Joint reclassification advice: Transition timeframe extended to June 2015
On 24 April 2014, a regulatory amendment was enacted to extend the transition period by one year to 30 June 2015 for the reclassification of partial and total hip, knee and shoulder joint replacements.
Transitional provisions will continue to apply. There will be no annual charges applied for transitioned Class III joint implants until after 30 June 2015, and reclassification applications submitted by 30 June 2015 are not subject to mandatory audit requirements or related audit fees (reclassification applications may be selected for discretionary audit, for which no fees apply).
This timeframe extension was prompted by:
- the need for clarification about the range of medical devices that are hip, knee or shoulder joint replacement implants versus those that are intended to be solely used to assist the joint replacement on implantation, and providing additional stability and fixation; and
- the on-going availability for revision procedures of devices (or parts of devices) not transitioned, following the cancellation of these products from the Australian Register of Therapeutic Goods (ARTG) at the end of the transition.
This timeframe extension enables the TGA to undertake further consultation with affected stakeholders to consider the range of medical devices affected by reclassification, as well as options around the supply of devices for revision surgeries, without affecting the continuity of supply of devices to patients.
Sponsors should work towards the new 30 June 2015 transition deadline as now provided for in Part 11 of the Therapeutic Goods (Medical Device) Regulations 2002. Submission of applications for inclusion of these devices as Class III on the ARTG well in advance of the 30 June 2015 deadline is strongly advised. Any applications received after 30 June 2015 will not qualify for transitional arrangements, and will need to be submitted as a normal Class III application (including paying appropriate audit fees).
Class IIb inclusions for total or partial knee, hip or shoulder joint replacement devices will be cancelled on 1 July 2015 (except for any Class IIb devices for which there is a reclassification application pending at the end of the transition period, when the reclassification application is determined). Importing, exporting, supplying or manufacturing a medical device that is not included in the ARTG (unless exempted) may constitute criminal offence and/or civil penalty may apply.
The intention is to resolve questions about the appropriate classification of devices which are intended to assist the joint replacement on implantation by developing a more detailed definition of hip, knee or shoulder joint replacement implants. This will be the subject of consultation with stakeholders over the coming months.
The TGA is also examining issues arising where medical devices are not transitioned, but are required after that date for revision surgeries. These devices may still be supplied under the Therapeutic Goods Administration's Special Access Scheme arrangements if requested by the health practitioner. However, in the absence of an ARTG entry the device will not be eligible for reimbursement by private health insurers.