血液透析器技术审评要点简介

Brief introduction of technical review key points of hemodialyzer

为保证血液透析器的有效性和安全性,本文依据最新法规,引用国家/行业标准条款,结合最新认知水平,从风险管理、技术要求、工艺研究、毒性物质评价、质量管理体系等方面,概述了血液透析器上市前技术审评关键内容。供研发、生产、审评、监管等相关领域专业人士参考使用。

In order to ensure the effectiveness and safety of the hemodialyzer,this paper summarizes the key contents of the pre-marketing technical review of the hemodialyzer from the aspects of risk administra-tion,technical requirements,process research,evaluation of toxic substances,Quality Control System,etc.ac-cording to the latest regulations,national/industrial standard terms,and the latest cognitive level.For the refer-ence of professionals in research and development,production,review,supervision and other related fields.