中国血液净化

中国血液净化 ›› 2023, Vol. 22 ›› Issue (05): 327-329.doi: 10.3969/j.issn.1671-4091.2023.05.002

• 管理 • 上一篇    下一篇

血液透析器技术审评要点简介

骆庆峰   肖 丽    杨宇希   蔡娜娜   

  1. 100081 北京，1国家药品监督管理局医疗器械技术审评中心
  • 收稿日期:2023-02-20 修回日期:2023-03-10 出版日期:2023-05-12 发布日期:2023-05-12
  • 通讯作者: 骆庆峰 E-mail:luoqf@cmde.org.cn

Brief introduction of technical review key points of hemodialyzer

LUO Qing-feng, XIAO Li, YANG Yu-xi, CAI Na-na   

  1. Center for Medical Device Evaluation, National Medical Products Administration, Beijing100081, China
  • Received:2023-02-20 Revised:2023-03-10 Online:2023-05-12 Published:2023-05-12
  • Contact: 100081 北京，1国家药品监督管理局医疗器械技术审评中心 E-mail:luoqf@cmde.org.cn

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摘要： 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。

关键词: 血液透析器, 技术审评, 有效性, 安全性

Abstract: 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 administration, technical requirements, process research, evaluation of toxic substances, Quality Control System, etc. according to the latest regulations, national/industrial standard terms, and the latest cognitive level. For the reference of professionals in research and development, production, review, supervision and other related fields.

Key words: Hemodialyzer, Technical review, Effectiveness, Security

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