中美两国儿科用医疗器械监管现状及临床研究探讨

doi:10.12372/jcp.2024.24e0288

临床儿科杂志 ›› 2024, Vol. 42 ›› Issue (9): 822-826.doi: 10.12372/jcp.2024.24e0288

• 继续医学教育 • 上一篇

中美两国儿科用医疗器械监管现状及临床研究探讨

郭佳莹, 周滋晶, 李耀华()

国家药品监督管理局医疗器械技术审评检查长三角分中心（上海 201210）

收稿日期:2024-04-02 出版日期:2024-09-15 发布日期:2024-09-04
通讯作者: 李耀华电子信箱：liyh@ydcmdei.org.cn

Supervision status and clinical research of pediatric medical devices in China and the United States

GUO Jiaying, ZHOU Zijing, LI Yaohua()

Yangtze River Delta Center for Medical Device Evaluation and Inspection of NMPA, Shanghai 201210, China

Received:2024-04-02 Published:2024-09-15 Online:2024-09-04

摘要/Abstract

摘要：

儿科医疗器械的发展面临挑战，不能满足儿科临床需求，然而开展儿科人群医疗器械临床研究较为困难。本文介绍了国内儿科医疗器械的发展现状，国内和美国儿科医疗器械相关的法规指南，并探讨儿科人群医疗器械临床研究设计的注意事项，以期为相关临床研究的开展提供借鉴。

关键词: 医疗器械, 临床研究, 政策法规, 儿科人群

Abstract:

The development of pediatric medical devices faces challenges and cannot meet the clinical needs of pediatric patients, however, conducting clinical research on pediatric medical devices is difficult. This article explores the current development status of pediatric medical devices in China and discusses the relevant regulations and guidelines in both China and the United States. It also delves into the considerations for conducting clinical research in the pediatric population, aiming to provide reference for the implementation of related clinical studies.

Key words: medical device, clinical research, policy and regulation, pediatric population

郭佳莹, 周滋晶, 李耀华. 中美两国儿科用医疗器械监管现状及临床研究探讨[J]. 临床儿科杂志, 2024, 42(9): 822-826.

GUO Jiaying, ZHOU Zijing, LI Yaohua. Supervision status and clinical research of pediatric medical devices in China and the United States[J]. Journal of Clinical Pediatrics, 2024, 42(9): 822-826.

参考文献 21

[1]	刘露, 崔馨月, 张宇晶, 等. 成人数据外推至儿科人群探讨[J]. 中国医疗器械杂志, 2019, 43(5): 375-378.
[2]	沈晓明, 王卫平. 儿科学[M]. 第7版. 北京: 人民卫生出版社, 2008.
[3]	Food and Drug Administration. Premarket assessment of pediatric medical devices[EB/OL]. [2024-04-02]. https://www.fda.gov/media/73510/download.
[4]	程云, 张宏. FDA对儿科医疗器械的上市前评价[J]. 首都医药, 2010, 17(20): 8-9.
[5]	中华人民共和国国务院. 医疗器械监督管理条例[国令第739号][EB/OL]. [2024-06-07]. https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20210319202057136.html.
[6]	国家药品监督管理局. 医疗器械优先审批程序[EB/OL]. [2024-06-07]. https://www.cmde.org.cn//flfg/fgwj/ggtg/20220110111838158.html.
[7]	国家药品监督管理局. 用于罕见病防治医疗器械注册审查指导原则[EB/OL]. [2024-06-07]. https://www.cmde.org.cn//flfg/zdyz/zdyzwbk/20181026111100309.html.
[8]	国家药品监督管理局. 医疗器械附条件批准上市指导原则[EB/OL]. [2024-06-07]. https://www.cmde.org.cn//flfg/zdyz/zdyzwbk/20191227092950209.html.
[9]	国家药品监督管理局. 超声多普勒胎儿监护仪注册技术审查指导原则(2017年修订版) [EB/OL]. [2024-06-07]. https://www.cmde.org.cn//flfg/zdyz/zdyzwbk/20180206104300996.html.
[10]	国家药品监督管理局. 含儿科应用的医用诊断X射线设备注册审查指导原则(2021年第104号) [EB/OL]. [2024-06-07]. https://www.cmde.org.cn//flfg/zdyz/zdyzwbk/20211229091445786.html.
[11]	国家药品监督管理局. 新生儿蓝光治疗仪注册审查指导原则(2021年第104号) [EB/OL]. [2024-06-07]. https://www.cmde.org.cn//flfg/zdyz/zdyzwbk/20211229091652336.html.
[12]	Food and Drug Administration. Providing information about pediatric uses of medical devices[EB/OL]. [2024-06-07]. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-information-about-pediatric-uses-medical-devices.
[13]	Food and Drug Administration. Leveraging existing clinical data for extrapolation to pediatric uses of medical devices[EB/OL]. [2024-06-07]. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/leveraging-existing-clinical-data-extrapolation-pediatric-uses-medical-devices.
[14]	Food and Drug Administration. Ethical considerations for clinical investigations of medical products involving children[EB/OL]. [2024-06-07]. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ethical-considerations-clinical-investigations-medical-products-involving-children.
[15]	Food and Drug Administration. Considerations for long-term clinical neurodevelopmental safety studies in neonatal product development[EB/OL]. [2024-06-07]. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-long-term-clinical-neurodevelopmental-safety-studies-neonatal-product-development.
[16]	许淑红, 张绮, 张林琦, 等. 探讨我国儿科用药的发展现状及政策层面的思考[J]. 中国临床药理学杂志, 2020, 36(12): 1760-1767.
[17]	程金莲, 谭刚, 赵秀丽, 等. 儿科人群临床试验中对受试者疼痛管理的伦理考虑[J]. 药物评价研究, 2021, 44(6): 1201-1206.
[18]	国家药品监督管理局. 儿科人群药物临床试验技术指导原则[EB/OL]. [2024-06-07]. https://www.cde.org.cn/zdyz/domesticinfopage?zdyzIdCODE=e20e9bd309366a800d3b0cda9f2d9359.
[19]	王晓敏, 虢毅, 袁秀洪, 等. 儿科人群临床研究中"同意"的伦理探讨及对策[J]. 中国医学伦理学, 2018, 31(11): 1403-1407.
[20]	国家药品监督管理局. 真实世界数据用于医疗器械临床评价技术指导原则(试行)(2020年第77号)[EB/OL]. [2024-06-07]. https://www.cmde.org.cn//flfg/zdyz/zdyzwbk/20201126102802881.html.
[21]	国家药品监督管理局. 接受医疗器械境外临床试验数据技术指导原则[EB/OL]. [2024-06-07]. https://www.cmde.org.cn//flfg/zdyz/zdyzwbk/20180206135100162.html.

中美两国儿科用医疗器械监管现状及临床研究探讨

Supervision status and clinical research of pediatric medical devices in China and the United States

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