医疗器械监督管理条例英文文档格式.docx
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医疗器械监督管理条例英文文档格式.docx
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RegulationsfortheSupervisionandAdministrationofMedicalDevices
RegulationsfortheSupervisionandAdministrationofMedicalDevices
ChapterIGeneralProvisions
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.
Article4ThedrugregulatoryauthorityundertheStateCouncilisresponsibleforsupervisionandadministrationofmedicaldevicesnationwide.Thedrugadministrationofthelocalgovernmentatcountylevelandaboveisresponsibleforsupervisionandadministrationofmedicaldevicesineachadministrativeregion.ThedrugregulatoryauthorityundertheStateCouncilshallcoordinatewithotherdepartmentsundertheStateCouncil,responsibleforcomprehensiveeconomicadministration,intheimplementationofpoliciesforthemedicaldeviceindustry.
Article5TheStateshallclassifymedicaldevicesandadministerthembasedonthisclassification
ClassIMedicalDevicesarethoseforwhichsafetyandeffectivenesscanbeensuredthroughroutineadministration;
ClassIIMedicalDevicesarethoseforwhichfurthercontrolisrequiredtoensuretheirsafetyandeffectiveness
ClassIIIMedicalDevicesarethosewhichareimplantedintothehumanbody,orusedforlifesupportorsustenance,orposepotentialrisktothehumanbodyandthusmustbestrictlycontrolledinrespecttosafetyandeffectiveness.
Theclassificationcatalogueformedicaldevicesshallbestipulated,adjustedandpromulgatedbythedrugregulatoryauthorityundertheStateCouncil,inaccordancewithclassificationprinciplesafterconsultingwithhealthauthorityundertheStateCouncil.
Article6Medicaldevicesproducedandusedforthepurposeofprovidingconcretemeasuringvaluesshallcomplywiththerequirementsofthemeteringlaw.ThedetailedproductlistshallbeformulatedandpromulgatedbythedrugregulatoryauthorityundertheStateCouncil,jointlywiththemeteringauthority.
ChapterIITheAdministrationofMedicalDevices
Article7TheStateencouragestheresearchanddevelopmentofnewmedicaldevices."
Newmedicaldevices"
refertothekindofbrandnewproductvarietieswhichhavenotbeenavailableinthedomesticmarket,orforwhichthesafety,effectivenessandproductmechanismhavenotbeenrecognizeddomestically.
TheclinicaltrialsofnewmedicaldevicesofClassIIandClassIIIcanbeconductedonlyafterclinicaltrialapprovalbytherelevantauthorityinaccordancewiththerulesofthedrugregulatoryauthorityunderStateCouncil.
NewmedicaldevicesthathavecompletedclinicaltrialsandpassedexpertsevaluationandrevieworganizedbythedrugregulatoryauthorityunderStateCouncil,shallreceiveanewproductcertificateafterbeingapprovedbythesameorganization.
Article8TheStateshallimplementaproductregistrationsystemforthemanufacturingofmedicaldevices.
ClassImedicaldevicesshallbeinspected,approvedandgrantedwitharegistrationcertificatebythedrugregulatoryauthorityofthegovernmentofthemunicipalitiesconsistingofdistricts.
ClassIImedicaldevicesshallbeinspected,approvedandgrantedwithregistrationcertificatesbythedrugregulatoryauthoritiesofprovinces,autonomousregionsandmunicipalitiesdirectlyunderthecentralgovernment.
ClassIIImedicaldevicesshallbeinspected,approvedandgrantedwithregistrationcertificatesbythedrugregulatoryauthoritydirectlyundertheStateCouncil.
ClinicalevaluationmustbeconductedforClassIIandClassIIImedicaldevicesbeforetheyareputintoproduction.
Article9Thedrugregulatoryauthoritiesofprovinces,autonomousregionsandmunicipalitiesdirectlyunderthecentralgovernmentareresponsiblefortheinspectionandapp
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