Analysis of Changes in Medical Device Classification Concept of the New EU Regulations.

Author: Chunqing ZHANG ¹ ; Liangbin ZHOU ² ; Yue WANG ¹ ; Li YI ¹ ; Wanjuan YANG ¹ ; Shankui RONG ¹ ; Jingli LI ¹
Author Information

1. National Institute for Food Drug Control, Beijing, 100050. ##Email#.
2. Guangdong Medical Devices Quality Surveillance and Test Institute, Guangzhou, 510663. ##Email#.
Publication Type:Journal Article
Keywords: classification management; medical devices; regulation; the European Union
MeSH: Equipment and Supplies; classification; European Union; Government Regulation; Industry
From: Chinese Journal of Medical Instrumentation 2018;42(3):202-205
CountryChina
Language:Chinese
Abstract: By comparing new medical device regulations with existing directives in the European Union, the revising ideas of new EU medical device regulations, especially the changes of the classification management concepts, were analyzed to provide clues for the industry to interpret the new EU regulations, and references for the classification management innovation in our country.