新法规体系下安徽省医疗器械技术审评工作现状调研  

Investigation and Survey on Status of Technological Evaluation Process of Medical Apparatus and Instruments in Anhui Province Under the New Laws and Regulations

作　　者：周冬 张弦 Zhou Dong;Zhang Xian(Anhui Center for Food and Drug Evaluation&Certification,Hefei,Anhui,China230051)

机构地区：[1]安徽省食品药品审评认证中心,安徽合肥230051

出　　处：《中国药业》2018年第5期76-79,共4页China Pharmaceuticals

摘　　要：目的探讨安徽省医疗器械产品注册现状、技术审评机构情况和存在问题,为加强和改进医疗器械产品技术审评工作提供合理化建议。方法对安徽省新法规实施后的第二类医疗器械产品技术审评办件资料的特征、时间分布、产品类型分布、产品类别分布、注册申报问题分布进行统计学分析。结果与结论省级技术审评机构应当通过强化集体讨论,完善技术审评制度,丰富审评员专业结构,加强对医疗器械企业的咨询服务,真正从源头上提升审评质量和效率,降低审评质量风险。Objective To investigate the status of medical apparatus and instruments registration,the situation of the technical evaluation institution and the existing problems,in order to provide reasonable suggestions for strengthening and improving the technical evaluation of medical apparatus and instruments in Anhui Province.Methods The characteristics,time distribution,product type,product category and registration declaration of the technological evaluation data of the class II medical apparatus and instruments were analyzed statistically after the implementation of new laws and regulations in Anhui Province.Results and Conclusion The provincial technical evaluation institution should improve quality and efficiency of the evaluation and reduce quality risk of the evaluation from the source by strengthening the collective discussion,perfecting the technical evaluation system,enriching the review professional structure and strengthening the consulting service of medical device companies.

关 键 词：医疗器械 技术审评 现状 建议 

分 类 号：R954[医药卫生—药学]