地方药监部门对医疗器械生产企业飞行检查的规范化研究  

Study on Normalization of Flight Inspection of Medical Instrument Manufacturers by Local Drug Administration

作　　者：陈褚建 吴林松 厉芬 CHEN Chu-jian;WU Lin-song;LI Fen(Huzhou Food and Drug Research Institute,Zhejiang Huzhou 313000;Huzhou Drug Certification Inspection Sub-bureau,Zhejiang Huzhou 313000)

机构地区：[1]湖州市食品药品检验研究院,浙江湖州313000 [2]湖州市药品认证检查分局,浙江湖州313000

出　　处：《中国医疗器械信息》2021年第17期16-17,41,共3页China Medical Device Information

摘　　要：近年来,医疗器械产品越来越丰富化、专业化,与此同时,医疗器械生产企业鱼龙混杂,这就需要当地药监部门采取有效的手段对相关医疗器械产品的质量进行更多的把控。飞行检查就是面对这种现象衍生出的一种非常行之有效的监管手段。虽然飞行检查已经有了较为成熟的手段和比较完善的体系,但对医疗器械的飞行检查其规范仍有不完善之处,有些流程和相关要求都无法严格按照标准去施行,需要对飞行检查的规范性和有效性进行进一步的研究。文章通过对医疗器械生产企业的飞行检查中不规范的问题进行汇总,根据地方药监部门对于医疗器械企业生产过程中存在的现实情况,探究相关飞行检查的规范性和规范化体系的建设的相关问题。In recent years,medical instrument products in society have become more and more diversified and specialized,and related medical instrument manufacturers have become a mixed bag as the number increases.This requires the local drug regulatory authorities to provide effective means to have more control over the quality of related medical instrument products.Flight inspection is a very effective regulatory method derived from this phenomenon.Although there are relatively mature means and complete systems for flight inspection,there are still imperfections in the regulations for flight inspection,of medical instrument.Some procedures and related requirements cannot be implemented in strict accordance with the standards.Further research on the standardization and effectiveness of flight inspection.This study explores the issues related to the standardization of flight inspection and the construction of a normalization system based on the actual situation in the production process of medical instrument enterprises by local drug regulatory authorities based on the irregularities in the flight inspection of medical instrument manufacturers.

关 键 词：医疗器械 飞行检查 规范化 

分 类 号：R197.39[医药卫生—卫生事业管理]