Australia issues guidance on requirements for devices register
This article was originally published in Clinica
Executive Summary
The Australian Therapeutic Goods Administration (TGA) has issued its fourth medical devices guidance document aimed at explaining the new regulatory system for medical devices in Australia that commenced in October 2002 (see Clinica No 1028, p 12). Entitled the "clinical evidence requirements for inclusion of medical devices in the Australian register of therapeutic goods", the document describes the mechanics for demonstrating compliance with the essential principles, defined for each class of medical device.