湖南省医疗器械生产企业管理体系分析  

Analysis of Management System for Medical Device Manufacturers in Hunan Province

作　　者：喻亮宇 刘园园 扈麟 谭杰琼 姚蓉 YU Liangyu;LIU Yuanyuan;HU Lin;TAN Jieqiong;YAO Rong(Hunan Drug Inspection Center,Changsha,Hunan,China 410001;Hunan Institute for Drug Control,Changsha,Hunan,China 410001;Hunan Food and Drug Vocational College,Changsha,Hunan,China 410001)

机构地区：[1]湖南省药品审核查验中心,湖南长沙410001 [2]湖南省药品检验检测研究院,湖南长沙410001 [3]湖南食品药品职业学院,湖南长沙410001

出　　处：《中国药业》2024年第22期41-43,共3页China Pharmaceuticals

摘　　要：目的为完善医疗器械生产企业监管体系提供参考。方法总结2023年湖南省医疗器械注册人及生产企业监督检查情况,评估现阶段省内企业质量管理水平,分析检查过程中发现的主要问题及原因,提出思考和建议。结果对586家次医疗器械注册人及生产企业开展监督检查,共发现缺陷1343项(一般缺陷1141项,严重缺陷202项),主要集中在文件管理、质量控制、厂房与设施3个方面。结论建议监管部门应提前摸底,避免无效检查;明确检查重点,提高检查效率;医疗器械注册人及生产企业提升责任意识和质量管理、风险防控、识错纠错的能力;并需加强人员综合素质的培养。Objective To provide a reference for improving the supervision system of medical device manufacturers.Methods The information on the supervision and inspection of medical device registrants and manufacturers in Hunan Province in 2023 was summarized,the current quality management of enterprises in the province was evaluated,the main problems and reasons found during the inspection were analyzed,the relevant thoughts and suggestions were proposed.Results A total of 586 medical device registrants and manufacturers were supervised and inspected,and 13~43 defects(1141 general defects and 202 serious defects)were found,mainly focused on document management,quality control,factory and facility.Conclusion It is recommended that regulatory departments should make a thorough investigation in advance to avoid ineffective inspections,clarify inspection priorities,and increase inspection efficiency;medical device registrants and manufacturers should enhance their sense of responsibility,improve the abilities to manage quality,prevent and control risks,identify and correct errors;both regulatory departments and manufacturers should strengthen the cultivation of personnel′s comprehensive quality.

关 键 词：湖南省 医疗器械 注册人 生产企业 质量管理 监管 

分 类 号：R95[医药卫生—药学]