中国血液净化

中国血液净化 ›› 2025, Vol. 24 ›› Issue (04): 265-267.doi: 10.3969/j.issn.1671-4091.2025.04.001

• 管理 •    下一篇

血液净化用中心静脉导管注册常见问题分析

湛娜   

  1. 100081 北京，国家药品监督管理局医疗器械技术审评中心
  • 收稿日期:2024-07-19 修回日期:2025-01-17 出版日期:2025-04-12 发布日期:2025-04-12
  • 通讯作者: 湛娜 E-mail:kay20014098@sohu.com

Analysis of problems in registration of central venous catheters for blood purification

ZHAN Na   

  1. Center for Medical Device Evaluation，National Medical Products Administration, Beijing 100081, China
  • Received:2024-07-19 Revised:2025-01-17 Online:2025-04-12 Published:2025-04-12
  • 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:kay20014098@sohu.com

摘要： 血液净化用中心静脉导管与各类体外循环器械如血液透析器、血液灌流器等联合使用。本文从注册监管角度，对该产品的注册资料常见问题进行分析。

关键词: 血液净化, 中心静脉导管, 注册监管

Abstract: The central venous catheter for blood purification is often used in combination with various extracorporeal circulation devices, such as dialyzers and hemoperforates. This article analyzes common issues with the registration information of the product from the perspective of medical device registration and supervision.

Key words: Blood purification; , Central venous catheters, Registration and supervision

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