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1、一次性使用无菌医疗器械监督管理办法（Supervisionandmanagementofsterilemedicaldevicesforonetimeuse）Chapter1GeneralProvisionsArticle1inordertostrengthenthesupervisionandmanagementofdisposablesterilemedicalinstrumentsandensurethesafetyandeffectivenessoftheproducts,themeasuresa
2、reformulatedaccordingtotheregulationsonthesupervisionandadministrationofmedicaldevices.Thedisposableasepticmedicalinstruments(hereinafterreferredtoassterileinstruments)referredtointhesecondmeasuresrefertothemedicalinstrumentswhicharesterile,pyrogenfree,an
3、dqualifiedafterexaminationandaredirectlyusedintheperiodofvalidity.Sterileinstrumentsaccordingtothe"listofsterilemedicaldevicesforonetimeuse"(hereinafterreferredtoas"directory")implementationofthekeysupervisionandmanagement.Thecatalogue(seeAnnex)ispromulga
4、tedandadjustedbytheStateDrugadministration.Thirdunitsorindividualsengagedintheproduction,operation,use,supervisionandmanagementofasepticinstrumentswithintheterritoryofthePeople'sRepublicofChinashallabidebythesemeasures.Thesupervisionandmanagementofproduct
5、ioninthesecondchapterThefourthproductionofsterileequipmentshouldbeimplementedbytheStateDrugAdministrationof"sterilemedicaldeviceproductionmanagementnorms"andasepticequipment"productionrules".Sterileinstrumentsmustbeinspectedstrictlyaccordingtothestandards
6、,andthosewhohavenotbeeninspectedorinspectedarenotallowedtoleavethefactory.Fifthproductionofsterileequipmentshouldbeinaccordancewiththe"rulesfortheimplementationoftheproduction"requirementsforprocurementofmaterials,components.Theenterpriseshallkeepcomplete
7、purchaseandsalenotesandrecords,andthenotesandrecordsshouldbekepttotheexpirationoftwoyearsaftertheexpirationoftheproduct.Recordofpurchaseandsaleshouldinclude:nameoftheunitsoldorpurchased,quantityofsupplyorpurchase,productname,modelspecification,batchnumber
8、,batchnumberofsterilization,expirationdateofproduct,etc..Sixthproductionenterprisesshouldcomplywiththe"rulesfortheimplementationoftheprovisionsof"conditionsofproductionunitspurchasedpackagingmaterialsorpackagingcont
