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

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。

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.