australian therapeutic goods regulations with the European Medical Device Regulation 2017/745. As part of these changes, new medical device regulations will enter force on 25 August 2020 to specifically address the growing Software as a Medical Device (SaMD) sector. The regulatory framework for medical devices in Australia...