医疗器械法规和管理.ppt

,1,RegulationsofChinaMedicalDeviceSunjingshengBeijinginstituteofmedicaldevicetesting,2013.11,BIMT,withitsformernameBeijingMedicalDeviceTestingStation,wasestablishedin1983anditwasattachedtotheformerBeijingMedicalEquipmentInstitute.BIMThasreformedintoapublicinstitutionwithindependentjudicialpersonsince2000,whichwasanaffiliateofBJDA.SametimeItisasubordinateagencyofSFDA.,-BriefIntroductionofBIMT,Asanationalmedicaldevicetestingcenter,BIMTundertakestheassignmentssuchasregistrationtesting,supervisionsamplingtestingofmedicaldevicetesting,CCCcompulsorysafetycertificationtesting,testingofimporttosupervisethelow-leveladministrativedepartmentsinconductingadministrativelicensingbylaw,inperformingtheadministrativeduty,indetectingandrectifyingillegalandimproperactsintime;toorganizeandconductmedicaldeviceadverseeventsmonitoringandreevaluation.,8,DepartmentofScience,TechnologyandStandards,Toorganizeandimplementmajorscienceandtechnologyprogramsforfoodanddrugsupervision,acceleratetheconstructionoffoodanddrugtestingsystem,electronicsupervisiontrackingsystem,andinformationsystem;todraftqualificationrequirementsandtestingnormsgoverningfoodanddrugtestinginstitutions,andsupervisetheirimplementation;toorganizethedraftingofstandardsfordrugs,medicaldevices,cosmetics,andcatalogues,pharmaceuticaluserequirements,standardsforimmediatepackagingmaterialsandcontainers,andparticipateinthedraftingoffoodsafetystandards.,9,TechnicalSupportinstitutes,CenterofMedicalDeviceEvaluationCenterofMedicalDeviceStandardsManagementMedicalDeviceStandardsTechnicalCommitteesInstituteofMedicalDeviceTestingCenterofDrugAdverseEventsMonitoringandReevaluation.,10,Characteristicsofstructurereform,StrengthenpostmarketsupervisionStressonRClassIIMedicalDevicesarethoseforwhichfurthercontrolisrequiredtoensuretheirsafetyandeffectivenessClassIIIMedicalDevicesarethosewhichareimplantedintothehumanbody,orusedforlifesupportorsustenance,orposepotential,16,OrderNO.15ProvisionsforMedicalDeviceClassification,Article3TheProvisionsaremeanttodirecttheformulationofTheCategoryofMedicalDeviceClassificationaswellastodeterminetheclassesofnewlyregisteredproducts.Article4Theclassificationofmedicaldevicesshouldbedeterminedbyacombinedjudgementonthreerespects:itsstructuralcharacteristics,formofoperationaswellasconditionsforuse.Specifically,theirclassificationcanbebasedonCriteriaforMedicalDeviceClassification(seeappendix).,20,21,TheCategoryofMedicalDeviceC2002NO.3022002-09-05releaseAnnexTheCategoryofMedicalDeviceClassification,22,RegistrationofMD,registrationofMDreferstoMDmustapprovalbydrugregulatoryauthoritybeforeaccesstomarket.CMDEresponseforevaluationofapplicationdocuments（CenterofMDEvaluation-CMDE）DMDRresponseforapprovalofapplication（DepartmentofMDregistration）Registrationcertificationvalidperiodis4years.,23,Classificationregistration,Article8TheStateshallimplementaproductregistrationsystemforthemanufacturingofmedicaldevices.ClassImedicaldevicesshallbeinspected,approvedandgrantedwitharegistrationcertificatebythedrugregulatoryauthorityofthegovernmentofthemunicipalitiesconsistingofdistricts.ClassIImedicaldevicesshallbeinspected,approvedandgrantedwithregistrationcertificatesbythedrugregulatoryauthoritiesofprovinces,autonomousregionsandmunicipalitiesdirectlyunderthecentralgovernment.ClassIIImedicaldevicesshallbeinspected,approvedandgrantedwithregistrationcertificatesbythedrugregulatoryauthoritydirectlyundertheStateCouncil.ImportingMDshallbeinspected,approvedandgrantedwithregistrationcertificatesbythedrugregulatoryauthoritydirectlyundertheStateCouncil.,ProvisionsforMedicalDeviceRegistration,24,total9chapters,56Articles,12Annexs.actuallyregistrationorders,convenienceforApplicants.addre-registration,ModifyReplacementcertification12Annexshavesamelegaleffect.greaterlegalaccountabilityeffortsconciselyphrase,Easytounderstand.,Registrationprocess,25,26,26,Categorynationalstandard(GB,GB/T)mandatory(GB,YY、YZB)、industrialstandard(YY,YY/T)recommend(GB/T,YY/T)registrationproductstandard(YZB)。untilDEC.2012,Thereare1050MDstandards，ofwhichnationalstandards180，ofwhichmandatorystandards90；industrialstandards870，ofwhichmandatorystandards320.,StandardsofchinaMD,Standardizedtechnicalcommittee,Thereare22standardizedtechnicalcommitteesbeingresponsefordraftingandrevisingnationalandindustrialstandards,28,28,RPS,MDShouldhaveRPSincludingnationalstandardsandindustrialstandards，butrequirementsofRPSshallnotbelowerthanrequirementsofnationalandindustrialstandards.manufacturersareresponsibleforRPS.Chineseauthorityaddress“RPSisindustrialstandard,ifn