浙江省医疗器械委托生产跨区域监管实践

Cross-Regional Supervision Practice of Medical Device Commissioned Production in Zhejiang Province

新修订的《医疗器械监督管理条例》巩固和深化了医疗器械审评审批制度改革成果,全面建立了医疗器械注册人制度。医疗器械注册人制度在有利于鼓励产品创新、优化资源配置的同时,使医疗器械生产组织形式更加多样,特别是医疗器械注册人跨区域开展委托生产,给医疗器械监管工作带来了挑战。本文梳理浙江省医疗器械跨区域委托生产基本情况和规律性特点,分析注册人及备案人质量管理体系运行情况,总结跨区域协同监管举措和成效,以期为全国医疗器械跨区域委托生产监管提供实践经验。

The newly revised Regulations on the Supervision and Administration of Medical Devices consolidates and deepens the achievements of the reform of the medical device review and approval system,comprehensively establishing the medical device marketing authorization holder(MAH)system.While the medical device MAH system encourages product innovation and optimizes resource allocation,it also diversifies medical device production organization,especially in cases of medical device MAH conducting cross-regional commissioned production,which poses challenges to medical device supervision.This paper reviews the basic situation and regular patterns of cross-regional commissioned production of medical devices in Zhejiang Province,analyzes the operation of the quality management system of MAH,and summarizes measures and outcomes of cross-regional collaborative supervision.This work aims to provide practical experience for the cross-regional commissioned production supervision of medical devices in China.