健康发展与政策研究2025，Vol.28Issue(1)：89-97,9.DOI:10.12458/HDPR.202411088
2019-2024年我国医疗器械上市与召回风险分析及对策研究
Risk analysis and countermeasures for medical device approvals and recalls in China from 2019 to 2024
刘云鹏 1徐杨 2过其祥 2李泽宇 1杨悦2
作者信息
- 1. 海南大学生物医学工程学院,海南 海口 570228||清华大学药学院,国家药品监督管理局创新药物研究与评价重点实验室,北京 100084
- 2. 清华大学药学院,国家药品监督管理局创新药物研究与评价重点实验室,北京 100084
- 折叠
摘要
Abstract
Objective To analyze the trend of approvals and recalls of medical devices in China,and study the connection between the approval characteristics of medical devices and their recalls.Method Data were obtained from the official website of the National Medical Products Administration(NMPA)to analyze the approvals and recalls of medical devices in China from 2019 to 2024 in terms of the location of product manufacturing,product management category,product classification,recall level,and reasons for recall.Results The number of medical devices on the market in China is increasing.The innovativeness is improving,and the number of product recalls is decreasing year by year.During the study period,a total of 2,488 medical devices were recalled,75.1%of the recalled medical devices were imported ones and 50.4%were Class Ⅲ medical devices.Among recalls of domestic medical device,61.6%were initiated based on regulatory monitoring.The incidence of Class Ⅲ medical device approvals and recalls in China over the past 5 years is 1.8%.Class Ⅲ high-risk devices are significantly more likely to be subject to Class I recalls compared with Class Ⅰ and Ⅱ devices(P＜0.001).Currently,device design(58.1%),materials and manufacturing(28.4%)and software(6.1%)are the main reasons for Class Ⅰ recalls.Conclusions In view of the current situation and characteristics of medical device approvals and recalls in China,the main responsibility of enterprises should be strengthened,and domestic enterprises should be encouraged to enhance adverse event reporting and recall proactively.The monitoring of high-risk devices should be increased,and the risk prevention system constructed according to historical recall data could optimize the design and supervision of medical devices.关键词
医疗器械/医疗器械分类/产品召回/风险管理/上市后监管Key words
medical devices/medical device classification/product recalls/risk management/post-market surveillance分类
医药卫生引用本文复制引用
刘云鹏,徐杨,过其祥,李泽宇,杨悦..2019-2024年我国医疗器械上市与召回风险分析及对策研究[J].健康发展与政策研究,2025,28(1):89-97,9.
