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

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.