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1、RegulationsfortheSupervisionandAdministrationofMedicalDevicesChapter I GeneralProvisionsArticle1TheseRegulationsareherebyformulatedwithaviewtostrengtheningthesupervisionandadministrationofmedicaldevices,ensuringtheirsafetyandeffectivenessandprotectinghumanhealthandlifesafety.Article2Allunitso
2、rindividualsengagedintheresearchanddevelopment,production,distribution,use,supervisionandadministrationofmedicaldeviceswithintheterritoryofthePeople'sRepublicofChinashallcomplywiththeRegulation.Article3 "Medicaldevices"asdefinedbytheseregulationsrefersto:anyinstrument,apparatus,appliance,mate
3、rial,orotherarticlewhetherusedaloneorincombination,includingthesoftwarenecessaryforitsproperapplication.Itdoesnotachieveitsprincipalactioninoronthehumanbodybymeansofpharmacology,immunologyormetabolism,butwhichmaybeassistedinitsfunctionbysuchmeans;theuseofwhichistoachievethefollowingintendedob
4、jectives:1.Diagnosis,prevention,monitoring,treatmentoralleviationofdisease;2.Diagnosis,monitoring,treatment,alleviationoforcompensationforaninjuryorhandicapconditions;3.Investigation,replacementormodificationforanatomyoraphysiologicalprocess;4.Controlofconception.Article4 Thedrugregulatoryaut
5、horityundertheStateCouncilisresponsibleforsupervisionandadministrationofmedicaldevicesnationwide.Thedrugadministrationofthelocalgovernmentatcountylevelandaboveisresponsibleforsupervisionandadministrationofmedicaldevicesineachadministrativeregion.ThedrugregulatoryauthorityundertheStateCouncils
6、hallcoordinatewithotherdepartmentsundertheStateCouncil,responsibleforcomprehensiveeconomicadministration,intheimplementationofpoliciesforthemedicaldeviceindustry.Article5 TheStateshallclassifymedicaldevicesandadministerthembasedonthisclassificationClassIMedicalDevicesarethoseforwhichsafetyand
7、effectivenesscanbeensuredthroughroutineadministration;ClassIIMedicalDevicesarethoseforwhichfurthercontrolisrequiredtoensuretheirsafetyandeffectivenessClassIIIMedicalDevicesarethosewhichareimplantedintothehumanbody,orusedforlifesupportorsusten
