Changes and Related Reflections on the European Union's in Vitro Diagnostic Medical Device Classification Supervision System / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation
;
(6): 674-679, 2021.
Article
in Chinese
| WPRIM
| ID: wpr-922081
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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Reagent Kits, Diagnostic
/
European Union
/
Industry
Type of study:
Diagnostic study
Language:
Chinese
Journal:
Chinese Journal of Medical Instrumentation
Year:
2021
Type:
Article
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