医疗器械生产质量管理规范（medical equipment production quality management specification）

医疗器械生产质量管理规范（MEDICALEQUIPMENTPRODUCTIONQUALITYMANAGEMENTSPECIFICATION）SPECIFICATIONFORQUALITYCONTROLOFMEDICALDEVICEPRODUCTIONTRIALIMPLEMENTATIONGENERALPROVISIONSARTICLE1INORDERTOSTRENGTHENTHESUPERVISIONANDADMINISTRATIONOFMEDICALDEVICEPRODUCTIONANDSTANDARDIZETHEMEDICALEQUIPMENTPRODUCTIONQUALITYMANAGEMENTSYSTEM,THISREGULATIONISFORMULATEDINACCORDANCEWITHTHEREGULATIONSONTHESUPERVISIONANDADMINISTRATIONOFMEDICALDEVICESANDRELEVANTLAWSANDREGULATIONSSECOND,THISSPECIFICATIONISTHEMEDICALEQUIPMENTPRODUCTIONQUALITYMANAGEMENTSYSTEMOFTHEBASICCRITERIA,APPLICABLETOMEDICALEQUIPMENTDESIGN,DEVELOPMENT,PRODUCTION,SALEANDSERVICEOFTHEWHOLEPROCESSTHIRDMEDICALDEVICEMANUFACTURERSHEREINAFTERREFERREDTOASPRODUCTIONENTERPRISESSHALL,ACCORDINGTOTHECHARACTERISTICSOFTHEPRODUCTS,ESTABLISHTHEQUALITYMANAGEMENTSYSTEMINACCORDANCEWITHTHEREQUIREMENTSOFTHISREGULATION,ANDMAINTAINEFFECTIVEOPERATIONASANINTEGRALPARTOFTHEQUALITYMANAGEMENTSYSTEM,THEPRODUCTIONENTERPRISESHOULDIMPLEMENTRISKMANAGEMENTINTHEWHOLEPROCESSOFPRODUCTREALIZATIONTHESECONDCHAPTERMANAGEMENTRESPONSIBILITIESFOURTHPRODUCTIONENTERPRISESSHALLSETUPCORRESPONDINGORGANIZATIONSANDORGANIZATIONS,SPECIFYTHEFUNCTIONSANDPOWERSOFEACHINSTITUTION,ANDSPECIFYTHEFUNCTIONSOFQUALITYMANAGEMENTTHEPRODUCTIONMANAGEMENTDEPARTMENTANDTHEHEADOFTHEQUALITYCONTROLDEPARTMENTSHALLNOTHOLDCONCURRENTLYWITHEACHOTHERTHEPERSONINCHARGEOFTHEFIFTHPRODUCTIONENTERPRISESHALLHAVEANDPERFORMTHEFOLLOWINGDUTIES1ORGANIZINGANDFORMULATINGTHEQUALITYPOLICYANDQUALITYOBJECTIVESOFTHEMANUFACTURINGENTERPRISESTWOORGANIZING,PLANNINGANDDEFININGTHEPRODUCTREALIZATIONPROCESSTOENSURETHATCUSTOMERREQUIREMENTSAREMETTHREEENSURETHEHUMANRESOURCES,INFRASTRUCTUREANDWORKINGENVIRONMENTNEEDEDFORTHEEFFECTIVEOPERATIONOFTHEQUALITYMANAGEMENTSYSTEMFOURORGANIZEMANAGEMENTREVIEWANDKEEPRECORDSFIVEASSIGNSPECIALPERSONNELANDDEPARTMENTSTOCOLLECTRELEVANTLAWSANDREGULATIONS,ANDENSURETHEIMPLEMENTATIONOFTHERELEVANTLAWSANDREGULATIONSWITHINTHEPRODUCTIONENTERPRISETHEPERSONINCHARGEOFTHESIXTHPRODUCTIONENTERPRISESHALLDETERMINEAREPRESENTATIVEOFTHEMANAGEMENTTHEMANAGEMENTREPRESENTATIVEISRESPONSIBLEFORESTABLISHING,IMPLEMENTINGANDMAINTAININGTHEQUALITYMANAGEMENTSYSTEM,REPORTINGONTHEQUALITYMANAGEMENTSYSTEMSOPERATIONANDIMPROVEMENTNEEDS,ANDIMPROVINGTHESTAFFSAWARENESSOFTHEREQUIREMENTSOFTHEREGULATIONSANDCUSTOMERREQUIREMENTSTHETHIRDCHAPTER,RESOURCEMANAGEMENTTHEPERSONINCHARGEOFTHESEVENTHPRODUCTION,TECHNOLOGYANDQUALITYMANAGEMENTOFMEDICALDEVICESSHALLBEFAMILIARWITHTHERELEVANTLAWSANDREGULATIONS,WITHQUALITYMANAGEMENTEXPERIENCE,MAKECORRECTJUDGEMENTANDTREATMENTABILITYOFPRODUCTIONANDQUALITYMANAGEMENTOFPRACTICALPROBLEMSEIGHTHPERSONNELENGAGEDINWORKAFFECTINGPRODUCTQUALITYSHALLUNDERGOCORRESPONDINGTECHNICALTRAINING,WITHRELEVANTTHEORETICALKNOWLEDGEANDPRACTICALOPERATIONSKILLSNINTHPRODUCTIONENTERPRISESSHALLHAVEANDMAINTAINTHENECESSARYPRODUCTIONSITES,PRODUCTIONEQUIPMENT,MONITORINGANDMEASURINGFACILITIES,STORAGESITESANDOTHERINFRASTRUCTUREANDWORKINGENVIRONMENTREQUIREDFORTHEPRODUCTIONOFPRODUCTSTHEPRODUCTIONENVIRONMENTSHALLMEETTHEREQUIREMENTSOFRELEVANTREGULATIONSANDTECHNICALSTANDARDSTHEFOURTHCHAPTERDOCUMENTSANDRECORDSTENTHPRODUCTIONENTERPRISESSHALLESTABLISHAQUALITYMANAGEMENTSYSTEMANDFORMDOCUMENTSTHEFORMATIONOFTHEQUALITYMANAGEMENTSYSTEMDOCUMENTATIONSHALLINCLUDETHEQUALITYPOLICYANDQUALITYOBJECTIVES,QUALITYMANUAL,THISSPECIFICATIONPROGRAMDOCUMENTS,TECHNICALDOCUMENTS,OPERATIONINSTRUCTIONSANDRECORDS,ANDOTHERDOCUMENTSREQUIREDBYTHEREGULATIONSTHEQUALITYMANUALSHALLMAKEACOMMITMENTANDREGULATIONTOTHEQUALITYMANAGEMENTSYSTEMOFTHEMANUFACTURINGENTERPRISEELEVENTHPRODUCTIONENTERPRISESSHALLPREPAREANDMAINTAINTHETECHNICALDOCUMENTATIONOFTHEMEDICALINSTRUMENTSPRODUCEDINCLUDINGPRODUCTSPECIFICATIONS,PRODUCTIONPROCESSSPECIFICATIONS,INSPECTIONANDTESTSPECIFICATIONS,INSTALLATIONANDSERVICESPECIFICATIONSTWELFTHPRODUCTIONENTERPRISESSHALLESTABLISHDOCUMENTCONTROLPROCEDURESANDFORMDOCUMENTS,WHICHSTIPULATETHEFOLLOWINGDOCUMENTCONTROLREQUIREMENTS1THEDOCUMENTSHALLBEREVIEWEDANDAPPROVEDBEFOREPUBLICATIONTOENSURETHESUITABILITYANDADEQUACYOFTHEDOCUMENTANDTOMEETTHEREQUIREMENTSOFTHISSPECIFICATIONTWOWHENTHEDOCUMENTSAREUPDATEDORMODIFIED,THEYSHALLBEREVIEWEDANDAPPROVEDINACCORDANCEWITHTHEPROVISIONS,ANDSHALLBEABLETOIDENTIFYTHECHANGESANDREVISIONSTATUSOFTHEDOCUMENTSSOASTOENSURETHATTHEAPPLICABLEVERSIONSAREAVAILABLEATTHEJOBSITETHREETHEMANUFACTURINGENTERPRISESHALLENSURETHATTHERELEVANTMEDICALDEVICEREGULATIONSANDOTHERFOREIGNDOCUMENTSAREIDENTIFIEDANDCONTROLLEDFOURTHEMANUFACTURINGENTERPRISESHALLIDENTIFYTHERETAINEDDOCUMENTSSOASTOPREVENTINCORRECTUSETHIRTEENTHMANUFACTURINGENTERPRISESSHALLKEEPOBSOLETETECHNICALDOCUMENTSANDDETERMINETHEIRSTORAGEPERIODINORDERTOMEETTHENEEDSOFPRODUCTMAINTENANCEANDPRODUCTQUALITYRESPONSIBILITYTRACEABILITYFOURTEENTHPRODUCTIONENTERPRISESSHALLSETUPRECORDSMANAGEMENTPROCEDURESANDFORMDOCUMENTSTHATSPECIFYTHEREQUIREMENTSFORTHEIDENTIFICATION,STORAGE,PROTECTION,RETRIEVAL,STORAGE,DURATIONANDDISPOSALOFRECORDSRECORDSSHOULDMEETTHEFOLLOWINGREQUIREMENTS1RECORDSARECLEAR,COMPLETE,EASYTOIDENTIFYANDRETRIEVE,ANDTOPREVENTBREAKAGEANDLOSSTWOTHELIFEOFAMEDICALDEVICEMANUFACTURINGENTERPRISERECORDKEEPINGPERIODISATLEASTEQUIVALENTTOTHEPROVISIONSOFTHEPRODUCTIONENTERPRISES,BUTTHERELEASEOFPRODUCTSFROMTHEPRODUCTIONDATEOFNOTLESSTHAN2YEARS,ORMEETTHEREQUIREMENTSOFRELEVANTLAWSANDREGULATIONS,ANDTRACEABILITYTHEFIFTHCHAPTERISTHEDESIGNANDDEVELOPMENTFIFTEENTHPRODUCTIONENTERPRISESSHALLSETUPDESIGNCONTROLPROCEDURESANDFORMDOCUMENTSTOPLANANDCONTROLTHEDESIGNANDDEVELOPMENTPROCESSOFMEDICALDEVICESTHESIXTEENTHPRODUCTIONENTERPRISESINTHEDESIGNANDDEVELOPMENTPLANNING,SHALLDETERMINETHEDESIGNANDDEVELOPMENTSTAGESANDEACHSTAGEOFTHEREVIEW,VERIFICATION,VALIDATIONANDDESIGNTRANSFERACTIVITIES,SHOULDIDENTIFYANDDETERMINETHEACTIVITIESOFVARIOUSDEPARTMENTSANDTHEINTERFACEDESIGNANDDEVELOPMENT,CLEARRESPONSIBILITIESANDDIVISIONOFLABORTHESEVENTEENTHDESIGNANDDEVELOPMENTINPUTSSHALLINCLUDETHEINTENDEDUSE,THESPECIFIEDFUNCTIONS,PERFORMANCEANDSAFETYREQUIREMENTS,REGULATORYREQUIREMENTS,RISKMANAGEMENT,CONTROLMEASURES,ANDOTHERREQUIREMENTSINPUTTODESIGNANDDEVELOPMENTSHALLBEREVIEWEDANDAPPROVEDANDRECORDSMAINTAINEDTHEEIGHTEENTHDESIGNANDDEVELOPMENTOUTPUTSSHALLMEETTHEINPUTREQUIREMENTS,PROVIDETHEBASISFORPROCUREMENT,PRODUCTIONANDSERVICES,PRODUCTCHARACTERISTICSANDACCEPTANCECRITERIADESIGNANDDEVELOPMENTOUTPUTSSHALLBEAPPROVEDANDMAINTAINEDNINETEENTHPRODUCTIONENTERPRISESHALLCARRYOUTTHEDESIGNANDDEVELOPMENTINTHEPROCESSOFDESIGNANDDEVELOPMENTTOPRODUCTIONTRANSFORMATION,INORDERTOMAKETHEOUTPUTOFDESIGNANDDEVELOPMENTINPRODUCTSPECIFICATIONSCANBEVERIFIEDBEFOREEVENTUALLY,ENSURETHATTHEDESIGNANDDEVELOPMENTOUTPUTSFORPRODUCTIONTWENTIETHPRODUCTIONENTERPRISESSHALLARRANGEASSESSMENTATTHEAPPROPRIATESTAGEOFDESIGNANDDEVELOPMENT,ANDKEEPRECORDSOFTHERESULTSOFTHEREVIEWANDANYNECESSARYMEASURESTWENTYFIRSTMANUFACTURINGENTERPRISESSHALLVERIFYTHEDESIGNANDDEVELOPMENTTOENSURETHATTHEDESIGNANDDEVELOPMENTOUTPUTSMEETTHEINPUTREQUIREMENTS,ANDMAINTAINRECORDSOFTHEVALIDATIONRESULTSANDANYNECESSARYMEASURESTHETWENTYSECONDMANUFACTURINGENTERPRISESHALLCONFIRMTHEDESIGNANDDEVELOPMENTTOENSURETHATTHEPRODUCTMEETSTHEAPPLICABLEREQUIREMENTSORINTENDEDUSESANDMAINTAINSRECORDSOFTHEVALIDATIONRESULTSANDANYNECESSARYMEASURESCLINICALEVALUATIONORPERFORMANCEEVALUATIONCANBEUSEDCLINICALTRIALSSHOULDCOMPLYWITHTHEREQUIREMENTSOFCLINICALTRIALCODESFORMEDICALDEVICESTWENTYTHIRDMANUFACTURINGENTERPRISESSHALLIDENTIFYANDKEEPRECORDSOFCHANGESINDESIGNANDDEVELOPMENTWHENNECESSARY,THEDESIGNANDDEVELOPMENTCHANGESSHALLBEREVIEWED,VALIDATEDANDVALIDATEDANDAPPROVEDPRIORTOIMPLEMENTATIONWHENTHESELECTEDMATERIALS,PARTSORPRODUCTSOFFUNCTIONALCHANGESMAYAFFECTTHESAFETYANDEFFECTIVENESSOFMEDICALDEVICESSHOULDBEEVALUATED,BECAUSEOFCHANGESINTHERISK,WHENNECESSARY,TAKEMEASURESTOREDUCETHERISKTOACCEPTABLELEVELS,ANDSHALLCOMPLYWITHTHEREQUIREMENTSOFRELATEDLAWSANDREGULATIONSTWENTYFOURTHPRODUCTIONENTERPRISESSHALL,INTHEWHOLEPROCESSOFDESIGNINGANDDEVELOPINGPRODUCTSINCLUDINGDESIGNANDDEVELOPMENT,FORMULATEREQUIREMENTSFORRISKMANAGEMENT,ANDFORMDOCUMENTSTOKEEPRELEVANTRECORDSTHESIXTHCHAPTERISPURCHASINGTWENTYFIFTHPRODUCTIONENTERPRISESSHALLESTABLISHPROCUREMENTCONTROLPROCEDURESANDFORMDOCUMENTSTOENSURETHATTHEPURCHASEDPRODUCTSMEETTHESPECIFIEDPROCUREMENTREQUIREMENTSWHENPURCHASINGPRODUCTSAREREQUIREDBYLAWS,ADMINISTRATIVEREGULATIONSANDNATIONALMANDATORYSTANDARDS,THEREQUIREMENTSFORPURCHASINGPRODUCTSSHALLNOTBELOWERTHANTHEREQUIREMENTSOFTHELAWSANDADMINISTRATIVEREGULATIONSANDTHEREQUIREMENTSOFTHESTATECOMPULSORYSTANDARDSTHETWENTYSIXTHMANUFACTURINGENTERPRISESHALLDETERMINETHEMANNERANDDEGREEOFCONTROLOVERTHESUPPLIERANDTHEPURCHASEDPRODUCTINACCORDANCEWITHTHEINFLUENCEOFTHEPURCHASEDPRODUCTONSUBSEQUENTPRODUCTREALIZATIONANDFINALPRODUCTWHENTHEPRODUCTISCOMMISSIONEDFORPRODUCTION,THEENTRUSTINGPARTYANDTHEENTRUSTEDPARTYSHALLMEETTHEREQUIREMENTSOFTHERELEVANTREGULATIONSCONCERNINGTHESUPERVISIONANDADMINISTRATIONOFTHEMEDICALDEVICEPRODUCTIONAMANUFACTURINGENTERPRISESHALLEVALUATETHESUPPLIERSABILITYTOMEETITSPROCUREMENTREQUIREMENTSANDFORMULATECRITERIAFORSELECTING,EVALUATINGANDREEVALUATINGTHESUPPLIERAPRODUCTIONENTERPRISESHALLKEEPARECORDOFTHEEVALUATIONRESULTSANDTHEEVALUATIONPROCESSTWENTYSEVENTHTHEPURCHASINGINFORMATIONSHALLBECLEARLYSTATEDTHEPROCUREMENTREQUIREMENTSOFPRODUCTS,INCLUDINGTHEPROCUREMENTOFPRODUCTCATEGORIES,ACCEPTANCECRITERIA,SPECIFICATIONS,SPECIFICATIONS,DRAWINGS,PROCESSREQUIREMENTS,INCLUDINGTHENECESSARYPERSONNELQUALIFICATIONREQUIREMENTS,THEREQUIREMENTSOFQUALITYMANAGEMENTSYSTEMETCAMANUFACTURINGENTERPRISESHALLMAINTAINRELEVANTPURCHASINGINFORMATIONINACCORDANCEWITHTHESCOPEANDEXTENTOFTRACEABILITYREQUIREMENTSTWENTYEIGHTHPRODUCTIONENTERPRISESSHALLEXAMINEORVERIFYTHEPURCHASEDPRODUCTSTOENSURETHATTHEYMEETTHESPECIFIEDPROCUREMENTREQUIREMENTSANDKEEPRECORDSTHESEVENTHCHAPTERISPRODUCTIONMANAGEMENTTWENTYNINTHPRODUCTIONENTERPRISESSHALLPLANANDIMPLEMENTALLPRODUCTIONPROCESSESUNDERCONTROLLEDCONDITIONSTHIRTIETHPRODUCTIONENTERPRISESSHALLPREPAREPRODUCTIONPROCESSREGULATIONS,OPERATIONINSTRUCTIONSANDSOON,ANDDEFINETHEKEYPROCESSESANDSPECIALPROCESSESTHIRTYFIRSTPRODUCTIONENTERPRISESSHOULDUSEAPPROPRIATEPRODUCTIONEQUIPMENT,PROCESSEQUIPMENT,MONITORINGANDMEASUREMENTDEVICES,ANDENSURETHATTHEYAREUNDERCONTROLARTICLETHIRTYSECONDTHEPRODUCTIONPROCESSMUSTBECLEANEDORREMOVEDFROMTHEPRODUCT,THEPRODUCTIONENTERPRISESHALLBEREQUIREDTOCLEANTHEPRODUCTFORMDOCUMENTS,ANDIMPLEMENTEDSTERILEMEDICALDEVICESSHOULDBECONTROLLEDFORCONTAMINATIONANDCONTROLOVERTHESTERILIZATIONPROCESSTHIRTYTHIRDTHEPROCESSSHALLBEVALIDATEDIFTHERESULTSOFTHEMANUFACTURINGPROCESSCANNOTORARENOTEASILYVERIFIEDBYSUBSEQUENTTESTSANDTESTSRECORDSOFACTIVITIESANDRESULTSSHALLBEMAINTAINEDAPRODUCTIONENTERPRISESHALLIDENTIFYTHEQUALIFICATIONOFTHEPROCESSCONFIRMATIONPERSONNELSUCHASTHEPRODUCTIONANDSERVICEPROCESSINCOMPUTERSOFTWAREHASINFLUENCEONTHEQUALITYOFTHEPRODUCTS,ITSHALLPREPARECONFIRMATIONPROCEDURES,TOENSURETHATANYINITIALAPPLICATIONSOFTWAREANDSOFTWARECHANGESBEFOREAPPLICATIONCONFIRMATIONANDRECORDKEEPINGTHIRTYFOURTHPRODUCTIONENTERPRISESSHALLESTABLISHANDMAINTAINTHEPRODUCTIONRECORDSOFEACHBATCHOFPRODUCTSTHEPRODUCTIONRECORDSHALLMEETTHETRACEABILITYREQUIREMENTSOFTHEMEDICALDEVICEANDINDICATETHEQUANTITYANDQUANTITYOFTHESTORAGETHECONTROLPROGRAMOFTHIRTYFIFTHPRODUCTIONENTERPRISESSHALLESTABLISHAPRODUCTIDENTIFICATIONDOCUMENTANDCLEARINTHEWHOLEPROCESSOFPRODUCTREALIZATION,THESUITABLEMETHODSFORPRODUCTIDENTIFICATION,INORDERTOPREVENTCONFUSIONANDMISUSERECOGNITIONTHIRTYSIXTHPRODUCTIONENTERPRISESSHALLIDENTIFYTHEINSPECTIONANDTESTSTATUSOFTHEPRODUCTSTOENSURETHATTHEPRODUCTSTHATAREREQUIREDFORINSPECTIONANDTESTCANBERELEASEDINTHEWHOLEPROCESSOFPRODUCTFORMATIONTHIRTYSEVENTHSTERILEMEDICALDEVICEMANUFACTURERSSHALLESTABLISHPROCEDURESFORTHEVALIDATIONOFSTERILIZATIONPROCEDURESANDDOCUMENTFORMATIONTHESTERILIZATIONPROCESSSHALLBEVALIDATEDINACCORDANCEWITHTHERELEVANTSTANDARDSREQUIREMENTS,PRIORTOINITIALIMPLEMENTATION,RECONFIRMEDASNECESSARY,ANDMAINTAINEDDURINGTHESTERILIZATIONPROCESSTHIRTYEIGHTHMANUFACTURINGENTERPRISESSHALLESTABLISHPROCEDURESFORTRACEABILITYANDFORMDOCUMENTSTHATSPECIFYTHEEXTENT,EXTENT,UNIQUENESS,IDENTITYANDREQUIREDRECORDSOFTHETRACEABILITYOFMEDICALDEVICESTHEPRODUCTIONOFIMPLANTABLEMEDICALDEVICESSHOULDINCLUDERECORDSOFALLPARTS,COMPONENTSANDWORKCONDITIONSTHATMAYCAUSETHEMEDICALDEVICETOFAILTOMEETITSSPECIFIEDREQUIREMENTSWHENREQUIREDFORTRACEABILITYATTHESAMETIME,THEMANUFACTURINGENTERPRISESHALLREQUIRETHEAGENTORDEALERTOKEEPTHERECORDSOFTHEDISTRIBUTIONOFMEDICALEQUIPMENTFORTRACEABILITYAND,WHENNECESSARY,OBTAINTHERECORDTHEINSTRUCTIONS,LABELS,PACKAGESANDLOGOSOFTHETHIRTYNINTHPRODUCTSSHALLCONFORMTOTHECORRESPONDINGREGULATIONSANDSTANDARDSOFTHEMEDICALEQUIPMENTFORTIETHPRODUCTIONENTERPRISESSHALLESTABLISHAPRODUCTPROTECTIONPROCEDUREDOCUMENTANDPROVISIONSFORTHEPRESERVATIONOFPRODUCTREQUIREMENTS,PROTECTIONSHALLINCLUDEIDENTIFICATION,HANDLING,PACKAGING,STORAGEANDPROTECTION,PROTECTIONSHOULDALSOAPPLYTOTHECONSTITUENTPARTSOFAPRODUCTSTORAGEOFMEDICALINSTRUMENTSANDMATERIALSWITHSTORAGEPERIODORSPECIALSTORAGEREQUIREMENTSSHALLBEKEPTINACCORDANCEWITHTHEPRESCRIBEDCONDITIONS,ANDRELEVANTRECORDSSHALLBEKEPTTHEEIGHTHCHAPTERSURVEILLANCEANDMEASUREMENTFORTYFIRSTPRODUCTIONENTERPRISESSHALLESTABLISHMONITORINGANDMEASUREMENTCONTROLPROCEDURES,ANDFORMDOCUMENTSTODETERMINETHENECESSARYMONITORINGANDMEASUREMENTACTIVITIES,CONFIGURETHEAPPROPRIATEDEVICES,MONITORINGANDMEASURINGDEVICESTOCONTROLENSURETHATMONITORINGANDMEASUREMENTACTIVITIESMEETTHEFOLLOWINGREQUIREMENTS1CALIBRATIONORVERIFICATIONOFTHEMEASURINGEQUIPMENTSHALLBECARRIEDOUTREGULARLY,ANDRECORDSSHALLBEMAINTAINEDTWOTHEPROTECTIONREQUIREMENTSFORMONITORINGANDMEASURINGDEVICESDURINGHANDLING,MAINTENANCEANDSTORAGESHALLBESTIPULATED,ANDTHEINSPECTIONRESULTSSHALLBEAVOIDEDTHREEWHENMONITORINGANDMEASURINGDEVICESFAILTOMEETTHEREQUIREMENTS,THEEFFECTIVENESSOFPREVIOUSMONITORINGANDMEASUREMENTRESULTSSHALLBEEVALUATEDANDRECORDEDANDAPPROPRIATEMEASURESSHALLBETAKENFORTHEINSTALLATIONANDAFFECTEDPRODUCTSTOKEEPRECORDSOFDEVICECALIBRATIONANDPRODUCTVALIDATIONRESULTSFOURFORCOMPUTERSOFTWAREUSEDFORMONITORINGANDMEASUREMENT,THEABILITYTOMEETEXPECTEDREQUIREMENTSSHALLBECONFIRMEDPRIORTOINITIALUSEANDRECONFIRMEDASNECESSARYATTHEAPPROPRIATESTAGEOFTHEPRODUCTREALIZATIONPROCESS,THEFORTYSECONDMANUFACTURINGENTERPRISESSHALLMONITORANDMEASURETHEPRODUCTSANDVERIFYTHATTHEPRODUCTSMEETTHEREQUIREMENTSTHEFORTYTHIRDMANUFACTURINGENTERPRISESSHALLCOMPLETETHEWHOLEPROCESSOFTHEPRODUCTREALIZATIONBEFORERELEASINGTHEPRODUCTAPRODUCTIONENTERPRISESHALLSTIPULATETHEPROCEDURES,CONDITIONSANDAPPROVALOFRELEASEOFTHEPRODUCTS,ANDSHALLKEEPTHEEVIDENCETHATTHEPRODUCTSMEETTHEREQUIREMENTSANDRECORDTHEPERSONNELWHOHAVETHERIGHTTORELEASETHEPRODUCTSTHERELEASEDPRODUCTSHALLBEACCOMPANIEDBYACERTIFICATEOFCONFORMITYTHEFORTYFOURTHMANUFACTURINGENTERPRISESSHALLESTABLISHFEEDBACKPROCEDURESANDFORMDOCUMENTSTOMONITORWHETHERTHEINFORMATIONHASBEENMET,ANDTODETERMINETHEMETHODSFOROBTAININGANDUTILIZINGSUCHINFORMATIONFORTYFIFTHPRODUCTIONENTERPRISESSHALLESTABLISHINTERNALAUDITPROCEDUREQUALITYMANAGEMENTSYSTEMDOCUMENTANDPROVISIONSOFTHEAUDITCRITERIA,SCOPE,FREQUENCY,PARTICIPANTS,METHODS,REQUIREMENTSANDCORRECTEVALUATIONRECORDSOFMEASURESOFEFFECTIVENESS,TODETERMINEWHETHERTHEQUALITYMANAGEMENTSYSTEMINACCORDANCEWITHTHEREQUIREMENTSOFTHISSPECIFICATIONANDTHEEFFECTIVEIMPLEMENTATIONOFTHENINTHCHAPTERSALESANDSERVICEFORTYSIXTHPRODUCTIONENTERPRISESSHALLREVIEWANDMAINTAINRECORDSOFREQUIREMENTSRELATEDTOTHEPRODUCT,MAKEPROVISIONSTODETERMINETHEPRODUCTREQUIREMENTSANDFORMDOCUMENTS,SUCHASCONTRACTS,TENDERS,ORDERSORPRODUCTINFORMATION,TOENSURETHATTHEPRODUCTIONENTERPRISESHAVETHEABILITYTOMEETTHESEREQUIREMENTSIFTHEPRODUCTREQUIREMENTSCHANGE,SHOULDREVIEWANDMAINTAINTHEREVIEWRECORD,MODIFYTHERELEVANTDOCUMENTSANDNOTIFYTHERELEVANTPERSONNELARTICLEFORTYSEVENTHIFTHEPROVISIONSOFTHISARTICLEAPPLY,THEMANUFACTURINGENTERPRISESHALLDETERMINETHEMEDICALEQUIPMENTINSTALLATIONREQUIREMENTSANDINSTALLATIONVERIFICATIONACCEPTANCECRITERIAANDFORMDOCUMENTSWHENTHESTAFFMEDICALEQUIPMENTINSTALLATIONACTIVITIESBYOUTSIDEPRODUCTIONENTERPRISEORITSAUTHORIZEDAGENT,PRODUCTIONENTERPRISESSHALLPROVIDEINSTALLATIONANDVERIFICATIONREQUIREMENTSDOCUMENTS,ANDTAKEAPPROPRIATECONTROLMEASURESFORTHEINSTALLATIONANDVALIDATIONACTIVITIESTHEMANUFACTURINGENTERPRISESHALLMAINTAINTHEINSTALLATIONANDVERIFICATIONRECORDSCOMPLETEDBYORBYITSAUTHORIZEDAGENTINTHECASEOFSERVICEREQUIREMENTS,THEFORTYEIGHTHMANUFACTURINGENTERPRISESSHALLSTIPULATETHESERVICEACTIVITIESANDTHEIRREQUIREMENTSFORVERIFICATION,ANDKEEPTHERECORDSOFTHESERVICEACTIVITIESPERFORMEDFORTYNINTHPRODUCTIONENTERPRISESTOCHOOSEMEDICALEQUIPMENTBUSINESSENTERPRISE,SHOULDCOMPLYWITHMEDICALEQUIPMENTRELATEDLAWSANDREGULATIONSREQUIREMENTSFIFTIETHPRODUCTIONENTERPRISESSHALLESTABLISHANDMAINTAINSALESRECORDS,ACCORDINGTOSALESRECORDSSHOULDBEABLETOTRACKDOWNTHESALEOFEACHBATCHOFPRODUCTSTHETENTHCHAPTERNONCONFORMINGPRODUCTCONTROLFIFTYFIRSTPRODUCTIONENTERPRISESSHALLESTABLISHCONTROLPROCEDURESFORNONCONFORMINGPRODUCTSANDFORMDOCUMENTSTHATPROVIDEFORTHEFUNCTIONSANDPOWERSOFDEPARTMENTSANDPERSONNELWHOHAVECONTROLOVERNONCONFORMINGPRODUCTSFIFTYSECONDPRODUCTIONENTERPRISESSHALLIDENTIFY,RECORD,ISOLATEANDREVIEWTHENONCONFORMINGPRODUCTS,ANDADOPTCORRESPONDINGDISPOSALMETHODSFORNONCONFORMINGPRODUCTSACCORDINGTOTHERESULTSOFTHEEVALUATIONARTICLEFIFTYTHIRDWHENTHEPRODUCTISDELIVEREDORSTARTEDTOBEUSED,THEPRODUCTIONENTERPRISESHALLTAKECORRESPONDINGMEASURESWHENTHEPRODUCTISFOUNDTOBEUNQUALIFIEDFIFTYFOURTH,IFTHEPRODUCTNEEDSTOBEREWORKED,THEREWORKDOCUMENTSSHALLBEPREPARED,INCLUDINGTHEWORKINSTRUCTIONSANDTHEREEXAMINATIONANDREEVALUATIONOFNONCONFORMINGPRODUCTSAFTERREWORK,ANDSHALLBEAPPROVEDPRIORTOAPPROVALOFREWORKDOCUMENTS,THEADVERSEEFFECTSOFREWORKONTHEPRODUCTSHALLBEDETERMINEDTHEELEVENTHCHAPTERISCUSTOMERCOMPLAINTANDADVERSEEVENTMONITORINGFIFTYFIFTHPRODUCTIONENTERPRISESSHALLDESIGNATERELEVANTDEPARTMENTSTORECEIVE,INVESTIGATE,EVALUATEANDHANDLECUSTOMERCOMPLAINTSANDKEEPRECORDSFIFTYSIXTHPRODUCTIONENTERPRISESSHALLSETUPADVISORYNOTICES,PUBLISHANDIMPLEMENTPROCEDURES,ANDFORMDOCUMENTSTOKEEPRECORDSOFRELEASEANDIMPLEMENTATIONFIFTYSEVENTHPRODUCTIONENTERPRISESSHALLBEINACCORDANCEWITHTHEMEDICALDEVICEADVERSEEVENTMONITORINGANDREEVALUATIONMANAGEMENTREQUIRESTHEESTABLISHMENTOFADVERSEEVENTMONITORINGPROGRAMANDDOCUMENTMANAGEMENTFUNCTIONS,CLEARADVERSEEVENTS,ADVERSEEVENTSSPECIFIEDCOLLECTIONMETHODS,PRINCIPLES,PROCEDURESANDTIMELIMITOFREPORTREPORTFIFTYEIGHTHPRODUCTIONENTERPRISESSHALLMAINTAINRECORDSOFTHEMONITORINGANDREEVALUATIONOFMEDICALDEVICEADVERSEEVENTS,ANDESTABLISHRELEVANTARCHIVESTHETWELFTHCHAPTERISANALYSISAN