TGA Clarifies Evidence Needed for Joint Replacement Reclassification

Australia's Therapeutic Goods Administration (TGA) has issued guidance regarding the types of evidence that must be submitted by companies to meet the conformity assessment requirements for the reclassification of hip, knee and shoulder joint replacement implants.

The products are being changed from Class IIb designations, typically used for moderate-risk devices with special controls, to a Class III designation, which is typically given to high-risk medical devices.  

In addition to the TGA's own conformity assessment certificate, TGA said it will accept a European Commission certificate issued under the Medical Device Directive (MDD) or certificate of conformity issued under the Mutual Recognition Agreement (MRA) between the European Union and Australia.  The certification is acceptable either as a Full Quality Assurance procedure or Type Examination procedure and Production Quality Assurance procedure. 

A manufacturer's Declaration of Conformity is also required.