2018-2019年有源医疗器械国家抽检情况分析  

Analysis of National Sampling Inspection of Active Medical Devices in 2018-2019

作　　者：郝擎[1] 徐进 田佳 李晓[1] 张欣涛[1] Hao Qing;Xu Jin;Tian Jia;Li Xiao;Zhang Xintao(National Institutes for Food and Drug Control,Beijing 102600,China;Shanghai Testing and Inspection Institute for Medical Devices,Shanghai 201318,China;Shandong Quality Inspection Center For Medical Devices,Jinan 250101,China)

机构地区：[1]中国食品药品检定研究院,北京102600 [2]上海市医疗器械检测所,上海201318 [3]山东省医疗器械产品质量检验中心,济南250101

出　　处：《中国药事》2020年第12期1401-1407,共7页Chinese Pharmaceutical Affairs

摘　　要：目的:分析我国有源医疗器械抽检不合格品种的主要情况和原因,为生产企业加强生产体系管理、提升产品质量提供参考。方法:总结2018-2019年国家医疗器械抽检中有源医疗器械产品质量状况,分析主要不合格产品、项目,归纳不合格成因,提出改进建议。结果与结论:我国有源医疗器械不合格检出率总体稳定,不合格成因主要集中在可能变更产品设计或生产工艺、注册与生产脱节导致质量管理体系失效、采购验收和检验放行能力不足、标识和随机文件管理不善等。建议有源医疗器械生产企业从重视设计变更和工艺变更的验证、提高质量管理体系的约束力、建立并提升检验能力、加强标识和随机文件管理、重视与监管部门和检验机构的沟通等方面改进提升。同时,也建议药品监管部门持续做好不合格产品处置,制定出台有源医疗器械现场检查有关规范要求,进一步加强监督检查和飞行检查。Objective: To analyze the main situation and causes of disqualification of active medical devices in China, so as to provide references for enterprises to strengthen production system management and improve product quality. Methods: The quality status of active medical devices in the national sampling inspection of medical devices in 2018-2019 was summarized, the main unqualified products and items were analyzed, the causes of disqualification were summarized, and suggestions for improvement were put forward. Results and Conclusion: The unqualified detection rate of active medical devices in China was generally stable. The causes of disqualification mainly focused on the possible change of product design or production process, the failure of quality management system is caused by the disconnection between registration and production, insufficient purchasing acceptance and inspection release capacity, poor management of identification and random documents, etc. It is suggested that active medical device manufacturers should attach importance to the verification of design changes and process changes, improve the binding force of the quality management system, establish and enhance the inspection ability, strengthen the management of identification and random documents, and emphasize the communication with regulatory authorities and inspection institutions. It is also suggested that the drug regulatory authorities should continue to deal with the disposing of unqualified products, formulate and promulgate relevant specifications and requirements for on-site inspection of active medical devices, and further strengthen daily inspection and flight inspection.

关 键 词：有源医疗器械 抽检 质量管理体系 设计变更 生产工艺 出厂检验 

分 类 号：R95[医药卫生—药学] F203[经济管理—国民经济]