进口医疗器械代理人管理制度研究

Research on the Management System for China Agent of Imported Medical Device

目的:对完善进口医疗器械代理人管理制度进行研究。方法:对进口医疗器械代理人的现状采用问卷调查的方式进行摸底,研究进口医疗器械代理人构成、能力、资质等现状,梳理分析进口医疗器械代理人制度运行中的主要问题。结论:目前进口医疗器械通关情形复杂,进口代理人无法掌握全部进口医疗器械信息;进口医疗器械相关主体权利义务不匹配;进口医疗器械代理人监管存在信息不对称。因此,笔者团队建议明确代理人法律责任边界,明确代理人条件和能力,设定规范使代理人可掌握进口产品信息,继续制修订代理人相关管理制度。

Objective:To improvie the management system for China agent of imported medical device.Methods:The current situation of China agent of imported medical device was investigated by means of questionnaires and so on;the composition,ability and qualification of China agent of imported medical device were studied;and the main problems in the implementation of system for China agent of imported medical device were analyzed.Conclusions:At present,the customs clearance of imported medical devices is complicated,and China agent cannot grasp all the information of imported medical devices;the rights and obligations of the relevant subjects of imported medical devices do not match;and there is an information asymmetry in the supervision on China agent of imported medical device.It is recommended to clarify the legal responsibility of China agent as well as their qualifications and capabilities,set regulations to make them to grasp the information of imported products,and continue to develop and revise the relevant system for them.