1.
Chinese Journal of Medical Instrumentation
; (6): 202-205, 2018.
Article
in Chinese
| WPRIM
| ID: wpr-689832
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.