医疗器械注册相关法规文件浅析

In Brief Analysis of Several Questions in the Process of Medical Device Registration

为了进一步规范医疗器械注册管理工作,国家食品药品监督管理局(以下简称国家局)近年来相继下发了一系列医疗器械注册法规文件。正确理解既有法规文件、后续发布的注册文件以及相互之间的关系,对于医疗器械生产企业和注册代理机构来说非常重要,有利于生产企业和注册代理机构准确提供相关注册材料、顺利通过注册。因此,本文对于注册中遇到的若干普遍问题提出一些理解,以供相关人员参考。

In order to enhance the management of Medical Device Registration,State Food and Drug Administration（SFDA） has issued a series of documents about the Medical Devices Registration in the recent years.It is very important for the manufactures and agent organizations to comprehend the documents properly.Therefore,this paper states some general questions in the Process of Medical Device Registration,provides some reference viewpoints for the manufactures and agent organizations.