医疗器械注册管理办法英文四号令.docx

医疗器械注册管理办法英文四号令.docx

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医疗器械注册管理办法英文四号令

ProvisionsforMedicalDeviceRegistration

ChapterIGeneralProvisions

Article1

TheProvisionsareformulatedinaccordancewiththeRegulationsfortheSupervisionandAdministrationofMedicalDeviceswithaviewtostandardizingtheregistrationandfilingadministrationofmedicaldeviceandguaranteethesafetyandeffectivenessofmedicaldevices.

Article2

AllmedicaldevicessoldandusedwithintheterritoryofthePeople'sRepublicofChinashallcomplywiththeProvisionstoapplyforregistrationorconductfiling.

Article3

Medicaldeviceregistrationreferstoapprovalprocessconductedbythefoodanddrugregulatoryauthorityuponanapplicationsubmittedbytheregistrationapplicant,followsthelegalproceduretodecidewhetherthemedicaldevicetobemarkedcanbeapprovedornotbasedonacomprehensiveassessmentonresearchanditsresultofmedicaldevice’ssafetyandeffectiveness.

Medicaldevicefilingreferstothefoodanddrugregulatoryauthorityfilesfilingmaterialssubmittedbythefilingapplicantforfuturereference.

Article4

Registrationandfilingshallfollowtheprincipleofpublicity,justice,andequity.

Article5

FilingadministrationshallbeimplementedforClassImedicaldevices.RegistrationadministrationshallbeimplementedforClassIIandClassIIImedicaldevices.

FilingforClassIdomesticmedicaldevice,thefilingapplicantshallsubmitthefilingtothefoodanddrugregulatoryauthorityofthemunicipalityconsistingofdistricts.

ClassIIdomesticmedicaldevicesshallbeinspectedbythefoodanddrugregulatoryauthorityoftheprovinces,autonomousregions,municipalitiesdirectlyunderthecentralgovernment,andtheRegistrationCertificateforMedicalDevicewillbegrantedafterapproval.

ClassIIIdomesticmedicaldevicesshallbeinspectedbytheChinaFoodandDrugAdministration（hereinafterreferredtoasCFDA）,andtheRegistrationCertificateforMedicalDevicewillbegrantedafterapproval.

FilingforClassIimportedmedicaldevice,thefilingapplicantshallsubmitthefilingtoCFDA.

ClassIIandClassIIIimportedmedicaldevicesshallbeinspectedbytheCFDA,andtheRegistrationCertificateforMedicalDevicewillbegrantedafterapproval.

ThemedicaldevicesfromHongKong,MacauandTaiwanshallberegisteredorfiledrefertotheimportedmedicaldevices.

Article6

Theregistrationapplicantandfilingapplicantshalllaunchproducttothemarketinitsownnameandholdlegalliabilityfortheproduct.

Article7

Thefoodanddrugregulatoryauthorityshallpublicizeinformationofmedicaldeviceregistrationandfilingaccordingtotheregulations.Theapplicantcaninquirytheapprovalprocessandresults,thepubliccanlookupapprovalresults.

Article8

Chinaencouragesresearchanddevelopmentandinnovationofmedicaldevices,conductsspecialapprovalproceduresforinnovativemedicaldevices,contributestopromotionandapplicationfornewtechnologyofmedicaldevicesandbooststhedevelopmentofmedicaldeviceindustry.

ChapterIIBasicRequirement

Article9

TheapplicantorthefilingapplicantshallestablishqualitymanagementsystemrelatedtoR&Dandmanufactureofproduct,implementitandkeepitoperateseffectively.

Fordomesticproductsapprovedbythespecialapprovalproceduresforinnovativemedicaldeviceapplyfortheregistrationapplicationandsamplesentrustedothermanufacturerstoproduce,theentrustedmanufacturersshallhavecorrespondingmanufacturingscope;fordomesticproductsnotapprovedbythespecialapprovalproceduresforinnovativemedicaldeviceapplyforregistrationapplication,theirsamplescannotentrustothermanufacturerstoproduce.

Article10

Thepersonthatapplyforregistrationorconductfilingformedicaldeviceshallhavethecorrespondingprofessionalknowledgeandbefamiliarwithlaws,regulations,normativedocumentsandtechnicalrequirementsregardingtomedicaldeviceregistrationorfilingadministration.

Article11

Theapplicantsorthefilingapplicantsshallfollowthebasicrequirementforsafetyandeffectivenessofmedicaldevice,ensureR&Dprocessarebeingtruthfulandstandardized,andallthedataistrue,completeandtraceablewhentheyconductfilingorapplyforregistration.

Article12

ThematerialsforregistrationapplicationshalluseChinese.Whentheapplicationdocumentsaretranslatedfromaforeignlanguage,theoriginaldocumentsshallalsobeprovidedatthesametime.Whenreferringtounpublishedliterature,theapplicantshallprovideevidenceofowner’spermissiontousetheinformation.

Theapplicantshalltakefullyresponsibilityfortheauthenticityoftheregistrationapplicationdocuments.

Article13

Forimportedmedicaldeviceintendedtoapplyforregistrationorconductfiling,theapplicantorthefilingapplicantshallgetmarketclearanceofthecountryorregionwheretheirregistrationormanufacturingplacelocatedforthemedicaldevice.

Ifcountryorregionwheretheapplicant’sorthefilingapplicant’sregistrationormanufacturingplaceslocateddoesnotadministertheproductsasmedicaldevice,theapplicantorthefilingapplicantshallproviderelevantsupportingdocuments,includingtheapprovaloflegalsalesissuedbythecountryorregionwheretheirregistrationormanufacturingplacelocated.

Article14

TheoverseasapplicantorthefilingapplicantshallconductrelevantbusinessthroughtheirrepresentativeofficelocatedwithintheterritoryofChinaordesignateanenterpriselocatedwithintheterritoryofChinaasagent.

Besidesconductregistrationandfilingrelatedwork,theagentshallbeliablefor:

（1）Contactwithcorrespondingfoodanddrugregulatoryauthorityandtheoverseasapplicantorthefilingapplicant;

（2）Deliverrelatedlaws,regulationsandtechnicalrequirementtotheapplicantorthefilingapplicanttrulyandfaithfully;

（3）Collectpost-marketadverseeventinformationofmedicaldevicesandfeedbacktotheoverseasapplicantorthefilingapplicant,meanwhile,reporttorelevantfoodanddrugregulatoryauthority;

（4）Collaboratetherecallforpost-marketmedicaldevices,andreporttorelevantfoodanddrugregulatoryauthority;

（5）Undertakeotherjointliabilitiesrelatedtoproductqualityandafter-salesservice.

ChapterIIIProducttechnicalrequirementandRegistrationTesting

Article15

Theapplicantorthefilingapplicantshallpreparetheproducttechnicalrequirementofthemedicaldevicetoberegisteredorfiled.TheproducttechnicalrequirementofClassImedicaldeviceshallbesubmittedtothefoodanddrugauthoritiesduringtheapplicantconductsfiling.TheproducttechnicalrequirementofClassIIorClassIIImedicaldevicesshallbecheckedandapprovedbythefoodanddrugauthoritiesatthetimeofregistrationapproval.

Theproducttechnicalrequirementmainlyincludestheperformanceindicesandtestingmethodofthecompletedmedicaldevice,andtheperformanceindicesrefertotheobjectivedeterminationofproductfunctionality,securityindexandotherindicatorsofqualitycontrol.

ThemedicaldevicelaunchedinChinashallcomplywithitsproducttechnicalrequirementwhichwascheckedandapprovedforregistrationorfiledalready.

Article16

TheregistrationtestingshallbeconductedtoapplyregistrationforClassIIandClassIIImedicaldevice.Thetestinginstitutesofmedicaldeviceshallconductregistrationtestingaccordingtoproducttechnicalrequirement.

Themanufactureofsamplesforregistrationtestingshallcomplywithrelatedrequirementsofqualitymanagementsystem;productstestedtobequalifiedinregistrationtestingcanbeusedforclinicaltrialorregistrationapplication.

Thefilingapplicantcansubmitself-testingreportoftheproducttoconductfiling.

Article17

Toapplyforregistrationtesting,theapplicantshallprovidesamples,producttechnicalrequirementandothertechnicalmaterialsrequiredbytheregistrationtestingtothetestinginstitutes.

Article18

Testinginstitutesofmedicaldeviceshallhavecertainqualifications,performtestingwithintheirspecifiedtestingscopeandconductpre-evaluationontheproducttechnicalrequirement.Thetestinginstitutesshallissuethepre-evaluationopinionsandtheregistrationtestingreportofmedicaldevicetogethertotheapplicant.

Forthemedicaldevicesthathavenotbeenincludedintestingscopeofanymedicaldevicetestinginstitutes,therelatedregistrationauthorityshalldesignateacapabletestinginstitutetoconductthetesting.

Article19

Thetestingproductsinasameregistrationunitshallrepresentthesafetyandeffectivenessoftherestproductsinthisregistrationunit.

ChapterIVClinicalEvaluation

Article20

Clinicalevaluationofmedicaldevicereferstotheprocessthattheapplicantorthefilingapplicantvalidateswhetheraproductcanmeettheoperatingrequirementsorscopeofapplicationornotthroughclinicalliterature,clinicalpracticedata,clinicaltrialandotherinformation.

Article21

Clinicalevaluationmaterialsrefertothedocumentsformedbytheapplicantorthefilingapplicantduringtheclinicalevaluation.

Forthoserequiredclinicaltrial,theclinicalevaluationmaterialstobesubmittedshallincludetheprotocolandthereportofclinicaltrial.

Article22

ItisnotnecessarytoconductclinicaltrialforfilingClassImedicaldevices.ItisnecessarytoconductclinicaltrialforregistrationapplicationofClassIIandClassIIImedicaldevices;however,inanyofthefollowingcircumstances,theclinicaltrialcouldbeexempted.

（1）Withdefiniteoperatingprinciple,establisheddesign,maturemanufactureprocess;norecordforseriousadverseeventofsub