医疗器械监督管理条例英文.docx
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医疗器械监督管理条例英文
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。
Possessfacili
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