[医疗器械动物研究的监管考量]
[Regulatory Consideration for Animal Study of Medical Device].
作者信息
Cheng Maobo, Liu Wenbo, Zhang Jiazhen
机构信息
Center for Medical Device Evaluation, NMPA, Beijing, 100081.
出版信息
Zhongguo Yi Liao Qi Xie Za Zhi. 2023 Jul 30;47(4):428-432. doi: 10.3969/j.issn.1671-7104.2023.04.014.
Abstract
Animal study plays a key role to evaluate the safety and effectivity of medical devices. This study aims to share evaluated consideration on the role, general principles, necessity, study design and quality management system of animal study, in order to improve the quality of animal study and reduce unnecessary study.
摘要
动物研究在评估医疗器械的安全性和有效性方面发挥着关键作用。本研究旨在分享对动物研究的作用、一般原则、必要性、研究设计和质量管理体系的评估考量，以提高动物研究的质量并减少不必要的研究。
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