Abridged assessments for medical devices previously registered or listed in the Australian Register of Therapeutic Goods (ARTG)
In October 2002 the TGA introduced a new regulatory system for medical devices, with a five year transition period for devices supplied in Australia at the time of implementation of the new system. As from 4 October 2007, medical devices currently Registered or Listed in the ARTG must be "Included" in the ARTG. There is no "automatic" transition - sponsors must apply for inclusion and the devices must have been assessed as complying with the requirements of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations).