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

Abstract

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

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.

References 21

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

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