中國創(chuàng)新醫(yī)療器械特別審批程序介紹培訓(xùn)課件

隨著科學(xué)技術(shù)的進(jìn)步，醫(yī)療器械在臨床疾病的預(yù)防、診斷、治療中的作用越來越顯得重要。為了鼓勵醫(yī)療器械的研究與創(chuàng)新，讓更多創(chuàng)新的高科技醫(yī)療器械快速受惠于普通百姓，中國食品藥品監(jiān)督管理局頒布了《創(chuàng)新醫(yī)療器械特別審批程序（試行）》。Withtheprogressofscienceandtechnology,medicaldevicesintheroleofclinicaldiseaseprevention,diagnosis,andtreatmentismoreandmoreimportant.Toencourageresearchandinnovationinmedicaldevices,sothatmoreinnovativehigh-techmedicaldevicestorapidlybenefitordinarypeople,theState

Food

and

Drug

Administration(SFDA)issuedSpecialApprovalProcedureonInnovativeMedicalDevices(trial).

1中國創(chuàng)新醫(yī)療器械特別審批程序介紹1/25/2025一、哪些醫(yī)療器械產(chǎn)品屬于創(chuàng)新醫(yī)療器械，可以申報(bào)特別審批。I.Whichproductsareinnovativemedicaldevicesthatcandeclarespecialapproval2中國創(chuàng)新醫(yī)療器械特別審批程序介紹1/25/2025同時符合下列四點(diǎn)的產(chǎn)品屬于創(chuàng)新醫(yī)療器械范圍。Theproductsmeetingthefollowingfourpointsareinnovativerangeofmedicaldevices.3中國創(chuàng)新醫(yī)療器械特別審批程序介紹1/25/20251.申請者在中國依法擁有申報(bào)產(chǎn)品核心技術(shù)的發(fā)明專利權(quán)，或者依法通過受讓取得在中國發(fā)明專利權(quán)或其使用權(quán)；或者核心技術(shù)發(fā)明專利的申請已由國務(wù)院專利行政部門公開。

1）TheapplicantaccordingtothelawhavetherightofinventionpatentondeclaringcoretechnologyinChina,oraccordingtothelaw

throughthetransferee

obtainthepatentrightfor

invention

or

therighttouseinChina;ortheapplicationofinventionpatentoncoretechnologyhasbeenpublishedbythepatentadministrationdepartmentundertheStateCouncil.4中國創(chuàng)新醫(yī)療器械特別審批程序介紹1/25/20252.產(chǎn)品主要工作原理/作用機(jī)理為國內(nèi)首創(chuàng)，產(chǎn)品性能或者安全性與同類產(chǎn)品比較有根本性改進(jìn)，技術(shù)上處于國際領(lǐng)先水平。2.Themain

workingprinciple

/

mechanismofproductsarethefirstinthecountry.Productperformanceorsafetycomparedwithsimilarproducthasafundamentalimprovement,withtechnicallyaleadinginternationallevel.5中國創(chuàng)新醫(yī)療器械特別審批程序介紹1/25/20253.該產(chǎn)品具有顯著的臨床應(yīng)用價值。3.Theproducthassignificant

valueinclinicalapplication.6中國創(chuàng)新醫(yī)療器械特別審批程序介紹1/25/20254.已完成該產(chǎn)品的前期研究并具有基本定型產(chǎn)品，研究過程真實(shí)和受控，研究數(shù)據(jù)完整和可溯源。4.Havefinishedthepreliminaryresearchoftheproductandfinalizedthedesignedproduct.Theprocessofstudyisrealandcontrolled,withdata

integrity

andtraceability.7中國創(chuàng)新醫(yī)療器械特別審批程序介紹1/25/2025二、創(chuàng)新醫(yī)療器械特別審批獲得通過，有哪些優(yōu)惠政策II.Whatarethe

preferentialpoliciesforpassingthespecialapprovalofinnovativemedicaldevices8中國創(chuàng)新醫(yī)療器械特別審批程序介紹1/25/2025申請人所在地食品藥品監(jiān)督管理部門應(yīng)當(dāng)指定專人，應(yīng)申請人的要求及時溝通、提供指導(dǎo)。在接到申請人質(zhì)量管理體系檢查（考核）申請后，應(yīng)當(dāng)予以優(yōu)先辦理。Thelocalfoodanddrugsupervisionandadministrationauthorityshallappointsomeone,attherequestoftheapplicant,

provideguidancefor

timelycommunication.Uponreceiptoftheapplicanttocheckthequalitymanagementsystem(assessment)application,shouldbegivenpriority.9中國創(chuàng)新醫(yī)療器械特別審批程序介紹1/25/2025醫(yī)療器械檢測機(jī)構(gòu)在進(jìn)行注冊檢測時，應(yīng)當(dāng)及時對生產(chǎn)企業(yè)提交的產(chǎn)品標(biāo)準(zhǔn)或技術(shù)要求進(jìn)行預(yù)評價，對存在問題的，應(yīng)當(dāng)及時向生產(chǎn)企業(yè)提出修改建議。Whentestinginstitutionformedicaldevicesconductingregistrationtest,shouldpre-evaluatetimelyproductstandardsortechnicalrequirementssubmittedfromcompanies;ontheexistingproblems

ofthe

companies,

shallbetimelyproposedamendments.10中國創(chuàng)新醫(yī)療器械特別審批程序介紹1/25/2025醫(yī)療器械檢測機(jī)構(gòu)應(yīng)當(dāng)在接受樣品后優(yōu)先進(jìn)行醫(yī)療器械注冊檢測，并出具檢測報(bào)告。Testing

institutionformedicaldevicesshall

makearegistration

testfor

medicaldevicesinpriorityafteraccepting

samples

,

andissuethereport.11中國創(chuàng)新醫(yī)療器械特別審批程序介紹1/25/2025創(chuàng)新醫(yī)療器械的臨床試驗(yàn)應(yīng)當(dāng)按照醫(yī)療器械臨床試驗(yàn)相關(guān)規(guī)定的要求進(jìn)行，食品藥品監(jiān)督管理部門應(yīng)當(dāng)根據(jù)臨床試驗(yàn)的進(jìn)程進(jìn)行監(jiān)督檢查。Clinicaltrialsofinnovativemedicaldevicesshallbeinaccordancewiththerequirementsof

relatedregulationsonclinicaltrialsofmedicaldevices.Thefoodanddrugsupervisionandadministrationdepartmentshallmakesupervisionandinspectionaccordingtotheprocessofclinicaltrials.12中國創(chuàng)新醫(yī)療器械特別審批程序介紹1/25/2025在產(chǎn)品注冊申請受理前以及技術(shù)審評過程中，食品藥品監(jiān)管總局醫(yī)療器械技術(shù)審評中心應(yīng)當(dāng)指定專人，應(yīng)申請人的要求及時溝通、提供指導(dǎo)，共同討論相關(guān)技術(shù)問題。Beforeacceptinganapplicationforregistrationoftheproductandintheprocessoftechnicalreview,CenterforMedical

DeviceEvaluation

ofSFDAshalldesignatesomeone,attherequestoftheapplicant,

provideguidancefor

timelycommunicationanddiscusstherelatedtechnicalproblems.13中國創(chuàng)新醫(yī)療器械特別審批程序介紹1/25/2025企業(yè)可以通過申請與審評中心指定專人就以下問題進(jìn)行溝通交流：1.重大技術(shù)問題；2.重大安全性問題；3.臨床試驗(yàn)方案：4.階段性臨床試驗(yàn)結(jié)果的總結(jié)與評價；5.其他需要溝通交流的重要問題。EnterprisescanapplyforcommunicatingwithdesignatedpersonofEvaluation

Centeronthefollowingissues:1.Majortechnicalproblems;2.Majorsafetyissues;3.Clinicaltrialschemes;4.Periodicsummaryandevaluationoftheresultsofclinicaltrials;5.Theotherimportantissuesthat

needtocommunicate.14中國創(chuàng)新醫(yī)療器械特別審批程序介紹1/25/2025受理創(chuàng)新醫(yī)療器械注冊申請后，應(yīng)當(dāng)將該注冊申請項(xiàng)目標(biāo)記為“創(chuàng)新醫(yī)療器械”，并及時進(jìn)行注冊申報(bào)資料流轉(zhuǎn)。Afteracceptingtheapplicationforregistrationofinnovativemedicaldevices,theregistrationitemsshallbemarkedas"innovativemedicaldevices",andregistertodeclareinformationflowinatimelymanner.15中國創(chuàng)新醫(yī)療器械特別審批程序介紹1/25/2025已受理注冊申報(bào)的創(chuàng)新醫(yī)療器械，食品藥品監(jiān)管總局醫(yī)療器械技術(shù)審評中心應(yīng)當(dāng)優(yōu)先進(jìn)行技術(shù)審評；技術(shù)審評結(jié)束后，食品藥品監(jiān)管總局優(yōu)先進(jìn)行行政審批。Fortheinnovativemedicaldevicesthathavebeendeclaredtoaccepttheregistration,CenterforMedicalDevicesEvaluation,SFDAshouldgiveprioritytothetechnicalreview;afterthetechnicalevaluation,SFDAisprioritytoadministrativeapproval.16中國創(chuàng)新醫(yī)療器械特別審批程序介紹1/25/2025三、申報(bào)創(chuàng)新醫(yī)療器械特別審批應(yīng)準(zhǔn)備哪些資料III.Whatinformationshouldbereadyfordeclaringthespecialapprovalofinnovativemedicaldevices17中國創(chuàng)新醫(yī)療器械特別審批程序介紹1/25/20251.申請人企業(yè)法人資格證明文件；2.產(chǎn)品知識產(chǎn)權(quán)情況及證明文件；3.產(chǎn)品研發(fā)過程及結(jié)果的綜述；1.Legal

person

qualification

certificates

of

theapplicant;2.Intellectualpropertyinformationandsupportingdocumentsofproducts;3.Summaryofproductdevelopmentprocessandresults;18中國創(chuàng)新醫(yī)療器械特別審批程序介紹1/25/2025

4.產(chǎn)品技術(shù)文件，至少應(yīng)當(dāng)包括：①產(chǎn)品的預(yù)期用途；②產(chǎn)品工作原理/作用機(jī)理；

4.Technicaldocumentsofproductsshouldincludeatleast1)Theintendeduseofproducts;2)Theworkingprincipleandmechanism

of

products;19中國創(chuàng)新醫(yī)療器械特別審批程序介紹1/25/2025③產(chǎn)品主要技術(shù)指標(biāo)及確定依據(jù)，主要原材料、關(guān)鍵元器件的指標(biāo)要求，主要生產(chǎn)工藝過程及流程圖，主要技術(shù)指標(biāo)的檢驗(yàn)方法。3)Themaintechnicalindicatorsandbasisofproducts,themainrawmaterials,theindexrequirementsofkeycomponents,themainproduction

process

andflowchart,andthetestingmethodofmaintechnicalindicators.20中國創(chuàng)新醫(yī)療器械特別審批程序介紹1/25/20255.產(chǎn)品創(chuàng)新的證明性文件，至少應(yīng)當(dāng)包括：①信息或者專利檢索機(jī)構(gòu)出具的查新報(bào)告；②核心刊物公開發(fā)表的能夠充分說明產(chǎn)品臨床應(yīng)用價值的學(xué)術(shù)論文、專著及文件綜述；5.Documentedevidenceofproductinnovationincludeatleast1)Thetestingreportissued

byinformationorpatentsearchagency;2)Academicpapers,

monographsand

documents

reviewpublishedincorejournalsthatcanfullyexplaintheclinicalapplicationvalue.21中國創(chuàng)新醫(yī)療器械特別審批程序介紹1/25/2025③國內(nèi)外已上市同類產(chǎn)品應(yīng)用情況的分析及對比（如有）；④產(chǎn)品的創(chuàng)新內(nèi)容及在臨床應(yīng)用的顯著價值。3)Analysisandcomparisonintheapplicationofsimilarproductsalreadylistedonthemarketathomeandabroad(ifany);4)

Theinnovationcontentof

productsand

significant

value

in

clinicalapplication.22中國創(chuàng)新醫(yī)療器械特別審批程序介紹1/25/20256.產(chǎn)品安全風(fēng)險(xiǎn)管理報(bào)告。7.產(chǎn)品說明書。8.其他證明產(chǎn)品符合創(chuàng)新醫(yī)療器械要求的資料。6.Areportonsafety

andriskmanagementofproducts.7.ProductManual.8.Othersupportinginformationthatcanprovetomeetthe

requirementsof

innovative

medicaldevices.23中國創(chuàng)新醫(yī)療器械特別審批程序介紹1/25/20259.境外申請人應(yīng)當(dāng)委托中國境內(nèi)的企業(yè)法人作為代理人或者由其在中國境內(nèi)的辦事機(jī)構(gòu)提出申請，并提交以下文件：9.AnoverseasapplicantshallentrustalegalpersonofenterpriseinChinaasanagentorbyitsofficesinChina,applyforandsubmitthefollowingdocuments:24中國創(chuàng)新醫(yī)療器械特別審批程序介紹1/25/2025①境外申請人委托代理人或者其在中國境內(nèi)辦事機(jī)構(gòu)辦理創(chuàng)新醫(yī)療器械特別審批申請的委托書；1)OverseasapplicantsentrustagentoritsofficesinChinatodealwiththepowerofattorneyintheapplicationsofspecialapprovalforinnovativemedicaldevices.25中國創(chuàng)新醫(yī)療器械特別審批程序介紹1/25/2025②代理人或者申請人在中國境內(nèi)辦事機(jī)構(gòu)的承諾書；③代理人營業(yè)執(zhí)照或者申請人在中國境內(nèi)辦事機(jī)構(gòu)的機(jī)構(gòu)登記證明。2)LetterofcommitmentofagentorapplicantfromitsofficesinChina;3)BusinesslicenseofagentorregistrationcertificateofapplicantsofficesinChina's.26中國創(chuàng)新醫(yī)療器械特別審批程序介紹1/25/202510.所提交資料真實(shí)性的自我保證聲明。11.申報(bào)資料應(yīng)當(dāng)使用中文。原文為外文的，應(yīng)當(dāng)有中文譯本。10.Self-declaration

by

the

enterprise

to

guarantee

the

truthfulnessof

the

documentationsubmitted.11.All

documents

required

tobe

submitted

by

an

applicantshall

be

in

Chinese;if

the

original

document

is

in

a

foreign

language,

a

Chinesetranslation

shall

be

provided.27中國創(chuàng)新醫(yī)療器械特別審批程序介紹1/25/2025境內(nèi)申請人應(yīng)當(dāng)向其所在地的省級食品藥品監(jiān)督管理部門提出創(chuàng)新醫(yī)療器械特別審批申請，當(dāng)局于20個工作日內(nèi)出具初審意見。報(bào)送國家食品藥品監(jiān)督管理局。Adomesticapplicantshallapplyforspecialapprovalofinnovativemedical

devicestothelocalprovincialfoodanddrugsupervisionandadministrationdepartment.Andtheauthoritieswillissueapreliminaryexaminationopinionwithin20workingdays,submittingtoSFDA.28中國創(chuàng)新醫(yī)療器械特別審批程序介紹1/25/2025境外申請人應(yīng)當(dāng)向食品藥品監(jiān)管總局提出創(chuàng)新醫(yī)療器械特別審查，對符合本程序第四條規(guī)定的形式要求的予以受理。Anoverseasapplicantshallapplyforspecialapprovalofinnovativemedical

devicestoSFDA,whichwillbeacceptedincompliancewiththeprovisionsofArticleIV.29中國創(chuàng)新醫(yī)療器械特別審批程序介紹1/25/2025食品藥品監(jiān)管總局醫(yī)療器械技術(shù)審評中心設(shè)立創(chuàng)新醫(yī)療器械審查辦公室，授權(quán)中國生物醫(yī)學(xué)工程學(xué)會負(fù)責(zé)對創(chuàng)新醫(yī)療器械特別審批申請進(jìn)行審查，并于受理后40個工作日內(nèi)出具審查意見。CenterforMedicalDeviceEvaluation,SFDAsetupreviewofficeforinnovativemedicaldevices,authorizedChineseSocietyofBiomedicalEngineeringisresponsibleforareviewofspecialapprovaloninnovativemedicaldevicesandwillissueapreliminaryexaminationopinionwithin40workingdays.30中國創(chuàng)新醫(yī)療器械特別審批程序介紹1/25/2025經(jīng)創(chuàng)新醫(yī)療器械審查辦公室審查，對擬進(jìn)行特別審批的申請項(xiàng)目，在食品藥品監(jiān)管總局醫(yī)療器械技術(shù)審評中心網(wǎng)站將申請人、產(chǎn)品名稱予以公示，公示時間應(yīng)當(dāng)不少于10個工作日。對于有異議的，應(yīng)當(dāng)對相關(guān)意見研究后作出最終審查決定。ReviewedbytheOfficeforInnovativeMedicalDevices,fortheproposedapplicationonspecialapproval,announcetotheapplicantandtheproductnameinthewebsiteofCenterforMedicalDevicesEvaluationofSFDA，publicitytime

shallnotbe

lessthan10workingdays.Foranyobjection,itshall,afteradvicetorelatedresearch,makeadecisiononthefinalreview.31中國創(chuàng)新醫(yī)療器械特別審批程序介紹1/25/2025創(chuàng)新醫(yī)療器械審查辦公室作出審查決定后，將審查結(jié)果書面通知申請人，對境內(nèi)企業(yè)的申請，同時抄送申請人所在地省級食品藥品監(jiān)督管理部門。AfterreviewingbytheOfficeofInnovativeMedicalDevi