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Reclassification of hip, knee and shoulder joint replacements
Medical devices reforms
Total and partial hip, knee or shoulder joint replacements were reclassified as Class III medical devices on 1 July 2012. This means:
- Increasing the premarket assessment of their safety, quality and performance
- Enhancing their identification and traceability by including them in the ARTG individually rather than grouping them together under a single ARTG entry
Industry was provided a three year transition period from 1 July 2012 to apply for their class IIb hip, knee and shoulder joint implants to be reclassified and entered in the ARTG as Class III medical devices. This transition period ended on 30 June 2015. From 1 July 2015 any total and partial hip, knee or shoulder joint replacements must apply for inclusion on the ARTG as a Class III medical device.
|1 July 2015||End of reclassification transition period|
|20 April 2015||A regulatory amendment was enacted to include definitions of hip, knee and shoulder joint replacement medical devices and related ancillary devices.|
|24 April 2014||
A regulatory amendment was enacted to extend both: