Balancing Innovation and the Safe Introduction of Orthopedic Arthroplasty Implants to Market: The Ever-Evolving Regulatory Environment in Australia.

Abstract

The safe introduction of orthopedic medical devices remains a global priority due to high-profile failures and evolving regulatory conditions. Recent reforms to regulatory requirements in Europe, the United States and Australia seek to strengthen both pre- and post-market medical device evaluation. This perspective review outlines the current Australian regulatory environment with comparison to the European and United States systems, where arthroplasty devices must comply with Essential Principl