中国创新医疗器械特别审批程序介绍 顾汉卿

中国创新医疗器械特别审批程序介绍IntroductiontoSpecialApprovalProcedureonChina’sInnovativeMedicalDevices中国生物医学工程学会顾汉卿ChineseSocietyofBiomedicalEngineeringGuHanqing•随着科学技术的进步，医疗器械在临床疾病的预防、诊断、治疗中的作用越来越显得重要。为了鼓励医疗器械的研究与创新，让更多创新的高科技医疗器械快速受惠于普通百姓，中国食品药品监督管理局颁布了《创新医疗器械特别审批程序（试行）》。•Withtheprogressofscienceandtechnology,medicaldevicesintheroleofclinicaldiseaseprevention,diagnosis,andtreatmentismoreandmoreimportant.Toencourageresearchandinnovationinmedicaldevices,sothatmoreinnovativehigh-techmedicaldevicestorapidlybenefitordinarypeople,theStateFoodandDrugAdministration(SFDA)issuedSpecialApprovalProcedureonInnovativeMedicalDevices(trial).一、哪些医疗器械产品属于创新医疗器械，可以申报特别审批。I.Whichproductsareinnovativemedicaldevicesthatcandeclarespecialapproval?•同时符合下列四点的产品属于创新医疗器械范围。•Theproductsmeetingthefollowingfourpointsareinnovativerangeofmedicaldevices.1.申请者在中国依法拥有申报产品核心技术的发明专利权，或者依法通过受让取得在中国发明专利权或其使用权；或者核心技术发明专利的申请已由国务院专利行政部门公开。1）TheapplicantaccordingtothelawhavetherightofinventionpatentondeclaringcoretechnologyinChina,oraccordingtothelawthroughthetransfereeobtainthepatentrightforinventionortherighttouseinChina;ortheapplicationofinventionpatentoncoretechnologyhasbeenpublishedbythepatentadministrationdepartmentundertheStateCouncil.2.产品主要工作原理/作用机理为国内首创，产品性能或者安全性与同类产品比较有根本性改进，技术上处于国际领先水平。2.Themainworkingprinciple/mechanismofproductsarethefirstinthecountry.Productperformanceorsafetycomparedwithsimilarproducthasafundamentalimprovement,withtechnicallyaleadinginternationallevel.3.该产品具有显著的临床应用价值。3.Theproducthassignificantvalueinclinicalapplication.4.已完成该产品的前期研究并具有基本定型产品，研究过程真实和受控，研究数据完整和可溯源。4.Havefinishedthepreliminaryresearchoftheproductandfinalizedthedesignedproduct.Theprocessofstudyisrealandcontrolled,withdataintegrityandtraceability.二、创新医疗器械特别审批获得通过，有哪些优惠政策?II.Whatarethepreferentialpoliciesforpassingthespecialapprovalofinnovativemedicaldevices?•申请人所在地食品药品监督管理部门应当指定专人，应申请人的要求及时沟通、提供指导。在接到申请人质量管理体系检查（考核）申请后，应当予以优先办理。•Thelocalfoodanddrugsupervisionandadministrationauthorityshallappointsomeone,attherequestoftheapplicant,provideguidancefortimelycommunication.Uponreceiptoftheapplicanttocheckthequalitymanagementsystem(assessment)application,shouldbegivenpriority.•医疗器械检测机构在进行注册检测时，应当及时对生产企业提交的产品标准或技术要求进行预评价，对存在问题的，应当及时向生产企业提出修改建议。•Whentestinginstitutionformedicaldevicesconductingregistrationtest,shouldpre-evaluatetimelyproductstandardsortechnicalrequirementssubmittedfromcompanies;ontheexistingproblemsofthecompanies,shallbetimelyproposedamendments.•医疗器械检测机构应当在接受样品后优先进行医疗器械注册检测，并出具检测报告。•Testinginstitutionformedicaldevicesshallmakearegistrationtestformedicaldevicesinpriorityafteracceptingsamples,andissuethereport.•创新医疗器械的临床试验应当按照医疗器械临床试验相关规定的要求进行，食品药品监督管理部门应当根据临床试验的进程进行监督检查。•Clinicaltrialsofinnovativemedicaldevicesshallbeinaccordancewiththerequirementsofrelatedregulationsonclinicaltrialsofmedicaldevices.Thefoodanddrugsupervisionandadministrationdepartmentshallmakesupervisionandinspectionaccordingtotheprocessofclinicaltrials.•在产品注册申请受理前以及技术审评过程中，食品药品监管总局医疗器械技术审评中心应当指定专人，应申请人的要求及时沟通、提供指导，共同讨论相关技术问题。•Beforeacceptinganapplicationforregistrationoftheproductandintheprocessoftechnicalreview,CenterforMedicalDeviceEvaluationofSFDAshalldesignatesomeone,attherequestoftheapplicant,provideguidancefortimelycommunicationanddiscusstherelatedtechnicalproblems.•企业可以通过申请与审评中心指定专人就以下问题进行沟通交流：1.重大技术问题；2.重大安全性问题；3.临床试验方案：4.阶段性临床试验结果的总结与评价；5.其他需要沟通交流的重要问题。•EnterprisescanapplyforcommunicatingwithdesignatedpersonofEvaluationCenteronthefollowingissues:1.Majortechnicalproblems;2.Majorsafetyissues;3.Clinicaltrialschemes;4.Periodicsummaryandevaluationoftheresultsofclinicaltrials;5.Theotherimportantissuesthatneedtocommunicate.•受理创新医疗器械注册申请后，应当将该注册申请项目标记为“创新医疗器械”，并及时进行注册申报资料流转。•Afteracceptingtheapplicationforregistrationofinnovativemedicaldevices,theregistrationitemsshallbemarkedasinnovativemedicaldevices,andregistertodeclareinformationflowinatimelymanner.•已受理注册申报的创新医疗器械，食品药品监管总局医疗器械技术审评中心应当优先进行技术审评；技术审评结束后，食品药品监管总局优先进行行政审批。•Fortheinnovativemedicaldevicesthathavebeendeclaredtoaccepttheregistration,CenterforMedicalDevicesEvaluation,SFDAshouldgiveprioritytothetechnicalreview;afterthetechnicalevaluation,SFDAisprioritytoadministrativeapproval.三、申报创新医疗器械特别审批应准备哪些资料?III.Whatinformationshouldbereadyfordeclaringthespecialapprovalofinnovativemedicaldevices?1.申请人企业法人资格证明文件；2.产品知识产权情况及证明文件；3.产品研发过程及结果的综述；1.Legalpersonqualificationcertificatesoftheapplicant;2.Intellectualpropertyinformationandsupportingdocumentsofproducts;3.Summaryofproductdevelopmentprocessandresults;4.产品技术文件，至少应当包括：①产品的预期用途；②产品工作原理/作用机理；4.Technicaldocumentsofproductsshouldincludeatleast1)Theintendeduseofproducts;2)Theworkingprincipleandmechanismofproducts;③产品主要技术指标及确定依据，主要原材料、关键元器件的指标要求，主要生产工艺过程及流程图，主要技术指标的检验方法。3)Themaintechnicalindicatorsandbasisofproducts,themainrawmaterials,theindexrequirementsofkeycomponents,themainproductionprocessandflowchart,andthetestingmethodofmaintechnicalindicators.5.产品创新的证明性文件，至少应当包括：–①信息或者专利检索机构出具的查新报告；–②核心刊物公开发表的能够充分说明产品临床应用价值的学术论文、专著及文件综述；5.Documentedevidenceofproductinnovationincludeatleast1)Thetestingreport