1、中國(guó)創(chuàng)新醫(yī)療器械特別審批程序介紹新版特別審中國(guó)創(chuàng)新醫(yī)療器械特別審批程序介紹新版特別審隨著科學(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(lái)越顯得重要。為了鼓勵(lì)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(guó)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）。With the progress of science and technology, medical devices in the role of clinical disease prevention, diagnosis, and treatment is more and more im

2、portant. To encourage research and innovation in medical devices, so that more innovative high-tech medical devices to rapidly benefit ordinary people, the StateFoodandDrugAdministration (SFDA) issued Special Approval Procedure on Innovative Medical Devices (trial). 中國(guó)創(chuàng)新醫(yī)療器械特別審批程序介紹新版特別審隨著科學(xué)技術(shù)的進(jìn)步，醫(yī)療

3、器械在臨床疾病的預(yù)防、診斷、治療中的 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. Which products are innovative medical devices that can declare special approval?中國(guó)創(chuàng)新醫(yī)療器械特別審批程序介紹新版特別審 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)特同時(shí)符合下列四點(diǎn)的產(chǎn)品屬于創(chuàng)新醫(yī)療器械范圍。The products meeting the following four points are innovative range of medical devices.中國(guó)創(chuàng)新醫(yī)療器械特別審批程序

4、介紹新版特別審?fù)瑫r(shí)符合下列四點(diǎn)的產(chǎn)品屬于創(chuàng)新醫(yī)療器械范圍。The prod 1.申請(qǐng)者在中國(guó)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(guò)受讓取得在中國(guó)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(qǐng)已由國(guó)務(wù)院專利行政部門公開(kāi)。 1）The applicant according to the law have the right of invention patent on declaring core technology in China, or according to the lawthrough the transfereeobtain the patent right for

5、inventionorthe right to use in China; or the application of invention patent on core technology has been published by the patent administration department under the State Council.中國(guó)創(chuàng)新醫(yī)療器械特別審批程序介紹新版特別審 1.申請(qǐng)者在中國(guó)依法擁有申報(bào)產(chǎn)品核心技術(shù)的發(fā)明專利權(quán)， 2.產(chǎn)品主要工作原理/作用機(jī)理為國(guó)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(guó)際領(lǐng)先水平。 2. The mainwor

6、king principle/mechanism of products are the first in the country. Product performance or safety compared with similar product has a fundamental improvement, with technically a leading international level.中國(guó)創(chuàng)新醫(yī)療器械特別審批程序介紹新版特別審 2.產(chǎn)品主要工作原理/作用機(jī)理為國(guó)內(nèi)首創(chuàng)，產(chǎn)品性能或者 3.該產(chǎn)品具有顯著的臨床應(yīng)用價(jià)值。 3. The product has signific

7、antvalue in clinical application.中國(guó)創(chuàng)新醫(yī)療器械特別審批程序介紹新版特別審 3.該產(chǎn)品具有顯著的臨床應(yīng)用價(jià)值。 3. The 4.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(guò)程真實(shí)和受控，研究數(shù)據(jù)完整和可溯源。 4. Have finished the preliminary research of the product and finalized the designed product. The process of study is real and controlled, with dataintegrityand traceability.中國(guó)

8、創(chuàng)新醫(yī)療器械特別審批程序介紹新版特別審 4.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(guò)程 二、創(chuàng)新醫(yī)療器械特別審批獲得通過(guò)，有哪些優(yōu)惠政策? II. What are thepreferential policies for passing the special approval of innovative medical devices?中國(guó)創(chuàng)新醫(yī)療器械特別審批程序介紹新版特別審 二、創(chuàng)新醫(yī)療器械特別審批獲得通過(guò)，有哪些優(yōu)惠政策? 申請(qǐng)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(qǐng)人的要求及時(shí)溝通、提供指導(dǎo)。在接到申請(qǐng)人質(zhì)量管理體系檢查（考核）申請(qǐng)后，應(yīng)當(dāng)予以優(yōu)先辦理。The lo

9、cal food and drug supervision and administration authority shall appoint someone, at the request of the applicant,provide guidance fortimely communication. Upon receipt of the applicant to check the quality management system (assessment) application, should be given priority.中國(guó)創(chuàng)新醫(yī)療器械特別審批程序介紹新版特別審申請(qǐng)人

10、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(qǐng)人的要求醫(yī)療器械檢測(cè)機(jī)構(gòu)在進(jìn)行注冊(cè)檢測(cè)時(shí)，應(yīng)當(dāng)及時(shí)對(duì)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(píng)價(jià)，對(duì)存在問(wèn)題的，應(yīng)當(dāng)及時(shí)向生產(chǎn)企業(yè)提出修改建議。When testing institution for medical devices conducting registration test, should pre-evaluate timely product standards or technical requirements submitted from companies; on the existing problemsof the com

11、panies,shall be timely proposed amendments.中國(guó)創(chuàng)新醫(yī)療器械特別審批程序介紹新版特別審醫(yī)療器械檢測(cè)機(jī)構(gòu)在進(jìn)行注冊(cè)檢測(cè)時(shí)，應(yīng)當(dāng)及時(shí)對(duì)生產(chǎn)企業(yè)提交的產(chǎn)醫(yī)療器械檢測(cè)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(cè)檢測(cè)，并出具檢測(cè)報(bào)告。Testinginstitution for medical devices shallmake a registrationtest formedical devices in priority after acceptingsamples,and issue the report. 中國(guó)創(chuàng)新醫(yī)療器械特別審批程序介紹新版特別審醫(yī)療器械

12、檢測(cè)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(cè)檢測(cè)，并創(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。Clinical trials of innovative medical devices shall be in accordance with the requirements ofrelated regulations on clinical trials of medical devices. The food and drug supervision and administration department s

13、hall make supervision and inspection according to the process of clinical trials.中國(guó)創(chuàng)新醫(yī)療器械特別審批程序介紹新版特別審創(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)定的要求在產(chǎn)品注冊(cè)申請(qǐng)受理前以及技術(shù)審評(píng)過(guò)程中，食品藥品監(jiān)管總局醫(yī)療器械技術(shù)審評(píng)中心應(yīng)當(dāng)指定專人，應(yīng)申請(qǐng)人的要求及時(shí)溝通、提供指導(dǎo)，共同討論相關(guān)技術(shù)問(wèn)題。Before accepting an application for registration of the product and in the process of technical

14、 review, Center for MedicalDevice Evaluationof SFDA shall designate someone, at the request of the applicant,provide guidance fortimely communication and discuss the related technical problems.中國(guó)創(chuàng)新醫(yī)療器械特別審批程序介紹新版特別審在產(chǎn)品注冊(cè)申請(qǐng)受理前以及技術(shù)審評(píng)過(guò)程中，食品藥品監(jiān)管總局醫(yī)療企業(yè)可以通過(guò)申請(qǐng)與審評(píng)中心指定專人就以下問(wèn)題進(jìn)行溝通交流： 1. 重大技術(shù)問(wèn)題； 2. 重大安全性問(wèn)題； 3.

15、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(píng)價(jià)； 5. 其他需要溝通交流的 重要問(wèn)題。Enterprises can apply for communicating with designated person of EvaluationCenter on the following issues: 1. Major technical problems; 2. Major safety issues; 3. Clinical trial schemes; 4. Periodic summary and evaluation of the results of clinical tri

16、als; 5. The other important issues thatneed to communicate.中國(guó)創(chuàng)新醫(yī)療器械特別審批程序介紹新版特別審企業(yè)可以通過(guò)申請(qǐng)與審評(píng)中心指定專人就以下問(wèn)題進(jìn)行溝通交流：E受理創(chuàng)新醫(yī)療器械注冊(cè)申請(qǐng)后，應(yīng)當(dāng)將該注冊(cè)申請(qǐng)項(xiàng)目標(biāo)記為“創(chuàng)新醫(yī)療器械”，并及時(shí)進(jìn)行注冊(cè)申報(bào)資料流轉(zhuǎn)。After accepting the application for registration of innovative medical devices, the registration items shall be marked as innovative medical

17、 devices, and register to declare information flow in a timely manner.中國(guó)創(chuàng)新醫(yī)療器械特別審批程序介紹新版特別審受理創(chuàng)新醫(yī)療器械注冊(cè)申請(qǐng)后，應(yīng)當(dāng)將該注冊(cè)申請(qǐng)項(xiàng)目標(biāo)記為“創(chuàng)新已受理注冊(cè)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(píng)中心應(yīng)當(dāng)優(yōu)先進(jìn)行技術(shù)審評(píng)；技術(shù)審評(píng)結(jié)束后，食品藥品監(jiān)管總局優(yōu)先進(jìn)行行政審批。For the innovative medical devices that have been declared to accept the registration, Center for Medical Devi

18、ces Evaluation, SFDA should give priority to the technical review; after the technical evaluation, SFDA is priority to administrative approval.中國(guó)創(chuàng)新醫(yī)療器械特別審批程序介紹新版特別審已受理注冊(cè)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 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. What information should be ready for declaring the special approval of innova

19、tive medical devices? 中國(guó)創(chuàng)新醫(yī)療器械特別審批程序介紹新版特別審 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. 1.申請(qǐng)人企業(yè)法人資格證明文件； 2.產(chǎn)品知識(shí)產(chǎn)權(quán)情況及證明文件； 3.產(chǎn)品研發(fā)過(guò)程及結(jié)果的綜述； 1.Legalpersonqualificationcertificatesofthe applicant; 2.Intellectual property information and supporting documents of products; 3.Summary of product development process and resu

20、lts;中國(guó)創(chuàng)新醫(yī)療器械特別審批程序介紹新版特別審 1.申請(qǐng)人企業(yè)法人資格證明文件； 1.Legalper 4.產(chǎn)品技術(shù)文 件，至少應(yīng)當(dāng) 包括： 產(chǎn)品的預(yù)期用 途； 產(chǎn)品工作原理/ 作用機(jī)理； 4.Technical documents of products should include at least 1) The intended use of products; 2) The working principle and mechanismofproducts; 中國(guó)創(chuàng)新醫(yī)療器械特別審批程序介紹新版特別審 4.產(chǎn)品技術(shù)文 4.Technical 產(chǎn)品主要技術(shù)指標(biāo)及確定依據(jù)，主要原材料、

21、關(guān)鍵元器件的指標(biāo)要求，主要生產(chǎn)工藝過(guò)程及流程圖，主要技術(shù)指標(biāo)的檢驗(yàn)方法。 3) The main technical indicators and basis of products, the main raw materials, the index requirements of key components, the main productionprocessand flow chart, and the testing method of main technical indicators.中國(guó)創(chuàng)新醫(yī)療器械特別審批程序介紹新版特別審 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

22、的指 5.產(chǎn)品創(chuàng)新的證明性文件，至少應(yīng)當(dāng)包括：信息或者專利檢索機(jī)構(gòu)出具的查新報(bào)告；核心刊物公開(kāi)發(fā)表的能夠充分說(shuō)明產(chǎn)品臨床應(yīng)用價(jià)值的學(xué)術(shù)論文、專著及文件綜述； 5. Documented evidence of product innovation include at least 1) The testing report issuedby information or patent search agency; 2) Academic papers, monographs anddocumentsreview published in core journals that can fully

23、 explain the clinical application value.中國(guó)創(chuàng)新醫(yī)療器械特別審批程序介紹新版特別審 5.產(chǎn)品創(chuàng)新的證明性文件，至少應(yīng)當(dāng)包括： 5國(guó)內(nèi)外已上市同類產(chǎn)品應(yīng)用情況的分析及對(duì)比（如有）；產(chǎn)品的創(chuàng)新內(nèi)容及在臨床應(yīng)用的顯著價(jià)值。 3) Analysis and comparison in the application of similar products already listed on the market at home and abroad (if any); 4)The innovation content ofproducts andsignific

24、antvalueinclinical application.中國(guó)創(chuàng)新醫(yī)療器械特別審批程序介紹新版特別審國(guó)內(nèi)外已上市同類產(chǎn)品應(yīng)用情況的分析及對(duì)比（如有）； 3 6.產(chǎn)品安全風(fēng)險(xiǎn)管理報(bào)告。 7.產(chǎn)品說(shuō)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. A report on safetyand risk management of products. 7. Product Manual. 8. Other supporting information that can prove to meet therequirements ofinnovativemedical devices.中國(guó)

25、創(chuàng)新醫(yī)療器械特別審批程序介紹新版特別審 6.產(chǎn)品安全風(fēng)險(xiǎn)管理報(bào)告。 6. A repor 9.境外申請(qǐng)人應(yīng)當(dāng)委托中國(guó)境內(nèi)的企業(yè)法人作為代理人或者由其在中國(guó)境內(nèi)的辦事機(jī)構(gòu)提出申請(qǐng)，并提交以下文件： 9.An overseas applicant shall entrust a legal person of enterprise in China as an agent or by its offices in China, apply for and submit the following documents:中國(guó)創(chuàng)新醫(yī)療器械特別審批程序介紹新版特別審 9.境外申請(qǐng)人應(yīng)當(dāng)委托中國(guó)境內(nèi)的企業(yè)法

26、人作為代理人或者由 境外申請(qǐng)人委托代理人或者其在中國(guó)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(qǐng)的委托書； 1) Overseas applicants entrust agent or its offices in China to deal with the power of attorney in the applications of special approval for innovative medical devices.中國(guó)創(chuàng)新醫(yī)療器械特別審批程序介紹新版特別審 境外申請(qǐng)人委托代理人或者其在中國(guó)境內(nèi)辦事機(jī)構(gòu)辦理創(chuàng)新 代理人或者申請(qǐng)人在中國(guó)境內(nèi)辦事機(jī)構(gòu)的承諾書； 代理人營(yíng)業(yè)執(zhí)照或者

27、申請(qǐng)人在中國(guó)境內(nèi)辦事機(jī)構(gòu)的機(jī)構(gòu)登記證明。 2) Letter of commitment of agent or applicant from its offices in China; 3) Business license of agent or registration certificate of applicants offices in Chinas.中國(guó)創(chuàng)新醫(yī)療器械特別審批程序介紹新版特別審 代理人或者申請(qǐng)人在中國(guó)境內(nèi)辦事機(jī)構(gòu)的承諾書； 210.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-declarationbyt

28、heenterprisetoguaranteethetruthfulness ofthedocumentation submitted. 11.Alldocumentsrequiredto besubmittedbyanapplicant shallbeinChinese; iftheoriginaldocumentisinaforeignlanguage,aChinese translationshallbeprovided.中國(guó)創(chuàng)新醫(yī)療器械特別審批程序介紹新版特別審10.所提交資料真實(shí)性的自我保證聲明。 10.Self-de境內(nèi)申請(qǐng)人應(yīng)當(dāng)向其所在地的省級(jí)食品藥品監(jiān)督管理部門提出創(chuàng)新醫(yī)療器械

29、特別審批申請(qǐng)，當(dāng)局于20個(gè)工作日內(nèi)出具初審意見(jiàn)。報(bào)送國(guó)家食品藥品監(jiān)督管理局。A domestic applicant shall apply for special approval of innovative medicaldevices to the local provincial food and drug supervision and administration department. And the authorities will issue a preliminary examination opinion within 20 working days, submittin

30、g to SFDA.中國(guó)創(chuàng)新醫(yī)療器械特別審批程序介紹新版特別審境內(nèi)申請(qǐng)人應(yīng)當(dāng)向其所在地的省級(jí)食品藥品監(jiān)督管理部門提出創(chuàng)新醫(yī)境外申請(qǐng)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(duì)符合本程序第四條規(guī)定的形式要求的予以受理。An overseas applicant shall apply for special approval of innovative medicaldevices to SFDA, which will be accepted in compliance with the provisions of Article IV.中國(guó)創(chuàng)新醫(yī)療器械特別審批程序介紹新版特別審境外申

31、請(qǐng)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(duì)食品藥品監(jiān)管總局醫(yī)療器械技術(shù)審評(píng)中心設(shè)立創(chuàng)新醫(yī)療器械審查辦公室，授權(quán)中國(guó)生物醫(yī)學(xué)工程學(xué)會(huì)負(fù)責(zé)對(duì)創(chuàng)新醫(yī)療器械特別審批申請(qǐng)進(jìn)行審查，并于受理后40個(gè)工作日內(nèi)出具審查意見(jiàn)。Center for Medical Device Evaluation, SFDA set up review office for innovative medical devices, authorized Chinese Society of Biomedical Engineering is responsible for a review of special ap

32、proval on innovative medical devices and will issue a preliminary examination opinion within 40 working days.中國(guó)創(chuàng)新醫(yī)療器械特別審批程序介紹新版特別審食品藥品監(jiān)管總局醫(yī)療器械技術(shù)審評(píng)中心設(shè)立創(chuàng)新醫(yī)療器械審查辦公經(jīng)創(chuàng)新醫(yī)療器械審查辦公室審查，對(duì)擬進(jìn)行特別審批的申請(qǐng)項(xiàng)目，在食品藥品監(jiān)管總局醫(yī)療器械技術(shù)審評(píng)中心網(wǎng)站將申請(qǐng)人、產(chǎn)品名稱予以公示，公示時(shí)間應(yīng)當(dāng)不少于10個(gè)工作日。對(duì)于有異議的，應(yīng)當(dāng)對(duì)相關(guān)意見(jiàn)研究后作出最終審查決定。Reviewed by the Office for Innovat

33、ive Medical Devices, for the proposed application on special approval, announce to the applicant and the product name in the website of Center for Medical Devices Evaluation of SFDA，publicity timeshall not beless than 10 working days. For any objection, it shall, after advice to related research, make a decision on the final review. 中國(guó)創(chuàng)新醫(yī)療器械特別審批程序介紹新版特別審經(jīng)創(chuàng)新醫(yī)療器械審查辦公室審查，對(duì)擬進(jìn)行特別審批的申請(qǐng)項(xiàng)目，在創(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(qǐng)人，對(duì)境內(nèi)企業(yè)的申請(qǐng)，同時(shí)抄送申請(qǐng)人所在地省級(jí)食品藥品監(jiān)督管理部門。After reviewing by the Office of Innovative Medical Devices, theapplicantwillbeinformed ofthe