一次性使用血液透析器注册常见问题分析

Common problems in supervision of the hemodialysis devices for single-use

一次性使用血液透析器采用弥散、超滤和对流原理清除血液中有害物质和过多的水分,在肾脏替代治疗中发挥着至关重要的作用。血液透析器也可用于药物过量和毒物中毒等的辅助治疗。由于目前注册申报资料缺陷较多,本文试图从医疗器械注册监管角度对血液透析器常见注册问题进行简要分析。

Hemodialysis devices for single use are used to remove harmful substances and excessive water in blood by diffusion,ultrafiltration and convection,playing a key role in renal replacement therapy.It can also be used in the adjunct treatment for patients with drug overdose and toxicosis.However,some problems and defects exist in the documents recently submitted to the Center for Medical Device Evaluation for registration.This article attempts to make a brief analysis on these problems from the perspective of registration and supervision of the medical devices.