首页|2023年中美医疗器械指导原则研究分析

2023年中美医疗器械指导原则研究分析

The Research and Analysis of the Medical Device Guiding Principles Between China and the United States in 2023

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文章旨在从数量和关注的热点两个方面,对2023年中国和美国发布的医疗器械指导原则进行比较分析,以揭示两国之间的差异,并据此为我国指导原则的体系完善提供相关建议.
This article aims to conduct a comparative analysis of the medical device registration review guidance principles issued by China and the United States in 2023 from the perspectives of quantity and key focuses.The objective is to reveal the differences between the two countries and provide relevant suggestions for improving the system of guidance principles in China based on these differences.

medical devicesguidance principlessystem

高田、张世庆

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国家药品监督管理局医疗器械技术审评中心 (北京 100076)

医疗器械 指导原则 体系

2024

中国医疗器械信息
中国医疗器械行业协会

中国医疗器械信息

影响因子:0.375
ISSN:1006-6586
年,卷(期):2024.30(19)