资源描述：
《(英文版)医疗器械临床试验质量管理规范方案》由会员上传分享，免费在线阅读，更多相关内容在应用文档-天天文库。
1、FG-20160601025GoodClinicalPracticeforMedicalDevices(No.25OrderofCFDAandNHFPC)OrderofChinaFoodandDrugAdministrationandNationalHealthandFamilyPlanningCommissionofChinaNo.25AdoptedatthemeetingofCFDAandNHFPC,thispracticeisherebypromulgated,andshalltakeeffectasofJune1,2016.
2、 Director BiJingquanDirectorLiBinMarch1,2016GoodClinicalPracticeforMedicalDevicesChapter1GeneralprovisionsArticle1ThePracticeisformulatedinaccordancewiththeRegulationsontheSupervisionandAdministrationofMedicalDevicesinordertofurtherstrengthenthemanagementofclin
3、icaltrialsofmedicaldevices,protecttherightsandbenefitsoftrialsubjectsandassuretheclinicaltrialprocedurestandard,truthful,scientific,reliableandtraceable.Article2AlltheclinicaltrialsofmedicaldeviceswithintheterritoryofthePeople'sRepublicofChinashallbeconductedaccordingtothepract
4、ice.ThePracticecoversthewholeprocedureofclinicaltrialofmedicaldevices,includingtheprotocoldesign,conduction,monitoring,audit,inspection,collectionofdata,record,analysisandsummaryandreportofclinicaltrial,etc.Article3ClinicaltrialofmedicaldevicesmentionedinthisPracticereferstothe
5、processofconfirmingandverifyingthesafetyandefficacyofthemedicaldeviceintendedtoapplyregistrationundernormalconditioninqualifiedclinicaltrialinstitutionsofmedicaldevices.Article4Clinicaltrialsofmedicaldevicesshallcomplywiththeprincipleoflegal,ethicandscience.Article5Foodanddrugr
6、egulatoryauthorityaboveprovincelevelareresponsibleforthesupervisionandmanagementofclinicaltrailsofmedicaldevices.ThecompetentdepartmentofNationalHealthandFamilyPlanningCommissionshallstrengthenthemanagementofclinicaltrailsofmedicaldeviceswithin the scope of its duties.Foodanddr
7、ugregulatoryauthorityandthecompetentdepartmentofNHFPCshallestablishtheinformationnotificationsystemonqualitymanagementofmedicaldeviceclinicaltrialsandstrengthentheinformationnotificationontheapprovalforconductingclinicaltrialofClassIIImedicaldevicesandthemedicaldeviceslistedint
8、hemanagementcatalogoflarge medical equipmentcollocatio
