醫(yī)療器械法規(guī)和管理課件

BIMT,withitsformernameBeijingMedicalDeviceTestingStation,wasestablishedin1983anditwasattachedtotheformerBeijingMedicalEquipmentInstitute.

BIMThasreformedintoapublicinstitutionwithindependentjudicialpersonsince2000,whichwasanaffiliateofBJDA.SametimeItisasubordinateagencyofSFDA.---BriefIntroductionofBIMT---BriefIntroductionofBIMTAsanationalmedicaldevicetestingcenter,BIMTundertakestheassignmentssuchasregistrationtesting,supervisionsamplingtestingofmedicaldevicetesting,CCCcompulsorysafetycertificationtesting,testingofimport&exportcommodities,certificationtesting,entrustedtestingandarbitrationtestinginandoutofChina.

----TestingCapacityImport&ExportRegistrationSupervisionCertificationEntrust…AsanationalmedicaldevicetContent1.PresentsituationofCFDA2.Presentmedicaldeviceregulationssystem3.Presentmedicaldevicestandardssystem3Content1.Presentsituationof4

ControlofalllifecycleProductsregistrationManufacturerapprovedSurveillanceforproducts：suchassamplingtesting,Recall,Adverseevents.Surveillanceforbehaviors(GMP):Suchasqualitysystems,distribution,use,disposalPostmarketBeforemarketMDlifecycle＝R&D－Manufacture－sales－use－service－disposal4Cont

PresentsituationofCFDA5ChinafoodanddrugadministrationDepartmentofMedicalDeviceRegistration

DepartmentofMedicalDevicesupervisionRegistrationI

RegistrationII

GeneralAffairsGeneralAffairsDepartmentofScience,TechnologyandStandardsResearchSupervisionManufacturingSupervisionDistributionSupervisionDivisionofMonitoringandRe-evaluation

Presentsit

DepartmentofMedicalDeviceRegistrationToconductregistrationforClassIIIandimportmedicaldevicesinstrictaccordancewiththeconditionsandproceduresprescribedbylaw,takethecorrespondentresponsibilities,optimizeregistrationcontrolprocedures,organizeandimplementclassificationadministration,andsupervisetheimplementationofgoodpracticesformedicaldevices.6DepartmentofMedi

DepartmentofMedicalDeviceSupervisionTotrackandanalyzemedicaldevicesafetysituationandexistingproblems,andtoputforwardrecommendationsonsystem,mechanismandperformanceimprovement;tosupervisethelow-leveladministrativedepartmentsinconductingadministrativelicensingbylaw,inperformingtheadministrativeduty,indetectingandrectifyingillegalandimproperactsintime;toorganizeandconductmedicaldeviceadverseeventsmonitoringandreevaluation.7DepartmentofMedicDepartmentofScience,TechnologyandStandardsToorganizeandimplementmajorscienceandtechnologyprogramsforfoodanddrugsupervision,acceleratetheconstructionoffoodanddrugtestingsystem,electronicsupervisiontrackingsystem,andinformationsystem;todraftqualificationrequirementsandtestingnormsgoverningfoodanddrugtestinginstitutions,andsupervisetheirimplementation;toorganizethedraftingofstandardsfordrugs,medicaldevices,cosmetics,andcatalogues,pharmaceuticaluserequirements,standardsforimmediatepackagingmaterialsandcontainers,andparticipateinthedraftingoffoodsafetystandards.8DepartmentofScience,Technol

TechnicalSupportinstitutesCenterofMedicalDeviceEvaluationCenterofMedicalDeviceStandardsManagementMedicalDeviceStandardsTechnicalCommitteesInstituteofMedicalDevice TestingCenterofDrugAdverseEventsMonitoringandReevaluation.9TechnicalSuppor

CharacteristicsofstructurereformStrengthenpostmarketsupervisionStressonR&Dandstandards10Characteristicsofst

Medicaldeviceregulationsystem11RegulationNormativeDocument

GuidancesRegulationsfortheSupervisionandAdministrationofMedicalDevicesORDER

NO.10\15\16Orderprovision\listsMedicaldeRegulationsfortheSupervisionandAdministrationofMedicalDevices條例：

RegulationsfortheSupervisionandAdministrationofMedicalDevicesStatecouncildirectiveNO.2762000.01.04Release

2000.04.01implement

12RegulationsfortheSupervisio

Regulationofmedicaldevice13Regulationofme14Technicalguidances國(guó)家食品藥品監(jiān)督管理局發(fā)布的醫(yī)療器械技術(shù)審評(píng)指導(dǎo)原則

第二類纖維內(nèi)窺鏡產(chǎn)品注冊(cè)技術(shù)審查指導(dǎo)原則

第二類硬管內(nèi)窺鏡產(chǎn)品注冊(cè)技術(shù)審查指導(dǎo)原則

中頻電療產(chǎn)品注冊(cè)技術(shù)審查指導(dǎo)原則

B型超聲診斷設(shè)備（第二類）產(chǎn)品注冊(cè)技術(shù)審查指導(dǎo)原則

心電圖機(jī)產(chǎn)品注冊(cè)技術(shù)審查指導(dǎo)原則

電動(dòng)手術(shù)臺(tái)指導(dǎo)原則

磁療產(chǎn)品注冊(cè)技術(shù)審查指導(dǎo)原則

電動(dòng)病床產(chǎn)品注冊(cè)技術(shù)審查指導(dǎo)原則

3A類半導(dǎo)體激光治療機(jī)產(chǎn)品注冊(cè)技術(shù)審查指導(dǎo)原則

電子血壓計(jì)（示波法）產(chǎn)品注冊(cè)技術(shù)審查指導(dǎo)原則

紅外乳腺檢查儀產(chǎn)品注冊(cè)技術(shù)審查指導(dǎo)原則

注射泵產(chǎn)品注冊(cè)技術(shù)審查指導(dǎo)原則

超聲理療設(shè)備產(chǎn)品注冊(cè)技術(shù)審查指導(dǎo)原則

牙科綜合治療機(jī)產(chǎn)品注冊(cè)技術(shù)審查指導(dǎo)原則

14Technicalguidances國(guó)家食品藥品監(jiān)督管

MedicalDeviceClassificationTheStateshallclassifymedicaldevicesandadministerthembasedonthisclassificationClassIMedicalDevicesarethoseforwhichsafetyandeffectivenesscanbeensuredthroughroutineadministration;ClassIIMedicalDevicesarethoseforwhichfurthercontrolisrequiredtoensuretheirsafetyandeffectivenessClassIIIMedicalDevicesarethosewhichareimplantedintothehumanbody,orusedforlifesupportorsustenance,orposepotential15MedicalDeviceClassi醫(yī)療器械法規(guī)和管理課件醫(yī)療器械法規(guī)和管理課件醫(yī)療器械法規(guī)和管理課件OrderNO.15

ProvisionsforMedicalDeviceClassificationArticle3TheProvisions

aremeanttodirecttheformulationofTheCategoryofMedicalDeviceClassificationaswellastodeterminetheclassesofnewlyregisteredproducts.

Article4Theclassificationofmedicaldevicesshouldbedeterminedbyacombinedjudgementonthreerespects:itsstructuralcharacteristics,formofoperationaswellasconditionsforuse.

Specifically,theirclassificationcanbebasedonCriteriaforMedicalDeviceClassification(seeappendix).

19OrderNO.15ProvisionsforMed20TheCategoryofMedicalDeviceClassification[2002]NO.3022002-09-05releaseAnnexTheCategoryofMedicalDeviceClassification20TheCategoryofMedicalDevi21RegistrationofMD－registrationofMDreferstoMDmustapprovalbydrugregulatoryauthoritybeforeaccesstomarket.－CMDEresponseforevaluationofapplicationdocuments

（CenterofMDEvaluation-CMDE）－DMDRresponseforapprovalofapplication（DepartmentofMDregistration）－Registrationcertificationvalidperiodis4years.

21RegistrationofMD－registrat22ClassificationregistrationArticle8TheStateshallimplementaproductregistrationsystemforthemanufacturingofmedicaldevices.ClassImedicaldevicesshallbeinspected,approvedandgrantedwitharegistrationcertificateby

thedrugregulatoryauthorityofthegovernmentofthemunicipalitiesconsistingofdistricts.ClassIImedicaldevicesshallbeinspected,approvedandgrantedwithregistrationcertificatesbythedrugregulatoryauthoritiesofprovinces,autonomousregionsandmunicipalitiesdirectlyunderthecentralgovernment.ClassIIImedicaldevicesshallbeinspected,approvedandgrantedwithregistrationcertificatesbythedrugregulatoryauthoritydirectlyundertheStateCouncil.ImportingMDshallbeinspected,approvedandgrantedwithregistrationcertificatesbythedrugregulatoryauthoritydirectlyundertheStateCouncil.22ClassificationregistrationAProvisionsforMedicalDeviceRegistration23－total

9

chapters,56Articles,12

Annexs.－actuallyregistrationorders,convenienceforApplicants.－addre-registration,Modify\Replacementcertification－12Annexshavesamelegaleffect.－greaterlegalaccountabilityefforts－conciselyphrase,Easytounderstand.ProvisionsforMedicalDeviceRegistrationprocess24R&DRPSFacilityEnterpriseLicense

TypetestingClinicaltrailQualitysystemauditCollectionmaterialsRegistrationRegistrationprocess24R&DRPSFa2525－Category

nationalstandard

(GB,GB/T)mandatory(GB,YY、YZB)、

industrialstandard(YY,YY/T)

recommend

(GB/T,YY/T)

registrationproductstandard(YZB)。－untilDEC.2012,Thereare1050

MDstandards，ofwhich

nationalstandards

180，ofwhichmandatorystandards90；

industrialsta