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1、MedicalDeviceRecallAdministrationMethod(DraftforComment)(OrderofMOHNo.82)IssuedonMay20th,2011OrderoftheMinistryofHealthofPeople’sRepublicofChinaNo.82TheAdministrativeMeasuresonRecallforMedicalApparatusandInstruments(ForTrialImplementation)asexaminedandapprovedbyatthe
2、ministerialmeetingoftheMinistryofHealthonJune28,2010isnowpromulgatedandshallbeimplementedasofJuly1,2011.MinisterChenZhuMay20,2011AdministrativeMeasuresonRecallforMedicalApparatusandInstruments(ForTrialImplementation)Chapter1GeneralProvisionsArticle1Inaccordancewithth
3、eRegulationsforthe“SupervisionandAdministrationofMedicalDevices”andthe“SpecialProvisionsoftheStateCouncilontheSafetySupervisionandAdministrationofFoodandOtherProducts”,thismethodisformulatedtostrengthenthesupervisionandadministrationofmedicaldevices,inordertosecurepe
4、ople’shealthandsafety.Article2ThismethodappliestotherecallanditssupervisionandadministrationofallthemedicaldevicessoldinthePeople’sRepublicofChina.Article3Themedicaldevicerecallmentionedinthismethodreferstothatthemedicaldevicemanufacturers,inaccordancewithregulatedpr
5、ocedures,eliminatethehazardsoftheirmarketedproductswithpotentialhazards,bywaysofwarning,examining,repairing,relabeling,modifyingtheinstructions,updatingthesoftware,replacing,recovering,destroyingandothermethods.Article4Thepotentialhazardsmentionedinthismethodrefersto
6、theunreasonabledangerstohumanhealthandsafetythemedicaldeviceshaveinnormalusingconditions.Article5Medicalinstrumentsmanufacturerswhicharethesubjecttocontrolandeliminateproductdefectsshallbeliableforthesafetyoftheirproducts.Article6Medicaldevicemanufacturersshall,inacc
7、ordancewiththismethod,establishandperfecttheirmedicaldevicerecallsystem,collecttherelevantsafetyinformationofthemedicaldevices,searchandassessthemedicaldevicesthatmayhavepotentialhazards,andrecallthosewithsuchhazards.Themarketersandusersofthemedicaldevicesshallassist
8、themanufacturersinperformingthedutyofrecalling,timelytransmitandfeedbacktherecallinformationaccordingtotherecallplans,andcontroland
