规范医疗器械网络在线信息管理

Discussion on Standard Management of Online Date of Medical Device

目的:结合医疗器械备案清理规范行动,探讨医疗器械在线信息查询、公布和管理。方法:检索国家药监局网站公布的医疗器械产品注册信息的现状,结合相关法规,分析其合规性。结果:网站已公布的产品型号规格、结构组成、预期用途等信息存在缺失、失真以及审批待规范的现象,不利于查询、应用和监管工作。结论:建议完善网络信息管理,加强信息发布的审批,规范注册管理。

Objective:To discuss the application statues of date searching for medical device by disentangle some of filed medical device,so as to strengthen the compliance management of online date.Methods:It was retrieved some of date published by NMPA network(www.nmpa.gov.cn)and was analyzed on compliance with registration.Results:It was found that some date was not easy access or distortion,and uncoordinated with registration requirement such as type specification,product structure,expected use and scope of application of published by the network.It was get out of order for registration of medical device.Conclusion:It is suggested to establish and update online control system and admittance in achieving compliance goal for registration.