国家人工关节置换登记系统在医疗器械上市后监测中的作用与思考

doi:10.19803/j.1672-8629.20250142

摘要/Abstract

摘要： 目的探讨国家人工关节置换登记系统在医疗器械上市后主动监测中的作用,为我国建立相关系统提供参考。方法通过查阅国内外相关文献,分析全球范围内国家人工关节置换登记系统的发展现状、功能特点及实际应用案例,结合我国医疗器械监管需求,评估该系统在植入物安全性监测中的应用价值。结果与结论 国家人工关节置换登记系统作为医疗器械上市后主动监测的有效手段,已在许多国家成功实施,有助于早期识别与控制植入物相关风险。建议我国尽快建立国家人工关节置换登记系统,完善医疗器械全生命周期监管体系,提升植入物安全监测能力。

关键词: 植入物, 人工关节置换, 医疗器械, 登记, 系统, 上市后监测, 真实世界数据

Abstract: Objective To explore the role and significance of national arthroplasty registries in the post-market active surveillance of medical devices in order to provide a reference for establishing such a system in China. Methods By reviewing related literature, the developments, characteristics, and cases of applications of national arthroplasty registries worldwide were analyzed. Based on the need for regulation of medical devices in China, the applicability of these registries in surveillance of implant safety was evaluated. Results and Conclusion As an effective tool for post-market active surveillance of medical devices, national arthroplasty registries have been successfully implemented in many countries, which can facilitate early identification and control of implant-related risks. It is recommended that China quicken the establishment of a national arthroplasty registry, improve the system for regulation of whole lifecycle of medical devices and enhance the ability to monitor the safety of implants.

Key words: Implant, Arthroplasty, Medical Device, Registry, System, Post-Market Surveillance, Real-World Data

中图分类号:

R951
R994.11

李栋, 赵燕. 国家人工关节置换登记系统在医疗器械上市后监测中的作用与思考[J]. 中国药物警戒, 2025, 22(6): 640-644.

LI Dong, ZHAO Yan. Roles of National Arthroplasty Registries in Post-Market Surveillance of Medical Devices[J]. Chinese Journal of Pharmacovigilance, 2025, 22(6): 640-644.

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https://zgywjj.magtechjournal.com/CN/Y2025/V22/I6/640

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