July 18, 2013

Hip, Knee and Shoulder Joint Reclassification: Only 12 Months Remain

The TGA are working towards the deadline of 30 July 2014 to finalise the reclassification of total or partial hip, knee and should joints. In another step towards this deadline, the reclassification application fee waiver in place has ceased. Sponsors applying for reclassification will now pay the application fee for a Class III device (currently AUD$1180) to the TGA.

As described in our news story dated September 2012, reclassification applies to a number of products. The GMDN codes used to describe devices on the Australian Register for Therapeutic Goods (ARTG) listed below are considered to be affected by the reclassification requirements.

32831 33581 33719 34198 36315 47514 48094
32832 33664 33745 34199 38155 48055 48095
32833 33665 33746 34203 38156 48056 55833
32835 33667 33863 34204 38519 48065 55834
32836 33668 33989 34209 39702 48066 56710
32841 33692 34003 34223 40125 48067 58085
33074 33694 34032 35661 41522 48068 58227
33175 33695 34038 35666 41557 48069 58228
33177 33704 34076 35667 43167 48070 58950
33178 33710 34162 35668 43168 48088 58951
33179 33711 34190 35669 44267 48089 90005
33180 33712 34191 35670 44362 48090
33181 33714 34192 35679 44855 48091
33369 33715 34195 36135 46326 48092
33580 33717 34197 36259 46585 48093

The TGA are urging those affected to complete applications for reclassification as soon as possible to avoid a back-log resulting in slow progress leading up to the July 2014 deadline. The transition period (of which there is 12 months remaining) allows Sponsors to avoid the mandatory application audit which will be applied (attracting a TGA fee of AUD$6350) once the reclassification implementation is complete, and list their product as a Class III as required.

Any Class IIb listings remaining on the ARTG under the GMDN codes listed above will be deleted after the July 2014 deadline.

Where to now...

KD&A can assist Sponsors to either implement processes to work towards reclassification or carry out the process of identifying, reviewing and completing up-classification applications including ensuring all variants of devices have suitable listings and reviewing supporting documentation prior to submission to the TGA. Contact us today for a personalised quotation.