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 Online:2024-09-15 Published: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.

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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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