医疗器械监督管理系统条例第650令英文翻译版本.docx

医疗器械监督管理系统条例第650令英文翻译版本.docx

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医疗器械监督管理系统条例第650令英文翻译版本

RegulationsfortheSupervisionandManagementofMedicalDevices

DecreeoftheStateCouncilofthePeople’sRepublicofChina

No.650

TheRegulationsfortheSupervisionandManagementofMedicalDevices,revisedatthe39thexecutivemeetingoftheStataCouncilonFebruary12,2014,isherebypromulgatedandshallgointoeffectasofJune1,2014.

Premier:

LiKeqiang

March7,2014

RegulationsfortheSupervisionandManagementofMedicalDevices

（PromulgatedastheDecreeoftheStateCouncilofthePeople’sRepublicofChinaNo.276onJanuary4,2000,andrevisedatthe39thexecutivemeetingoftheStataCouncilonFebruary12,2014.）

ChapterIGeneralProvisions

Article1TheRegulationsareherebyformulatedwithaviewtoguaranteeingthesafetyandeffectivenessofmedicaldevicesandprotectinghumanhealthandlifesafety.

Article2Allunitsorindividualsengagedintheresearchanddevelopment,production,distribution,use,supervisionandmanagementofmedicaldeviceswithintheterritoryofthePeople'sRepublicofChinashallcomplywiththeRegulation.

Article3ThefoodanddrugsupervisionandmanagementdepartmentoftheStateCouncilshallberesponsibleforthesupervisionandmanagementofnationalmedicaldevices.RelevantdepartmentsoftheStateCouncilshallberesponsibleforthesupervisionandmanagementrelatingtomedicaldeviceswithinrespectivetermofreference.

Thefoodanddrugsupervisionandmanagementdepartmentofthelocalpeople’sgovernmentabovethelevelofcountyshallberesponsibleforthesupervisionandmanagementofmedicaldeviceswithinrespectiveadministrativeregion.Relevantdepartmentsofthelocalpeople’sgovernmentsabovethelevelofcountyshallberesponsibleforthesupervisionandmanagementrelatingtomedicaldeviceswithinrespectivetermofreference.

ThefoodanddrugsupervisionandmanagementdepartmentoftheStateCouncilshallsupporttherelevantdepartmentsoftheStateCouncilintheimplementationofthenationalindustrialplansandpoliciesonmedicaldevices.

Article4TheStateshallimplementclassifiedmanagementonmedicaldevicesbasedonthedegreeofrisk.

ClassIMedicalDevicesarethosewithlowerdegreeofriskforwhichthesafetyandeffectivenesscanbeensuredthroughroutinemanagement;

ClassIIMedicalDevicesarethosewithmediumdegreeofriskforwhichfurthercontrolisrequiredtoensuretheirsafetyandeffectiveness

ClassIIIMedicalDevicesarethosewithhigherdegreeofriskwhichmustbestrictlycontrolledinrespecttosafetyandeffectiveness.

Evaluationondegreeofriskshouldtakeintoaccounttheanticipatedpurpose,structuralcharacteristics,usage,andotherfactorsofmedicaldevices.

ThefoodanddrugsupervisionandmanagementdepartmentoftheStateCouncilshallberesponsibleforformulatingtheclassificationrulesandclassifiedcatalogofmedicaldevices,conducttimelyanalysisandevaluationonthechangeofproductriskaccordingtotheproduction,distribution,anduseofthemedicaldevices,andadjustclassifiedcatalog.Whenformulatingandadjustingtheclassifiedcatalog,thefoodanddrugsupervisionandmanagementdepartmentoftheStateCouncilshallfullylistentotheopinionsofthemedicaldevicemanufacturingandoperatingenterprises,usingunits,andindustrialorganizations,andconsultinginternationalclassificationpracticesofmedicaldevices.Theclassifiedcatalogshouldbemadepublic.

Article5TheR&Dofmedicaldevicesshallbebasedontheprincipleofsafety,effectivenessandpracticingeconomy.TheStatewhilegivingplaytotheroleofmarketmechanismencouragestheresearchanddevelopmentandinnovationofmedicaldevices,booststheapplicationandgeneralizationofnewtechnologyofmedicaldevices,andpromotesthedevelopmentofmedicaldeviceindustry.

Article6Medicaldeviceproductsshallcomplywiththecompulsorynationalstandardformedicaldevices;ifthecompulsorynationalstandardisunavailable;complywiththecompulsoryindustrialstandardformedicaldevices.

Thecatalogofdisposablemedicaldevicesshallbeformulated,adjustedandpublishedbythefoodanddrugsupervisionandmanagementdepartmentoftheStateCounciltogetherwiththecompetenthealthandfamilyplanningdepartmentoftheStateCouncil.Medicaldevicesthatcanguaranteeitssafetyandeffectivenesswhenreusedshallnotbeincludedinthecatalog.Formedicaldevicesthatcanguaranteeitssafetyandeffectivenesswhenreusedafterimprovementsinitsdesign,productionprocessandsterilizationtechnology,etc.,theyshallberuledoutfromthecatalog.

Article7Themedicaldevicesindustrialorganizationshouldstrengthenindustrialself-discipline,promotecreditsystemconstruction,urgeenterprisestoconductproductionandoperationactivitiesaccordingtolaw,andguideenterprisestobehonestandtrustworthy.

ChapterIIRegistrationandFilingofMedicalDeviceProducts

Article8ProductfilingmanagementshallbeimplementedonClassImedicaldevices.ProductregistrationmanagementshallbeimplementedonClassIIandClassIIImedicaldevices.

Article9ThefollowingmaterialsshouldbesubmittedforthefilingofClassImedicaldeviceproductsandapplicationfortheregistrationofClassIIandClassIIImedicaldeviceproducts.

（I）Productriskanalysismaterials;

（II）Producttechnicalrequirements;

（III）Productinspectionreport;

（IV）Clinicalevaluationmaterials;

（V）Productinstructionandlabelsample;

（VI）Qualitymanagementsystemdocumentsrelatedtoproductresearch&manufactureandproduction;

（VII）Othermaterialsnecessaryfordemonstratingthesafetyandeffectivenessofthemedicaldevice.

Theregistrationapplicantandfilingapplicantofmedicaldevicesshallberesponsiblefortheauthenticityofthematerialssubmitted.

Article10ForthefilingofClassImedicaldeviceproduct,thefilingapplicantshallsubmitfilingmaterialstothefoodanddrugsupervisionandmanagementdepartmentofthepeople’sgovernmentofthemunicipalityestablishedwithdistricts;inwhich,productinspectionreportmaybetheself-inspectionreportofthefilingapplicant;clinicalevaluationmaterialsexcludeclinicaltrialreportbutmaybethematerialsdemonstratingthesafetyandeffectivenessthroughreferencesandthedataobtainedfromtheclinicalapplicationofsimilarproducts.

TheoverseasmanufacturingenterpriseexportingClassImedicaldevicetotheterritoryofthePeople’sRepublicofChinashall,throughitsrepresentativeofficeestablishedwithintheterritoryofthePeople’sRepublicofChinaorthebusinessentitydesignatedwithintheterritoryofthePeople’sRepublicofChinaastheagent,submitfilingmaterialsandtheevidentialdocumentsapprovedbythecompetentdepartmentofthecounty（region）wherethefilingapplicantislocatedformarketingofthemedicaldevicetothefoodanddrugsupervisionandmanagementdepartmentoftheStateCouncil.

Incaseofanychangetothemattersspecifiedinthefilingmaterials,filingapplicantshouldapplyforthefilingofchangewiththeoriginalfilingdepartment.

Article11FortheapplicationfortheregistrationofClassIImedicaldeviceproducts,registrationapplicantshouldsubmitregistrationmaterialstothefoodanddrugsupervisionandmanagementdepartmentofthepeople’sgovernmentoftheprovince,autonomousregion,ormunicipalitydirectlyunderthecentralgovernmentwheretheapplicantislocated.FortheapplicationforregistrationofClassIIImedicaldeviceproducts,registrationapplicantshouldsubmitregistrationmaterialstothefoodanddrugsupervisionandmanagementdepartmentoftheStateCouncil.

OverseasmanufacturingenterpriseexportingClassIIandClassIIImedicaldevicestotheterritoryofthePeople’sRepublicofChina,shouldthroughitsrepresentativeofficeestablishedwithintheterritoryofthePeople’sRepublicofChinaorthebusinessentitydesignatedwithintheterritoryofthePeople’sRepublicofChinaasitsagent,submitregistrationmaterialsandtheevidentialdocumentsapprovedbythecompetentdepartmentofthecounty（region）wheretheregistrationapplicantislocatedformarketingofthemedicaldevicetothefoodanddrugsupervisionandmanagementdepartmentoftheStateCouncil.

TheproductinspectionreportintheregistrationmaterialsofClassIandClassIImedicaldeviceproductsshouldbetheinspectionreportissuedbymedicaldeviceinspectionagency;clinicalevaluationmaterialsshouldincludeclinicaltrialreport,exceptforthemedicaldevicesexemptedfromclinicaltrialaccordingtotheArticle17inthisRegulation.

Article12Thefoodanddrugsupervisionandmanagementdepartmentacceptingregistrationapplicationshallputforwardtheapplicationmaterialstotechnicalevaluationinstitutionwithin3workingdaysafterthedateofacceptance.Technicalevaluationinstitutionshouldcompletethetechnicalevaluationandthensubmitevaluationopiniontothefoodanddrugsupervisionandmanagementdepartment.

Article13Thefoodanddrugsupervisionandmanagementdepartmentacceptingregistrationapplicationshouldmakedecisionwithin20workingdaysafterreceivingtheevaluationopinion.Forthosecomplyingwiththerequirementsonsafetyandeffectiveness,registrationisapprovedandtheMedicalDeviceRegistrationCertificateshallbeissued;forthosenotcomplyingwiththerequirements,theregistrationshallnotbeapprovedandthereasonsshallbespecifiedinwritten.

WhenthefoodanddrugsupervisionandmanagementdepartmentoftheStateCouncilorganizesthetechnicalevaluationonimportedmedicaldevices,ifitdeemsnecessarytoinspectthequalitymanagementsystem,thefood