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1、医疗器械召回管理办法(试行)（Measuresforthemanagementofrecallofmedicaldevices(TrialImplementation)）Measuresforthemanagementofrecallofmedicaldevices(TrialImplementation)Measuresforthemanagementofrecallofmedicaldevices(TrialImplementation)(DecreeNo.eighty-secondoftheMinistryofhealthpromulgat
2、edinMay20,2011andimplementedsinceJuly1,2011)Chapter1GeneralProvisionsArticle1inordertostrengthenthesupervisionandmanagementofmedicalequipment,protectionofhumanhealthandsafety,accordingto"medicalequipmentsupervisionandmanagementregulations","StateCouncilonstrengtheningthefooda
3、ndproductsafetysupervisionandmanagementofspecialprovisions",formulated.ThesemeasuresareapplicabletotherecallandsupervisionofsecondmedicaldevicessoldwithintheterritoryofthePeople'sRepublicofChina.Thirdthemedicalinstrumentsinthiswaytorecall,referstothemedicalequipmentmanufactur
4、ingenterprisesinaccordancewiththeprovisionsoftheprocedurehavebeenlistedforsaleofadefectivecategory,typeorbatchofproducts,takewarning,inspection,repair,relabelling,modifyandeliminatethedefectbehaviorofperfectingtheinstructions,softwareupgrades,replacement,recoverythedestructio
5、n,etc..ThedefectsmentionedinthefourthMeasuresrefertotheunreasonablerisksthatmedicaldevicesmayendangerhumanhealthandlifesafetyundernormaluse.Fifthmedicaldevicemanufacturersarethemainbodyofcontrolandeliminationofproductdefects,andshouldberesponsibleforthesafetyoftheproductsthey
6、produce.Sixthmedicalequipmentproductionenterpriseshallestablishandimprovethemedicaldevicerecallsysteminaccordancewiththeprovisionsofthesemeasures,therelevantinformationcollectionofmedicalsecurity,investigation,evaluationofmedicaldevicesmaybedefective,defectivemedicaldevicerec
7、alltimely.Businessenterprises,theuseofmedicaldevicesshallassistthemedicalequipmentmanufacturingenterprisestofulfilltheobligationtorecall,inatimelymanner,inaccordancewiththerequirementsoftherecallplansofmedicaldevicerecallinformationfeedback,controlandrecoveryofmedicaldefects.
8、Seventhenterprises,medicaldevicesbusinessunitfoundthatthemanagementa
