Joint replacement definition - regulatory amendment
The Therapeutic Goods (Medical Devices) Regulations 2002 have been amended to include definitions of hip, knee and shoulder joint replacement medical devices and related ancillary devices.
Why make this change?
Hip, knee and shoulder joint implants (total and partial) were reclassified from Class llb (medium-high risk medical devices) to Class lll (high risk medical devices) on 1 July 2012. As part of this change a transition period was provided for sponsors of existing Class IIb ARTG entries for affected medical devices to apply for reclassification.
As the reclassification transition period progressed it became apparent that there were differences in interpretation of the classification rules within the Europe Union. Many manufacturers reply on European certification to support market entry in Australia. Given this it was agreed greater clarity was needed on which medical devices are joint replacements and so classified as Class lll medical devices under Australian regulations, and which devices act as ancillary devices to the joint replacement and are Class llb medical devices.
The new definitions
To provide greater clarity definitions have been developed in consultation with industry and representatives of key health professional bodies to clarify what is meant by a total or partial shoulder, hip or knee joint replacement, an ancillary device, and the hip, knee and shoulder joints.
Definitions have been included in the dictionary of the Therapeutic Goods (Medical Devices) Regulations 2002 for:
- Joint replacement medical device
- Ancillary medical device
- Hip, knee and shoulder joints
Guidance for sponsors and manufacturers
More detailed guidance on this change has been prepared for affected manufacturers and sponsors. It explains how the various parts of the definitions operate in practice, including examples of how kinds of devices are classified.
The clarifying definitions may mean some devices already included as Class III devices on the ARTG should be included as Class IIb medical devices. The amendments include provision to refund application fees and annual charges in this situation.