关键词: 患者登记, 医疗器械, 监管科学, 主动监测, 真实世界数据

Abstract: Objective To explore the feasibility and significance of active monitoring of patient registries in the light of actual supervision of medical devices in China, and to propose the incorporation of patient registries into regulatory science as a new method of monitoring. Methods Based on literature review, cases of patient registry research that had been carried out at home and abroad were analyzed and the application of patient registries as a proactive monitoring method in regulatory decision-making for high-risk implantable medical devices was elaborated. Results As an important real-world data source, patient registries have become a useful means and method to gather “real-world” evidence on high-risk implantable medical devices and provide critical evidence for national regulatory decisions. Conclusion In order to become aligned with the characteristics of the medical device industry and trends of globalization, it is recommended that patient registries be incorporated into the science of medical device supervision in China as a new tool for proactive monitoring.

Key words: patient registries, medical device, regulatory science, proactive monitoring, real-world data