ABSTRACT
This article makes a pilot study on the key points of the quality management system of in-vitro diagnostic reagents by analyzing the technical characteristics and production methods of these products as well as the status in quo, and problems the in-vitro diagnostic reagent industry in China is facing nowadays. It can serve as a reference to the supervision departments and the manufacturers in this field which are establishing and running the quality management system.
Subject(s)
Humans , China , Equipment and Supplies , Reference Standards , Indicators and Reagents , Chemistry , Reference Standards , Pilot Projects , Quality Assurance, Health Care , Quality Control , Reagent Kits, Diagnostic , Reference Standards , Safety Management , Technology, Pharmaceutical , Reference Standards , Total Quality ManagementABSTRACT
This article introduces the definition, classification, premarket admission and other administering specialities about In-Vitro Diagnostic Reagents in the U.S.A. and China. And by analyzing manufacture and administration of In-Vitro Diagnostic Reagents in our country, It is pointed out that a suitable administering model in accordance with the characteristics of In-Vitro Diagnostic Reagents should be adopted to perfect the administration.