2017-2018年国家医疗器械抽检产品质量状况分析  

On Quality Status of National Sampling Inspection of Medical Devices from2017 to 2018

作　　者：郝擎[1] 张欣涛[1] 李晓[1] 石现[1] 朱炯[1] 朱宁 Hao Qing;Zhang Xintao;Li Xiao;Shi Xian;Zhu Jiong;Zhu Ning(National Institutes for Food and Drug Control, Beijing 102600, China;National Medical Products Administration, Beijing 100053, China)

机构地区：[1]中国食品药品检定研究院,北京102600 [2]国家药品监督管理局,北京100053

出　　处：《中国药事》2019年第7期790-795,共6页Chinese Pharmaceutical Affairs

摘　　要：目的:从国家医疗器械抽检结果出发,总结抽检品种质量状况特点,探讨如何进一步加强医疗器械监督管理。方法:通过对监督抽检发现的医疗器械质量状况存在的问题进行分析研究,提出相应的措施和意见建议。结果:有源医疗器械不合格检出率较高,无源医疗器械的原料选购和工艺存在一定问题,医疗器械领域贯彻执行国家标准、行业标准存在隐忧及一些问题企业。结论:应从落实企业主体责任并强化质量体系建设、严格处理问题产品和企业、提高审核查验针对性和力度、加大审评指导、加强国家标准和行业标准宣贯等角度入手,加强医疗器械监管。Objective: To summarize the quality characteristics of the samples and explore how to further strengthen the supervision and management of medical devices according to the results of the national sampling inspection of medical devices. Methods: The problems of the quality of medical devices discovered in the sampling inspection were analyzed and corresponding measures and suggestions were put forward. Results: The disqualification rate of active medical devices was relatively high. There were some problems in the raw material purchasing and technology of passive medical devices. There were some hidden concerns in the implementation of national and industrial standards and some problematic enterprises. Conclusion: It is suggested that the supervision and management of medical devices should be strengthened in the following aspects: implementing the main responsibility of enterprises and strengthening the construction of quality system, strictly dealing with problematic products and enterprises, improving the pertinence and intensity of the inspection, strengthening the guidance of evaluation, strengthening the publicity and consistency of national or industry standards, and so on.

关 键 词：医疗器械 抽检 质量状况 

分 类 号：R95[医药卫生—药学]