浅析2020年国家医疗器械质量抽查检验品种质量变化特点  

Analysis on the Characteristics of Quality Variation of National Medical Device Supervision and Inspection in 2020

作　　者：李晓[1] 张欣涛[1] 郝擎[1] 朱炯[1] 马金竹[2] 杨国涓 LI Xiao;ZHANG Xintao;HAO Qing;ZHU Jiong;MA Jinzhu;YANG Guojuan(National Institutes for Food and Drug Control,Beijing,102629;Tianjin Medical Devices Quality Supervision and Testing Center,Tianjin,300384)

机构地区：[1]中国食品药品检定研究院,北京市102629 [2]天津市医疗器械质量监督检验中心,天津市300384

出　　处：《中国医疗器械杂志》2022年第3期326-331,共6页Chinese Journal of Medical Instrumentation

摘　　要：根据历年国家医疗器械质量抽查检验结果,通过横向对比分析,总结2020年国家医疗器械质量抽查检验品种质量变化特点。针对医疗器械生产及上市后监管措施提出建议,进一步提高医疗器械产品质量,保障公众用械安全。This study is based on the summary of the characteristics of quality variation of national medical device supervision and inspection in 2020. According to the results of the national medical device supervision and inspection through comparative analysis, this study puts forward suggestions on the medical device production and supervision measures for the post-marketing products, so as to further improve the level of the medical device and ensure the safety use of medical device.

关 键 词：医疗器械 抽查检验 质量变化 

分 类 号：R197.39[医药卫生—卫生事业管理]