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.
作者
李晓
张欣涛
郝擎
朱炯
马金竹
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)
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
关键词
医疗器械
抽查检验
质量变化
medical device
supervision and inspection
quality variation