Changes and Related Reflections on the European Union's in Vitro Diagnostic Medical Device Classification Supervision System.
10.3969/j.issn.1671-7104.2021.06.017
- Author:
Liangbin ZHOU
1
;
Le CUI
2
;
Juan CHENG
1
;
Ying HUANG
2
Author Information
1. Guangdong Medical Devices Quality Surveillance and Test Institute, Guangzhou, 510663.
2. National Institutes for Food and Drug Control, Beijing, 100050.
- Publication Type:Journal Article
- Keywords:
European Union;
classification supervision system;
in vitro diagnostic medical device;
regulation
- MeSH:
European Union;
Industry;
Reagent Kits, Diagnostic
- From:
Chinese Journal of Medical Instrumentation
2021;45(6):674-679
- CountryChina
- Language:Chinese
-
Abstract:
By analyzing and comparing the IVD product classification supervision system in the EU's new IVDR, old IVDD and related guidance documents, concepts of related regulatory reforms were analyzed and explored, to provide references for industrial personnel to understand and master the new EU IVD classification system, and for China's ongoing classification management reform.
