《医疗器械临床试验质量管理规范》英文版.docx

《医疗器械临床试验质量管理规范》英文版.docx

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《医疗器械临床试验质量管理规范》英文版

StateFoodandDrugAdministration

NationalHealthandFamilyPlanningCommission

Numbertwenty-fifth

hasbeenstatefoodandDrugAdministrationintheexecutivemeetingofthe,nationalhealthandFamilyPlanningCommission,directorofthecommitteemeetingexaminedandadopted,isherebypromulgated,sinceJune1,2016implementation.

DirectorBiJingquan

DirectorLiBin

March1,2016

Standardforqualitymanagementofmedicaldeviceclinicaltrials

Chapteroneisthefirstchapter

Thefirstistostrengthenthemanagementofmedicaldeviceclinicaltrials,themaintenanceprocessforclinicaltrialsofmedicaldevicesinrightsandinterests,andtoguaranteethemedicaldeviceclinicaltrialsprocessspecification,realresults,science,reliableandtraceable,accordingtoformulatedthisspecification.

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.

Thesecondchapteristhepreparationbeforeclinicaltrial

Article6theclinicaltrialofmedicalapparatusandinstrumentsshallhavesufficientscientificbasisandtheclearpurposeofthetest,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.

Article11clinicaltrialsshouldobtainconsentoftheclinicaltrialofmedicalapparatusandinstrumentsins