摘要
医疗器械生物学评价在保证医疗器械的安全性方面发挥着重要的作用。文章主要介绍了在技术审评中关注的医疗器械生物学评价的风险管理的内容,详细阐述了如何通过现有数据和信息的评价来支持医疗器械的生物学评价。
Biological evaluation of medical devices plays an important role in ensuring the safety of medical devices.This article mainly introduces the focus points of technical review about biological evaluation of management process within a risk of medical devices,and explains in detail how to support the biological evaluation of medical devices through the evaluation of existing data and information.
作者
田甜
TIAN Tian(Shanghai Food and Drug Administration Certification&Evaluation Center,Shanghai 200020)
出处
《中国医疗器械信息》
2020年第15期11-13,共3页
China Medical Device Information
关键词
医疗器械
生物学评价
风险管理
现有数据和信息
medical device
biological evaluation
risk management
existing data and information
