Regulation of Medical Devices involving Software in Australia - an Overview

The Therapeutic Goods Administration (TGA) regulates the supply of therapeutic goods in Australia – including medical devices. Many medical devices are not programmable, electronic, or even electrical. However more devices are becoming programmable, and existing medical device software is becoming more complex. Currently in Australia, certain types of medical devices are subjected to extensive pre-market documentary evaluation by the TGA. However most devices have less scrutiny. It is proposed that medical device regulation in Australia will harmonise with the European Union Medical Device Directive. It is thereby hoped to: enhance requirements for many devices that are currently subject to few or no controls; reduce duplication for devices previously assessed by an overseas regulatory body; and to place increased emphasis on manufacturer quality and risk management systems and on postmarket surveillance. The intention is to address the safety of medical device software in its environmental context, and as a part of the device as a whole.