摘要
脑积水分流器产品是脑积水患者长期甚至终身使用的医疗器械,且该产品种类较多,设计各有特点。本文对脑积水分流器产品的注册申报资料中的要点进行了概述,为产品的研发、生产及上市前注册提供技术参考。
hydrocephalus shunt is a long-term use or life-long use medical device for patients with hydrocephalus. This kind of device has quite a few types which are designed with different characteristics. This paper summarizes the key points of technical documents and provides the reference for the development, manufacture and premarket registration of hydrocephalus shunt.
出处
《中国医疗器械信息》
2016年第12期23-26,30,共5页
China Medical Device Information
关键词
脑积水分流器
脑积水
注册申报
审评
hydrocephalus shunt
hydrocephalus
registration
technical review
