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.
维普
万方数据