关键词: 一次性使用血液透析器, 注册监管

Abstract: 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.

Key words: Hemodialysis devices, Registration supervision