Continuing Medical Education

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

  • Jiaying GUO ,
  • Zijing ZHOU ,
  • Yaohua LI
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  • Yangtze River Delta Center for Medical Device Evaluation and Inspection of NMPA, Shanghai 201210, China

Received date: 2024-04-02

  Online published: 2024-09-04

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.

Cite this article

Jiaying GUO , Zijing ZHOU , Yaohua LI . 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 . DOI: 10.12372/jcp.2024.24e0288

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