Australia Releases New Joint Replacement Reclassification Guidance
Posted 20 March 2013 | By
Australia's Therapeutic Goods Administration (TGA) has posted new guidance reclassifying joint replacements such as hip, knee and shoulder replacement devices.
Under the new guidance, applications to reclassify a joint replacement implant from Class IIb (medium-high risk medical devices) to Class III (high-risk medical devices) could require more than one application. A single Class IIb joint implant may have to be 'cloned' into multiple reclassification applications if:
- a manufacturer developed a new device of the same kind, such as with the same Unique Product Identifier (UPI), but in a different size or other allowable variant
- the modification makes a different kind of device (different UPI)
Supporting information from the manufacturer, such as the design examination certificate and product information, may help distinguish whether the transitioning joint replacement implant is a different kind of medical device.
All hip, knee and shoulder joint implants were reclassified as high-risk devices in August 2012. A two-year transition period was provided for companies to complete conformity assessment procedures (Design Examination) to ensure that their implants meet the requirements for Class III medical devices before submitting reclassification applications.