医疗器械监督管理条例英文Word格式文档下载.docx

医疗器械监督管理条例英文Word格式文档下载.docx

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GeneralProvisions

Article1TheseRegulationsareherebyformulatedwithaviewtostrengtheningthesupervisionandadministrationofmedicaldevices,ensuringtheirsafetyandeffectivenessandprotectinghumanhealthandlifesafety.

Article2Allunitsorindividualsengagedintheresearchanddevelopment,production,distribution,use,supervisionandadministrationofmedicaldeviceswithintheterritoryofthePeoplesRepublicofChinashallcomplywiththeRegulation.

Article3 

"

Medicaldevices"

asdefinedbytheseregulationsrefersto:

anyinstrument,apparatus,appliance,material,orotherarticlewhetherusedaloneorincombination,includingthesoftwarenecessaryforitsproperapplication.Itdoesnotachieveitsprincipalactioninoronthehumanbodybymeansofpharmacology,immunologyormetabolism,butwhichmaybeassistedinitsfunctionbysuchmeans;

theuseofwhichistoachievethefollowingintendedobjectives:

1.Diagnosis,prevention,monitoring,treatmentoralleviationofdisease;

2.Diagnosis,monitoring,treatment,alleviationoforcompensationforaninjuryorhandicapconditions;

3.Investigation,replacementormodificationforanatomyoraphysiologicalprocess;

4.Controlofconception.

Article4 

ThedrugregulatoryauthorityundertheStateCouncilisresponsibleforsupervisionandadministrationofmedicaldevicesnationwide.Thedrugadministrationofthelocalgovernmentatcountylevelandaboveisresponsibleforsupervisionandadministrationofmedicaldevicesineachadministrativeregion.ThedrugregulatoryauthorityundertheStateCouncilshallcoordinatewithotherdepartmentsundertheStateCouncil,responsibleforcomprehensiveeconomicadministration,intheimplementationofpoliciesforthemedicaldeviceindustry.

Article5 

TheStateshallclassifymedicaldevicesandadministerthembasedonthisclassification

ClassIMedicalDevicesarethoseforwhichsafetyandeffectivenesscanbeensuredthroughroutineadministration;

ClassIIMedicalDevicesarethoseforwhichfurthercontrolisrequiredtoensuretheirsafetyandeffectiveness

ClassIIIMedicalDevicesarethosewhichareimplantedintothehumanbody,orusedforlifesupportorsustenance,orposepotentialrisktothehumanbodyandthusmustbestrictlycontrolledinrespecttosafetyandeffectiveness.

Theclassificationcatalogueformedicaldevicesshallbestipulated,adjustedandpromulgatedbythedrugregulatoryauthorityundertheStateCouncil,inaccordancewithclassificationprinciplesafterconsultingwithhealthauthorityundertheStateCouncil.

Article6Medicaldevicesproducedandusedforthepurposeofprovidingconcretemeasuringvaluesshallcomplywiththerequirementsofthemeteringlaw.ThedetailedproductlistshallbeformulatedandpromulgatedbythedrugregulatoryauthorityundertheStateCouncil,jointlywiththemeteringauthority.

II 

TheAdministrationofMedicalDevices

Article7TheStateencouragestheresearchanddevelopmentofnewmedicaldevices."

Newmedicaldevices"

refertothekindofbrandnewproductvarietieswhichhavenotbeenavailableinthedomesticmarket,orforwhichthesafety,effectivenessandproductmechanismhavenotbeenrecognizeddomestically.

TheclinicaltrialsofnewmedicaldevicesofClassIIandClassIIIcanbeconductedonlyafterclinicaltrialapprovalbytherelevantauthorityinaccordancewiththerulesofthedrugregulatoryauthorityunderStateCouncil.

NewmedicaldevicesthathavecompletedclinicaltrialsandpassedexpertsevaluationandrevieworganizedbythedrugregulatoryauthorityunderStateCouncil,shallreceiveanewproductcertificateafterbeingapprovedbythesameorganization.

Article8TheStateshallimplementaproductregistrationsystemforthemanufacturingofmedicaldevices.

ClassImedicaldevicesshallbeinspected,approvedandgrantedwitharegistrationcertificatebythedrugregulatoryauthorityofthegovernmentofthemunicipalitiesconsistingofdistricts.

ClassIImedicaldevicesshallbeinspected,approvedandgrantedwithregistrationcertificatesbythedrugregulatoryauthoritiesofprovinces,autonomousregionsandmunicipalitiesdirectlyunderthecentralgovernment.

ClassIIImedicaldevicesshallbeinspected,approvedandgrantedwithregistrationcertificatesbythedrugregulatoryauthoritydirectlyundertheStateCouncil.

ClinicalevaluationmustbeconductedforClassIIandClassIIImedicaldevicesbeforetheyareputintoproduction.

Article9Thedrugregulatoryauthoritiesofprovinces,autonomousregionsandmunicipalitiesdirectlyunderthecentralgovernmentareresponsiblefortheinspectionandapprovaloftheclinicaltrialorverificationofclassIImedicaldevicesintheirownadministrativeregions.ThedrugregulatoryauthorityundertheStateCouncilisresponsiblefortheinspectionandapprovalofclinicaltrialorverificationofclassIIImedicaldevices.

Clinicaltrialorverificationshallbeconductedinthemedicalinstitutionsdesignatedbythedrugregulatoryauthoritiesofthegovernmentatprovinciallevelandabove.Themedicalinstitutionsshallconducttheclinicaltrialorverification,inaccordancewiththerelatedprovisionsofthedrugregulatoryauthorityundertheStateCouncil.

Thequalificationofmedicalinstitutionsengagedintheclinicaltrialorverificationshallbecertifiedbythedrugregulatoryauthority,jointlywiththehealthauthorityundertheStateCouncil.

Article10Medicalinstitutionsmaydevelopmedicaldevicestoservetheirownclinicalneeds,andusethemwithintheirowninstitutionundertheguidanceoflicensedmedicalpractitioners.

ClassIImedicaldevicesdevelopedbymedicalinstitutionsshallbeinspectedandapprovedbythedrugregulatoryauthorityofthegovernmentatprovinciallevelandabove.ClassIIImedicaldevicesdevelopedbymedicalinstitutionsshallbeinspectedandapprovedbythedrugregulatoryauthorityundertheStateCouncil.

Article11WhenimportingmedicaldevicesintoChinaforthefirsttime,theagentoftheimporteddevice,shouldsubmittheinstructionforuse,qualitystandards,testingmethods,otherrelevantinformation,productsamples,andmarketingauthorizationcertificatesissuedbythemanufacturingcountries（regions）,forinspectionandapprovalbythedrugregulatoryauthorityundertheStateCouncil,andreceiveanimportproductregistrationcertificatebeforeapplyingforcustomsformalities.

Article12Whenapplyingforregistrationofmedicaldevices,technicalstandards,testingreportandotherrelevantinformationshallbesubmittedaccordingtoprovisionsofthedrugregulatoryauthorityundertheStateCouncil.

Thedrugregulatoryauthorityofthegovernmentofthemunicipalityconsistingofdistrictsshalldecidewithin30workingdaysiftheproductcanberegistered,countingfromthedateofacceptanceoftheapplication.Forthosenotapprovedforregistration,awrittenexplanationshallbegiventotheapplicant.

Thedrugregulatoryauthorityofgovernmentsofprovinces,autonomousregionsandmunicipalitiesdirectlyundercentralgovernmentshalldecidewithin60workingdaysiftheproductcanberegistered,countingfromthedateofacceptanceoftheapplication.Forthosenotapprovedforregistration,awrittenexplanationshallbegiventotheapplicant.

ThedrugregulatoryauthorityundertheStateCouncilshalldecidewithin90workingdaysiftheproductcanberegistered,countingfromthedateofacceptanceoftheapplication.Forthosenotapprovedforregistration,awrittenexplanationshallbegiventotheapplicant.

Article13 

Incaseanysituationreflectedinthecontentoftheregistrationcertificateischanged,theholderofthecertificateshallapplyforanamendmentofthecertificateaccordingly,orforre-registrationwithin30workingdaysfromthechange.

Article14Thetermofvalidityfortheregistrationcertificateofmedicaldevicesisfouryears.Theholderofthecertificateshallapplyforre-registrationwithinsixmonthsbeforethecertificateexpires.

Whenthemanufacturingofamedicaldeviceisstoppedcontinuouslyformorethan2years,itsregistrationcertificateisautomaticallyinvalidated.

Article15Medicaldevicesmanufacturedshallmeetthenationalstandard,orprofessionalstandardswhentherearenorelevantnationalstandardsavailable.

NationalstandardsofmedicaldevicesshallbeformulatedjointlybythestandardizationauthorityandthedrugregulatoryauthorityundertheStateCouncil.ProfessionalstandardsofmedicaldevicesshallbeformulatedbythedrugregulatoryauthorityundertheStateCouncil.

Article16Theinstructionforuse,labelandpackageofmedicaldevicesshallcomplywithrelevantstandardsorprovisionsinChina.

Article17TheregistrationnumberofamedicaldeviceshallbemarkedontheproductitselfandtheexternalpackageaccordingtotheprovisionsofthedrugregulatoryauthorityundertheStateCouncil.

Article18TheStateimplementsasystemofre-evaluationandobsolescenceformedicaldevices,thedetailsofwhichshallbeformulatedbydrugregulatoryauthorityundertheStateCouncilafterconsultingwithotherrelatedauthoritiesundertheStateCouncil.

III 

AdministrationofProduction,DistributionandUse

ofMedicalDevices

Article19Enterprisesmanufacturingmedicaldevicesshallmeetthefollowingconditions:

1.Possessprofessionaltechnicalpersonnelrequiredforthemanufactureofitsmedicaldevices;

2.Possessfa