Present Situation and Thinking on the Reform of the Classifi cation and Regulation of Medical Devices in China

VernacularTitle:我国医疗器械分类监管改革的现状及思考
Author: Shifu GUO ¹ ; Ying HUANG ; Ruihong MU ; Jingli LI
Author Information

1. 国家食品药品监督管理总局医疗器械标准管理中心中国食品药品检定研究院
Keywords: medical device; classifi cation; reform
From: Chinese Journal of Medical Instrumentation 2016;40(5):355-358
CountryChina
Language:Chinese
Abstract: This paper introduces the domestic device regulatory classifi cation. Risk factors of medical equipment are analyzed. Combined with the analysis of the present situation of medical device regulatory classifi cation in china, this paper puts forward advice to reform and improve China's medical device regulatory classifi cation system.