IVD term development handover to GMDN Agency
During the transition period for implementation of the IVD regulatory framework in Australia, which commenced on 1 July 2010, the TGA assisted industry by ensuring that relevant preferred terms (PTs) and collective terms (CTs) were available in the GMDN database for their IVDs. During the four years of the transition period to 1 July 2014, the TGA assisted the GMDN Agency to create approximately 13,000 new PTs and 315 CTs covering most existing IVDs in use in Australia and worldwide. From 1 January 2015, the GMDN Agency will be responsible for creation of new PTs and CTs. Manufacturers who require new GMDN term(s) for their IVDs will need to apply to the GMDN Agency for membership through the website. Annual membership fees for manufacturers, and any additional charges for creation of new GMDN codes, vary according to company sales turnover - see Schedule B on the GMDN Agency website.
The TGA will continue to provide technical advice to the GMDN Agency but will not be responsible for arranging the development of new GMDN terms for manufacturers or sponsors from 1 January 2015.