医疗器械/医用材料动物实验研究

Animal Research in Medical Devices/Medical Materials

动物实验研究是医疗器械/医用材料临床前安全性有效性评估的重要手段,其独特性在于研究范围广,无通用方法,故而,在该类研究的设计和执行上,需要进行多方面考虑。该文通过介绍医疗器械/医用材料动物实验研究的背景及法规,方案设计的参考原则及考虑因素,结果分析要点,实验期间的质量保证等内容,以期望为行业内研究人员提供参考。

Animal research of medical devices/medical materials is an essential part of preclinical safety and efficacy evaluation. Many questions should be taken in considerations when it comes to design and conduction animal research of medical devices/medical materials because of its uniqueness. This kind of research has widespread studying objects while has no universal standard method, and should be designed case-by-case. This article is aimed at serving as a reference for sponsors and researchers when performing preclinical safety and efficacy evaluation of medical devices/ medical materials.