医疗器械监督管理系统条例英文.docx
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医疗器械监督管理系统条例英文.docx
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医疗器械监督管理系统条例英文
Regulations
RegulationsfortheSupervisionandAdministrationofMedicalDevices
RegulationsfortheSupervisionandAdministrationofMedicalDevices
Chapter I 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.
Chapter 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.
Chapter III AdministrationofProduction,DistributionandUse
ofMedicalDevices
Article19Enterprisesmanufacturingmedicaldevicesshallmeetthefollowingconditions:
1.Possessprofessionaltechnicalpersonnelrequiredforthemanufactureofitsmedicaldevices;
2.Possess
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