Hip, Knee and Shoulder Joint Reclassification – TGA Announce Regulation Changes
From July 1 2012, hip, knee and shoulder joint implants will be classified as Class III medical devices according to the Therapeutic Goods (Medical Device) Regulations 2002. The change comes after the Therapeutic Goods Administration (TGA) consultation paper, Reforms in Medical Devices Regulatory Framework, was released in late 2010. Australia is not the only country to make such changes, a number of overseas countries have reclassified these products in an aim to improve safety and quality for patients.
Devices affected by the change include total and partial implantable hip, knee and shoulder joints, including those devices already listed on the ARTG. The reclassification does not capture other implantable components or accessories such as screws or pins.
The change means that all hip, knee and shoulder joints must have an individual ARTG inclusion and can no longer be included as ‘kinds of devices’ (where one ARTG inclusion covers a group of devices).
New hip, knee and shoulder joints not currently on the Australian market
For those devices that do not have an ARTG number, the new classification ruling applies; which means the sponsor must complete a new Class III device application and level 2 audit are required prior to placing the product on the Australian market.
Hip, knee and shoulder joints already listed on the ARTG and available on the Australian market
For devices already on the ARTG (devices with an ARTG inclusion), a transitional period applies (until 2014). Prior to 1 July 2014 all devices must have undergone a reclassification application to obtain a Class III ARTG inclusion. This will involve a device assessment for individual devices during which the TGA will request and review the current manufacturer’s evidence for the device, a copy of the Australian Declaration of Conformity, the Design Examination Certificate, product information and materials, and post market information. The review is not a full level 2 audit (which is required for a new Class III device application), however the TGA can choose to complete this process should it be defined as appropriate for a particular device.
Importantly, the TGA have announced financial benefits for Sponsors who complete the transition sooner. Review fees are waived for the full transition period as well as device application fees for the 2012-2013 period (usually $1150 per device). In addition, annual fees are to remain at Class IIb level for the transition period ($890). Completing the required applications at the beginning of the transition period also reduces the likelihood of long processing times due to back logs, which could potentially result in a failure to comply with the transition period deadline.
Sponsors who do not complete the reclassification process
The TGA will advise sponsor of the intention to cancel all Class IIb hip, knee or shoulder joint replacement entries remaining on the ARTG as at June 30 2014. Should a re-classification application not be completed, the IIb ARTG inclusion will be cancelled (meaning the device cannot be sold on the Australian market).
Where to now…
KD&A can assist Sponsors to 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.