TGA Joint Replacements Refunds on Related Ancillary Devices

After the reclassification of hip, knee and shoulder joint replacement from Class IIb to Class III medical devices on 1 July 2012, there was a 3 year transition to complete the reclassification process. The reclassification in Australia was modelled on the reclassification of these implants in the EU as Class III implants.

During the Australian transition, it became apparent that there were differences in interpretation of the classification rules within the EU itself. And since many manufacturers rely on European certification to support market entry in Australia, it was agreed that clarification was needed on which medical devices are joint replacements and classified as Class III medical devices and which medical devices are ancillary devices to the joint replacements, and therefore Class IIb devices under the Australian regulations.

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. Definitions can be found at: https://www.tga.gov.au/book/definitions

The amendment of the Regulations means that some ancillary devices to joint replacements could have been reclassified incorrectly as a Class III medical device during the transition period. These devices will need to be included in the Register as Class IIb medical devices instead. The TGA will provide a refund on application fees and annual charges.

For any regulatory enquiries regarding medical devices and IVDs contact KD&A on +61 4 11 101 392 or email us at kdent@kdas.com.au.