Joint replacement manufacturers: are you entitled to a regulatory refund in Australia?
This article was originally published in Clinica
Executive Summary
Australia’s Therapeutic Goods Administration is offering refunds* to manufacturers of hip, knee and shoulder implants and related ancillary devices, whose products may have been incorrectly classified as high-risk devices (Class III) instead of medium high-risk devices (Class IIb) because of what is now perceived as shortfalls in the Australian regulations.