《医疗器械临床试验质量管理规范》英文版.docx

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1、《医疗器械临床试验质量管理规范》英文版StateFoodandDrugAdministrationNationalHealthandFamilyPlanningCommissionNumbertwenty-fifthhasbeenstatefoodandDrugAdministrationintheexecutivemeetingofthe,nationalhealthandFam

2、ilyPlanningCommission,directorofthecommitteemeetingexaminedandadopted,isherebypromulgated,sinceJune1,2016implementation.DirectorBiJingquanDirectorLiBinMarch1,2016StandardforqualitymanagementofmedicaldeviceclinicaltrialsChapteroneisthefirstchapterThefirstistost

3、rengthenthemanagementofmedicaldeviceclinicaltrials,themaintenanceprocessforclinicaltrialsofmedicaldevicesinrightsandinterests,andtoguaranteethemedicaldeviceclinicaltrialsprocessspecification,realresults,science,reliableandtraceable,accordingto

4、dadministrationofMedicalDevicesRegulations>formulatedthisspecification.Article2withintheterritoryofthepeople'sRepublicofChinatocarryouttheclinicaltrialofmedicalapparatusandinstruments,shallcomplywiththespecification.Thisspecificationcoversthewholeprocessofmedi

5、caldeviceclinicaltrials,includingdesignofclinicaltrials,theimplementationof,monitoring,verification,inspection,anddataacquisition,record,andanalyzethesummarizingandreporting.Thethirdsectionofthisspecificationreferredtointheclinicaltrialofmedicalapparatusandins

6、truments,referstointheaccreditationofmedicalinstrumentclinicaltrialinstitution,intendstoapplyfortheregistrationofmedicaldeviceinthenormalconditionsofuseissafeandeffectiveforconfirmationorverificationprocess.Fourthclinicaltrialsofmedicaldevicesshallcomplywithth

7、eprinciplesoflaw,ethicalprinciplesandscientificprinciples.Article5atorabovetheprovinciallevelfoodanddrugsupervisionandmanagementdepartmentsresponsibleforthesupervisionandmanagementofmedicaldeviceclinicaltrials.Healthandfamilyhealthdepartmentincharge,withinitss

8、copeoffunctionsandduties,strengthentheclinicaltrialofmedicalapparatusandinstrumentsmanagement.Foodanddrugsupervisionandmanagementdepartments,healthandfamilyhealthdepartmentsshoulde