医疗器械临床前动物试验研究的考虑要点  

Essential Considerations on Preclinical Animal Study for Medical Devices

作　　者：李天任 邵安良[1] 魏利娜[1] 陈亮[1] 徐丽明[1] Li Tianren;Shao Anliang;Wei Lina;Chen Liang;Xu Liming(National Institutes for Food and Drug Control, Beijing 102629, China)

机构地区：[1]中国食品药品检定研究院

出　　处：《中国药事》2019年第10期1121-1128,共8页Chinese Pharmaceutical Affairs

基　　金：科技重点研发计划(编号2016YFC1103200，编号2016YFC1103203)

摘　　要：目的:医疗器械安全性和有效性评价中动物试验是重要手段之一,医疗器械临床前动物试验研究是许多Ⅲ类医疗器械,特别是创新型医疗器械进行临床试验研究之前需要开展的重要项目。本综述为规范开展医疗器械临床前动物试验研究提供参考。方法:本文在归纳国内外医疗器械临床前动物试验研究领域的法规、标准的基础上,参考了《药物非临床研究质量管理规范》的框架对医疗器械临床前动物试验研究的考虑要点进行了归纳整理。结果:本文从人员、设施、仪器设备和实验材料、试验系统、标准操作规程、研究工作的实施、总结报告以及质量保证和资料档案等几个方面,归纳总结了医疗器械临床前动物试验研究的考虑要点。结论:本文为医疗器械临床前动物试验研究提供更全面的理解,为开展动物试验研究提供参考。Objective: Animal study is one of the important strategies for evaluating the safety and efficacy of medical devices. Preclinical animal study for many class Ⅲ medical devices, especially those innovative ones, is critical item before clinical studies. This review is to provide references and support for preclinical animal study for medical devices. Methods: Based on domestic and international laws, regulations and standards for preclinical study of medical devices, the essential considerations on preclinical animal studies were summarized. Results: The essential considerations on the animal study for medical devices were summarized from the following aspects, such as personnel, facility, instrument and equipment, experimental materials, test system, standard operating procedures, implementation of the studies, summary report, quality assurance, as well as documents and archives according to Good Laboratory Practice. Conclusion: This paper provides a more comprehensive understanding for the pre-clinical animal study of medical devices and provide references for conducting animal studies.

关 键 词：医疗器械 临床前动物试验研究 规范 标准 考虑要点 

分 类 号：R-332[医药卫生] R955