医疗器械监督管理条例第650令英文翻译版本剖析Word文件下载.docx

医疗器械监督管理条例第650令英文翻译版本剖析Word文件下载.docx

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DecreeoftheStateCouncilofthePeople’sRepublicofChina

No.650

TheRegulationsfortheSupervisionandManagementofMedicalDevices,revisedatthe39thexecutivemeetingoftheStataCouncilonFebruary12,2014,isherebypromulgatedandshallgointoeffectasofJune1,2014.

Premier:

LiKeqiang

March7,2014

（PromulgatedastheDecreeoftheStateCouncilofthePeople’sRepublicofChinaNo.276onJanuary4,2000,andrevisedatthe39thexecutivemeetingoftheStataCouncilonFebruary12,2014.）

ChapterIGeneralProvisions

Article1TheRegulationsareherebyformulatedwithaviewtoguaranteeingthesafetyandeffectivenessofmedicaldevicesandprotectinghumanhealthandlifesafety.

Article2Allunitsorindividualsengagedintheresearchanddevelopment,production,distribution,use,supervisionandmanagementofmedicaldeviceswithintheterritoryofthePeople'

sRepublicofChinashallcomplywiththeRegulation.

Article3ThefoodanddrugsupervisionandmanagementdepartmentoftheStateCouncilshallberesponsibleforthesupervisionandmanagementofnationalmedicaldevices.RelevantdepartmentsoftheStateCouncilshallberesponsibleforthesupervisionandmanagementrelatingtomedicaldeviceswithinrespectivetermofreference.

Thefoodanddrugsupervisionandmanagementdepartmentofthelocalpeople’sgovernmentabovethelevelofcountyshallberesponsibleforthesupervisionandmanagementofmedicaldeviceswithinrespectiveadministrativeregion.Relevantdepartmentsofthelocalpeople’sgovernmentsabovethelevelofcountyshallberesponsibleforthesupervisionandmanagementrelatingtomedicaldeviceswithinrespectivetermofreference.

ThefoodanddrugsupervisionandmanagementdepartmentoftheStateCouncilshallsupporttherelevantdepartmentsoftheStateCouncilintheimplementationofthenationalindustrialplansandpoliciesonmedicaldevices.

Article4TheStateshallimplementclassifiedmanagementonmedicaldevicesbasedonthedegreeofrisk.

ClassIMedicalDevicesarethosewithlowerdegreeofriskforwhichthesafetyandeffectivenesscanbeensuredthroughroutinemanagement;

ClassIIMedicalDevicesarethosewithmediumdegreeofriskforwhichfurthercontrolisrequiredtoensuretheirsafetyandeffectiveness

ClassIIIMedicalDevicesarethosewithhigherdegreeofriskwhichmustbestrictlycontrolledinrespecttosafetyandeffectiveness.

Evaluationondegreeofriskshouldtakeintoaccounttheanticipatedpurpose,structuralcharacteristics,usage,andotherfactorsofmedicaldevices.

ThefoodanddrugsupervisionandmanagementdepartmentoftheStateCouncilshallberesponsibleforformulatingtheclassificationrulesandclassifiedcatalogofmedicaldevices,conducttimelyanalysisandevaluationonthechangeofproductriskaccordingtotheproduction,distribution,anduseofthemedicaldevices,andadjustclassifiedcatalog.Whenformulatingandadjustingtheclassifiedcatalog,thefoodanddrugsupervisionandmanagementdepartmentoftheStateCouncilshallfullylistentotheopinionsofthemedicaldevicemanufacturingandoperatingenterprises,usingunits,andindustrialorganizations,andconsultinginternationalclassificationpracticesofmedicaldevices.Theclassifiedcatalogshouldbemadepublic.

Article5TheR&

Dofmedicaldevicesshallbebasedontheprincipleofsafety,effectivenessandpracticingeconomy.TheStatewhilegivingplaytotheroleofmarketmechanismencouragestheresearchanddevelopmentandinnovationofmedicaldevices,booststheapplicationandgeneralizationofnewtechnologyofmedicaldevices,andpromotesthedevelopmentofmedicaldeviceindustry.

Article6Medicaldeviceproductsshallcomplywiththecompulsorynationalstandardformedicaldevices;

ifthecompulsorynationalstandardisunavailable;

complywiththecompulsoryindustrialstandardformedicaldevices.

Thecatalogofdisposablemedicaldevicesshallbeformulated,adjustedandpublishedbythefoodanddrugsupervisionandmanagementdepartmentoftheStateCounciltogetherwiththecompetenthealthandfamilyplanningdepartmentoftheStateCouncil.Medicaldevicesthatcanguaranteeitssafetyandeffectivenesswhenreusedshallnotbeincludedinthecatalog.Formedicaldevicesthatcanguaranteeitssafetyandeffectivenesswhenreusedafterimprovementsinitsdesign,productionprocessandsterilizationtechnology,etc.,theyshallberuledoutfromthecatalog.

Article7Themedicaldevicesindustrialorganizationshouldstrengthenindustrialself-discipline,promotecreditsystemconstruction,urgeenterprisestoconductproductionandoperationactivitiesaccordingtolaw,andguideenterpr