中国血液净化

中国血液净化 ›› 2019, Vol. 18 ›› Issue (08): 582-584.doi: 10.3969/j.issn.1671-4091.2019.08.019

• 血液净化中心管理 • 上一篇    下一篇

一次性使用胆红素血浆吸附器注册技术文件重点介绍

骆庆峰1,王永清1   

  1. 1. 国家药品监督管理总局医疗器械技术审评中心
  • 收稿日期:2019-04-04 修回日期:2019-05-13 出版日期:2019-08-12 发布日期:2019-08-15
  • 通讯作者: 骆庆峰 lqf0016017@126.com E-mail:lqf0016017@126.com

The important content of the technical documents for the registration of single-use bilirubin plasma adsorbers

  1. 1Center for Medical Device Evaluation, NMPA, Beijing 100081, China
  • Received:2019-04-04 Revised:2019-05-13 Online:2019-08-12 Published:2019-08-15

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摘要： 【摘要】近年来，我国日益重视血液净化疗法对肝炎等疾病的防治，一次性使用胆红素血浆吸附器的申报数量不断增多。为便于监管部门对其上市前的安全性、有效性进行准确评价，本文总结近期技术审评经验，参考相关法规、技术标准，编写了注册技术资料重点介绍，以供生产、技术审评等单位部门参考。

关键词: 胆红素血浆吸附器, 注册, 文件

Abstract: 【Abstract】In recent years, China has paid more and more attention to the treatment of diseases such as hepatitis by using blood purification technologies. The number of application for single-use bilirubin plasma adsorbers has been increasing. In order to facilitate the supervision department to accurately evaluate their safety and effectiveness before marketing, this paper summarizes the recent experiences of technical review, and refers to the relevant laws and technical standards to compile the important content of technical documents for registration, which may be useful references for production, technical review and other related units.

Key words: Bilirubin plasma adsorber, Registration, Document

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