RESUMO
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.
Assuntos
Humanos , China , Equipamentos e Provisões , Padrões de Referência , Indicadores e Reagentes , Química , Padrões de Referência , Projetos Piloto , Garantia da Qualidade dos Cuidados de Saúde , Controle de Qualidade , Kit de Reagentes para Diagnóstico , Padrões de Referência , Gestão da Segurança , Tecnologia Farmacêutica , Padrões de Referência , Gestão da Qualidade TotalRESUMO
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.