TGA Offers Checklist, Tips on Joint Class III Reclassification Submissions

In keeping with plans to reclassify hip, knee and shoulder joint implants from Class IIb to Class III, Australia’s Therapeutic Goods Administration (TGA) last month released a checklist of documents companies must submit to the agency. According to the Jan. 23 notice, reclassification application forms should include: current manufacturer’s evidence,
design examination or type examination certificate for the device, copy of conformity declaration, instructions for use (IFU), representative labeling for the device, manufacturers’ brochure and associated advertising material that illustrates product variants and
postmarket data from the National Joint Replacement Registry (NJRR).
International Medical Device Regulatory Monitor