Medical Device Registration Management
Medical device registration management is among the most critical links in full-lifecycle management, connecting R&D and production, judging safety and effectiveness, and underpinning post-market quality management. This work studies the system's development across periods since 1996, analyzes new practical issues and explores innovation paths.
Key changes: Class I devices shifted from registration to filing management, applying risk management concepts and improving regulatory efficiency; the 2014 regulation replaced re-registration with renewal registration; and the review, emergency and priority review mechanisms for innovative medical devices keep improving.