RESUMEN
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.
Asunto(s)
Humanos , China , Equipos y Suministros , Estándares de Referencia , Indicadores y Reactivos , Química , Estándares de Referencia , Proyectos Piloto , Garantía de la Calidad de Atención de Salud , Control de Calidad , Juego de Reactivos para Diagnóstico , Estándares de Referencia , Administración de la Seguridad , Tecnología Farmacéutica , Estándares de Referencia , Gestión de la Calidad TotalRESUMEN
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.