2009/3/31Department1FDAFDA法规培训法规培训--QSRandFactoryQSRandFactoryInspectionInspection孙永健TUVSUDGROUP31March2009Medical-Health-ServiceDepartment自我介绍孙永健NotifiedBodyLeadAuditorandProductSpecialistNotifiedBodyLeadAuditorandProductSpecialistFDAThirdPartyReviewerProjectManagerTUVProductServiceLtd.(memberofTUVSudGroup)TÜVAsiaPacificHoldingLtd.31March2009Department2009/3/31Department2培训目的本次培训的目的:•了解FDA对医疗设备企业的质量体系要求•了解FDA的工厂检测机制TÜVAsiaPacificHoldingLtd.31March2009Department培训大纲•FDA是什么样的机构FDA是什么样的机构•什么是QSR820•什么是FDA工厂检查•FDA在查什么•如何准备FDA工厂检查FDA工厂检查实例TÜVAsiaPacificHoldingLtd.31March2009Department•FDA工厂检查实例2009/3/31Department3FDA是什么机构FDA是美国食品药品管理局的英文缩写(TheFood是美国食品药品管理局的英文缩写(andDragAdministration),主要作用是对进入美国市场的食品,药品,医疗器械和化妆品等的生产与销售企业进行管理与监督。TÜVAsiaPacificHoldingLtd.31March2009DepartmentFDA是什么机构从对人体安全影响的角度,FDA将医疗器械分成三类:•1类医疗器械:一般控制(establishmentregistration、devicelisting)•2类医疗器械:一般控制+特殊控制•3类医疗器械:一般控制+入市前批准(PMA)PMA=Pre-marketApprovalTÜVAsiaPacificHoldingLtd.31March2009Department2009/3/31Department4FDA是什么机构对较有代表性的2类医疗器械,主要有以下三方面的申请:请•企业登记(establishmentregistration)•产品注册(devicelisting)•以及510(K)认可(也叫市场准入许可)TÜVAsiaPacificHoldingLtd.31March2009DepartmentFDA是什么机构•FDA工厂检查:是FDA对医疗器械实际生产现场的调查。•检查对象:所有在美国境内销售医疗器械的制造商,包括美国国内和国外的制造商。•由美国FDA派出调查员到医疗器械实际生产场所,执行对工厂的调查,以确定被检TÜVAsiaPacificHoldingLtd.31March2009Department查的工厂是否符合QSR(820)法规的要求。•FDA的工厂检查是官方的检查,不收取费用,不发证书2009/3/31Department5FDA是什么机构•FDA从2008年11月开始,在中国设立了三个办事处:北京,上海和广州上海和广州。•总共八名专家在三个地方办公,涉及食品,药品和器械。TÜVAsiaPacificHoldingLtd.31March2009Department培训大纲•FDA是什么样的机构FDA是什么样的机构•什么是QSR820•什么是FDA工厂检查•FDA在查什么•如何准备FDA工厂检查FDA工厂检查实例TÜVAsiaPacificHoldingLtd.31March2009Department•FDA工厂检查实例2009/3/31Department6什么是QSR820美国联邦法规CodeofFederalRegulation,Title21.•Part820QualitySystemRegulation•Part803MedicalDeviceReporting•Part806MedicalDeviceCorrectionsandRemovals•Part821MedicalDeviceTrackingTÜVAsiaPacificHoldingLtd.31March2009DepartmentQSR820和ISO13485:2003的关系ISO13485是否可以替代QSR820?ISO13485:2003QSR(820)•QSR820多于ISO1348的要求TÜVAsiaPacificHoldingLtd.31March2009DepartmentQ()13485的要求。•QSR820比ISO13485更详细2009/3/31Department7A–总则B–质量体系要求C–设计控制QSRSubpartA–GeneralProvisions(820.10)A-GENERALPROVISIONSB-QUALITYSYSTEMREQUIREMENTSC-DESIGNCONTROLSC设计控制D–文件及记录控制E–采购控制F–标识及追踪G–生产及过程控制H–验收I–不合格部件及设备纠防性措施D-DOCUMENTANDRECORDCONTROLE-PURCHASINGCONTROLSF-IDENTIFICATIONANDTRACEABILITYG-PRODUCTIONANDPROCESSCONTROLSH-ACCEPTANCEACTIVITIESI-NONCONFORMINGCOMPONENTSANDDEVICESJ-CORRECTIVEANDPREVENTIVEACTIONTÜVAsiaPacificHoldingLtd.31March2009DepartmentJ–纠正及预防性措施K–标签及包装控制L–处理、储存、销售及安装M–记录N–维修O–统计技术JCORRECTIVEANDPREVENTIVEACTIONK-LABELINGANDPACKAGINGCONTROLL-HANDLING,STORAGE,DISTRIBUTION,ANDINSTALLATIONM-RECORDSN-SERVICINGO-STATISTICALTECHNIQUESQSRSubpartB–MANAGEMENTRESPONSIBILITY•Managementmustestablishaqualitypolicyandobjectives.管理者必须建立质量方针及目标。•Managementshallensurethatthequalitypolicyisunderstood,implemented,andmaintainedatalllevelsoftheorganization.管理者要确保质量方针在组织的所有层次中被理解,实施和维持。TÜVAsiaPacificHoldingLtd.31March2009Department•Eachmanufacturershallestablishandmaintainanadequateorganizationalstructuretoensurethatdevicesaredesignedandproducedinaccordancewiththerequirementsofthispart.制造商必须建立和维护有效的组织结构,以保证产品的设计和生产是符合质量体系要求的。2009/3/31Department8QSRSubpartB–MANAGEMENTRESPONSIBILITY•Mustappointamanagerresponsibleforcompliance.必须指定一名负责符合性的管理者。•Managementshallreviewthesuitabilityandeffectivenessofthequalitysystematdefinedintervals.管理者要在定义好的间隔评审质量管理体系的适宜性和有效性。•Eachmanufacturershallestablishaqualityplanwhichdefinesthequalitypractices,resources,andactivitiesrelevanttodevicesthataredesigneddftdTÜVAsiaPacificHoldingLtd.31March2009Departmentandmanufactured.制造商必须为它设计和生产的设备制订质量计划。•Proceduresandinstructionsmustbeestablished必须建立相关的程序和说明,而且要描述质量体系文件的结构。QSRSubpartB–QUALITYAUDIT•Mustconductauditstomakesurethesystemworks.必须进行审核以确保质量系统有效运行。•Auditorsneedtobeindependent.审核员需要是独立的。•Correctiveactionmustbetakenwhennecessary.审核后的纠正性措施必须适时实施。•Resultsmustbereviewedbythemanagement.TÜVAsiaPacificHoldingLtd.31March2009Department管理层必须对结果进行审评。•Datesoftheauditsmustbedocumented.内审日期必须被记录。2009/3/31Department9QSRSubpartB–PERSONNEL•Employeesmusthaveeducation,background,trainingandexperience职员必须接受教育和培训,并有相关背景和经验。•Companymustidentifytrainingneedsanddocumenttraining.公司必须建立培训程序,识别培训需求并保持培训记录。•Employeesmustbemadeawareofdefectsthatcouldresultfromimproperperformanceoftheirjob.职员必须明确那些由于他们操作失误而导致的不足。TÜVAsiaPacificHoldingLtd.31March2009Department•Personnelwhoperformverificationandvalidationactivitiesshallbemadeawareofdefectsanderrorsthatmaybeencounteredaspartoftheirjobfunctions.从事检验和确认工作的员工必须明确那些会导致产品缺陷的错误。QSRSubpartC–DESIGNCONTROLS•AppliestoallClass2and3devices;someClass1对于所有2、3类设备及部分1类设备的制造商必须建立设计控制程序造商必须建立设计控制程序•Manufacturermustestablishdesignplanswhichdefineresponsibilityforimplementationandinterfacewithdifferentgroups.制造商必须制定设计计划,并且定义过程中的责任人和小组间的接口。TÜVAsiaPacificHoldingLtd.31March2009Department•Theplansshallbereviewed,updated,andapprovedasdesignanddevelopmentevolves.设计计划必须随着项目的推进被评审,更新和批准。2009/3/31Department10QSRSubpartC–DESIGNCONTROLS•Mustmakesuredesigninput(designrequirements)rela