PMD7 Analysis of Medical Device Recall Reports in China from a Regulatory Science Perspective: Implications for Post-Marketing Surveillance

Abstract

In China, medical device is an essential part of healthcare service and represents a fasting growing healthcare market. To safeguard patient safety and improve regulatory decision-making, the National Medical Products Administration (NMPA) has set to advance the post-marketing surveillance system and adopt regulatory science (RS) for capacity enhancement. However, little is known about the most recent concerns of medical devices in the sizeable marketplace. This research aimed to analyze the official medical device recall reports and to explore priority actions for advancing RS in medical device.