《医疗器械临床试验质量管理规范》英文版Word文件下载.docx

《医疗器械临床试验质量管理规范》英文版Word文件下载.docx

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《医疗器械临床试验质量管理规范》英文版@#@StateFoodandDrugAdministrationNationalHealthandFamilyPlanningCommissionNumbertwenty-fifth<@#@medicalequipmentspecificationforthequalitycontrolofclinicaltrialof>@#@hasbeenstatefoodandDrugAdministrationintheexecutivemeetingofthe,nationalhealthandFamilyPlanningCommission,directorofthecommitteemeetingexaminedandadopted,isherebypromulgated,sinceJune1,2016implementation.DirectorBiJingquanDirectorLiBinMarch1,2016StandardforqualitymanagementofmedicaldeviceclinicaltrialsChapteroneisthefirstchapterThefirstistostrengthenthemanagementofmedicaldeviceclinicaltrials,themaintenanceprocessforclinicaltrialsofmedicaldevicesinrightsandinterests,andtoguaranteethemedicaldeviceclinicaltrialsprocessspecification,realresults,science,reliableandtraceable,accordingto<@#@thesupervisionandadministrationofMedicalDevicesRegulations>@#@formulatedthisspecification.Article2withintheterritoryofthepeople'@#@sRepublicofChinatocarryouttheclinicaltrialofmedicalapparatusandinstruments,shallcomplywiththespecification.Thisspecificationcoversthewholeprocessofmedicaldeviceclinicaltrials,includingdesignofclinicaltrials,theimplementationof,monitoring,verification,inspection,anddataacquisition,record,andanalyzethesummarizingandreporting.Thethirdsectionofthisspecificationreferredtointheclinicaltrialofmedicalapparatusandinstruments,referstointheaccreditationofmedicalinstrumentclinicaltrialinstitution,intendstoapplyfortheregistrationofmedicaldeviceinthenormalconditionsofuseissafeandeffectiveforconfirmationorverificationprocess.Fourthclinicaltrialsofmedicaldevicesshallcomplywiththeprinciplesoflaw,ethicalprinciplesandscientificprinciples.Article5atorabovetheprovinciallevelfoodanddrugsupervisionandmanagementdepartmentsresponsibleforthesupervisionandmanagementofmedicaldeviceclinicaltrials.Healthandfamilyhealthdepartmentincharge,withinitsscopeoffunctionsandduties,strengthentheclinicaltrialofmedicalapparatusandinstrumentsmanagement.Foodanddrugsupervisionandmanagementdepartments,healthandfamilyhealthdepartmentsshouldestablishthemedicalqualityofclinicaltrialmanagementinformationreportingmechanism,strengthentheclassIIImedicaldevices,includedinthenationalconfigurationoflargemedicalequipmentqualitymanagementobjectiveofmedicalapparatusandinstrumentstocarryoutexaminationandapprovalofclinicaltrialsandthecorrespondingclinicaltrialsupervisionandmanagementofdatacommunications.ThesecondchapteristhepreparationbeforeclinicaltrialArticle6theclinicaltrialofmedicalapparatusandinstrumentsshallhavesufficientscientificbasisandtheclearpurposeofthetest,andweighonexpectedandthepublichealthbenefitandrisk,expectedbenefitshouldexceedthepossibledamage.Article7beforeclinicaltrials,thesponsorshalltestdoneinpreclinicalstudiesofmedicalapparatusandinstruments,includingproductdesign（structure,workingprincipleandmechanismofaction,isexpectedtouseandscopeofapplication,theapplicabletechnicalrequirementsandqualityinspection,animaltestingandriskanalysisandresultsshouldbeabletosupporttheclinicaltrial.Qualityinspectionresultsincludingselfinspectionreportandaqualifiedinspectionagencyissuedayearwithintheproductregistrationinspectionreport.Priortotheeighthclinicaltrials,theapplicantshouldprepareadequatetestingofmedicalequipment.Thedevelopmentofthetestwithmedicalequipmentshallmeettheapplicablerequirementsofthemedicaldevicequalitymanagementsystem.Thenineclinicaltrialsofmedicaldevicesshallbeintwoormorethantwomedicaldeviceclinicaltrialinstitution.Selectedtestinginstitutionsshallbewithoutqualificationaccreditationofmedicalinstrumentclinicaltrialinstitution,andfacilitiesandconditionsshallmeetthesafetyeffectivelyclinicaltrialexperience.Researchersshouldbeabletobeartheclinicaltrialsofspecialty,qualificationandabilityandtrained.QualificationofmedicalinstrumentclinicaltrialinstitutionidentifiedmanagementmeasuresshallbeformulatedseparatelybytheStateFoodanddrugadministrationshall,jointlywiththeMinistryofhealthandFamilyPlanningCommission.Article10beforeclinicaltrials,thesponsorandclinicaltrialinstitutionsandresearchersshouldtestdesign,testqualitycontrol,testthedivisionofresponsibilities,sponsortobearthecostsassociatedwiththeclinicaltrialandtestinmayoccurdamagedealingwithprinciplestoreachawrittenagreement.@#@Article11clinicaltrialsshouldobtainconsentoftheclinicaltrialofmedicalapparatusandinstrumentsinstitutionalethicscommittee.Included