Acceptance Criteria of IVD Reagent And Registratio
InordertostrengthenthemanagementofIVDenterprisesandmakeastandardforIVDreagententerprise,NationalBureauhasdrawnuptheAcceptanceCriteriaofIVDReagentandAcceptanceCriteriaofInVitroDiagnostics(IVD)ReagentRegistrationProcedures.Eachprovince,districtorcitywhichmeetstheAcceptanceCriteriaofIVDReagentandAcceptanceCriteriaofInVitroDiagnostics(IVD)ReagentRegistrationProcedures,canbereceivedDrugSupplyCertificateandMedicalDeviceDistributionBusinessLicense,whoselineofbusinessisonlyforIVDreagent.IfIVDreagententerprisesmentionedabovewanttoexpanditslineofbusiness,ithastoapplyforDrugSupplyCertificateorMedicalDeviceDistributionBusinessLicenseagain.EnterprisesmustdobusinessonthebaseofGoodSupplyPracticeforPharmaceuticalProducts(GSP).O***unda’sprofessionaladvisorandc***ultantteam,withexperiencesofseniormanagerialpositionofnationalandinternationalmedicaldevicemanufacturersandprofessionalbackgroundofdoinglong-termregistrationofmedicaldevices,enjoyedalongandfriendlyrelati***hipwithnationalandinternationalcertificationbodies,nationalmedicaldevicestestingorganizati***.)