title: [A pilot study on the quality management system of in-vitro diagnostic reagents].
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.
authors.affiliation: Shanghai Municipal Drug and Medical Device Evaluation Center.
authors.forename: Xin
authors.initials: X
authors.lastname: Liu
authors.forename: Jia-hua
authors.initials: JH
authors.lastname: Huang
authors.forename: Feng-ling
authors.initials: FL
authors.lastname: Xu
authors.forename: Ze
authors.initials: Z
authors.lastname: Wang
authors.forename: Wei-kang
authors.initials: WK
authors.lastname: Gu
mesh_terms: D002681:China; D004864:Equipment and Supplies / Q000592:standards; D006801:Humans; D007202:Indicators and Reagents / Q000737:chemistry / Q000592:standards; D010865:Pilot Projects; D011785:Quality Assurance, Health Care / Q000458:organization & administration*; D011786:Quality Control; D011933:Reagent Kits, Diagnostic / Q000592:standards; D017751:Safety Management; D013678:Technology, Pharmaceutical / Q000458:organization & administration* / Q000592:standards; D017749:Total Quality Management
chemical_list: D007202:Indicators and Reagents; D011933:Reagent Kits, Diagnostic