中國創(chuàng)新醫(yī)療器械特別審批程序介紹 顧漢卿

1、中國創(chuàng)新醫(yī)療器械中國創(chuàng)新醫(yī)療器械特別審批程序介紹特別審批程序介紹Introduction to Special Approval Procedure on Chinas Innovative Medical Devices中國生物醫(yī)學工程學會中國生物醫(yī)學工程學會 顧漢卿顧漢卿Chinese Society of Biomedical Engineering Gu Hanqing 隨著科學技術(shù)的進步，隨著科學技術(shù)的進步，醫(yī)療器械在臨床疾病醫(yī)療器械在臨床疾病的預防、診斷、治療的預防、診斷、治療中的作用越來越顯得中的作用越來越顯得重要。為了鼓勵醫(yī)療重要。為了鼓勵醫(yī)療器械的研究與創(chuàng)新，器械的研究與創(chuàng)新

2、，讓更多創(chuàng)新的高科技讓更多創(chuàng)新的高科技醫(yī)療器械快速受惠于醫(yī)療器械快速受惠于普通百姓，中國食品普通百姓，中國食品藥品監(jiān)督管理局頒布藥品監(jiān)督管理局頒布了了創(chuàng)新醫(yī)療器械特創(chuàng)新醫(yī)療器械特別審批程序（試別審批程序（試行）行）。 With the progress of science and technology, medical devices in the role of clinical disease prevention, diagnosis, and treatment is more and more important. To encourage research and innovat

3、ion in medical devices, so that more innovative high-tech medical devices to rapidly benefit ordinary people, the State Food and Drug Administration (SFDA) issued Special Approval Procedure on Innovative Medical Devices (trial). 一、哪些醫(yī)療器一、哪些醫(yī)療器械產(chǎn)品屬于創(chuàng)新械產(chǎn)品屬于創(chuàng)新醫(yī)療器械，可以醫(yī)療器械，可以申報特別審批。申報特別審批。 I. Which produ

4、cts are innovative medical devices that can declare special approval? 同時符合下列同時符合下列四點的產(chǎn)品屬四點的產(chǎn)品屬于創(chuàng)新醫(yī)療器于創(chuàng)新醫(yī)療器械范圍。械范圍。 The products meeting the following four points are innovative range of medical devices. 1. 1.申請者在中國申請者在中國依法擁有申報產(chǎn)依法擁有申報產(chǎn)品核心技術(shù)的發(fā)品核心技術(shù)的發(fā)明專利權(quán)，或者明專利權(quán)，或者依法通過受讓取依法通過受讓取得在中國發(fā)明專得在中國發(fā)明專利權(quán)或其使用權(quán)；利權(quán)

5、或其使用權(quán)；或者核心技術(shù)發(fā)或者核心技術(shù)發(fā)明專利的申請已明專利的申請已由國務(wù)院專利行由國務(wù)院專利行政部門公開。政部門公開。 1）The applicant according to the law have the right of invention patent on declaring core technology in China, or according to the law through the transferee obtain the patent right for invention or the right to use in China; or the applic

6、ation of invention patent on core technology has been published by the patent administration department under the State Council. 2. 2.產(chǎn)品主要工產(chǎn)品主要工作原理作原理/ /作用機作用機理為國內(nèi)首創(chuàng)，理為國內(nèi)首創(chuàng)，產(chǎn)品性能或者安產(chǎn)品性能或者安全性與同類產(chǎn)品全性與同類產(chǎn)品比較有根本性改比較有根本性改進，技術(shù)上處于進，技術(shù)上處于國際領(lǐng)先水平。國際領(lǐng)先水平。 2. The main working principle / mechanism of products ar

7、e the first in the country. Product performance or safety compared with similar product has a fundamental improvement, with technically a leading international level. 3. 3.該產(chǎn)品具有該產(chǎn)品具有顯著的臨床應(yīng)顯著的臨床應(yīng)用價值。用價值。 3. The product has significant value in clinical application. 4. 4.已完成該產(chǎn)已完成該產(chǎn)品的前期研究并品的前期研究并具有基本定型

8、產(chǎn)具有基本定型產(chǎn)品，研究過程真品，研究過程真實和受控，研究實和受控，研究數(shù)據(jù)完整和可溯數(shù)據(jù)完整和可溯源。源。 4. Have finished the preliminary research of the product and finalized the designed product. The process of study is real and controlled, with data integrity and traceability. 二、創(chuàng)新醫(yī)療二、創(chuàng)新醫(yī)療器械特別審批器械特別審批獲得通過，有獲得通過，有哪些優(yōu)惠政策哪些優(yōu)惠政策? ? II. What are the

9、preferential policies for passing the special approval of innovative medical devices? 申請人所在地食申請人所在地食品藥品監(jiān)督管理品藥品監(jiān)督管理部門應(yīng)當指定專部門應(yīng)當指定專人，應(yīng)申請人的人，應(yīng)申請人的要求及時溝通、要求及時溝通、提供指導。在接提供指導。在接到申請人質(zhì)量管到申請人質(zhì)量管理體系檢查（考理體系檢查（考核）申請后，應(yīng)核）申請后，應(yīng)當予以優(yōu)先辦理。當予以優(yōu)先辦理。 The local food and drug supervision and administration authority shall

10、appoint someone, at the request of the applicant, provide guidance for timely communication. Upon receipt of the applicant to check the quality management system (assessment) application, should be given priority. 醫(yī)療器械檢測機醫(yī)療器械檢測機構(gòu)在進行注冊檢構(gòu)在進行注冊檢測時，應(yīng)當及時測時，應(yīng)當及時對生產(chǎn)企業(yè)提交對生產(chǎn)企業(yè)提交的產(chǎn)品標準或技的產(chǎn)品標準或技術(shù)要求進行預評術(shù)要求進行預評價，

11、對存在問題價，對存在問題的，應(yīng)當及時向的，應(yīng)當及時向生產(chǎn)企業(yè)提出修生產(chǎn)企業(yè)提出修改建議。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 problems of the companies, shall be timely proposed amendments.

12、 醫(yī)療器械檢測機構(gòu)醫(yī)療器械檢測機構(gòu)應(yīng)當在接受樣品后應(yīng)當在接受樣品后優(yōu)先進行醫(yī)療器械優(yōu)先進行醫(yī)療器械注冊檢測，并出具注冊檢測，并出具檢測報告檢測報告。 Testing institution for medical devices shall make a registration test for medical devices in priority after accepting samples , and issue the report. 創(chuàng)新醫(yī)療器械的臨創(chuàng)新醫(yī)療器械的臨床試驗應(yīng)當按照醫(yī)床試驗應(yīng)當按照醫(yī)療器械臨床試驗相療器械臨床試驗相關(guān)規(guī)定的要求進行，關(guān)規(guī)定的要求進行，食品藥品監(jiān)督管理

13、食品藥品監(jiān)督管理部門應(yīng)當根據(jù)臨床部門應(yīng)當根據(jù)臨床試驗的進程進行監(jiān)試驗的進程進行監(jiān)督檢查。督檢查。 Clinical trials of innovative medical devices shall be in accordance with the requirements of related regulations on clinical trials of medical devices. The food and drug supervision and administration department shall make supervision and inspection

14、according to the process of clinical trials. 在產(chǎn)品注冊申請受理在產(chǎn)品注冊申請受理前以及技術(shù)審評過程前以及技術(shù)審評過程中，食品藥品監(jiān)管總中，食品藥品監(jiān)管總局醫(yī)療器械技術(shù)審評局醫(yī)療器械技術(shù)審評中心應(yīng)當指定專人，中心應(yīng)當指定專人，應(yīng)申請人的要求及時應(yīng)申請人的要求及時溝通、提供指導，共溝通、提供指導，共同討論相關(guān)技術(shù)問題。同討論相關(guān)技術(shù)問題。 Before accepting an application for registration of the product and in the process of technical review, Cent

15、er for Medical Device Evaluation of SFDA shall designate someone, at the request of the applicant, provide guidance for timely communication and discuss the related technical problems. 企業(yè)可以通過申請與審企業(yè)可以通過申請與審評中心指定專人就以下評中心指定專人就以下問題進行溝通交流：問題進行溝通交流： 1. 1. 重大技術(shù)問題；重大技術(shù)問題； 2. 2. 重大安全性問題；重大安全性問題； 3. 3. 臨床試驗方案

16、：臨床試驗方案： 4. 4. 階段性臨床試驗結(jié)果階段性臨床試驗結(jié)果 的總結(jié)與評價；的總結(jié)與評價； 5. 5. 其他需要溝通交流的其他需要溝通交流的 重要問題。重要問題。 Enterprises can apply for communicating with designated person of Evaluation Center on the following issues: 1. Major technical problems; 2. Major safety issues; 3. Clinical trial schemes; 4. Periodic summary and ev

17、aluation of the results of clinical trials; 5. The other important issues that need to communicate. 受理創(chuàng)新醫(yī)療器受理創(chuàng)新醫(yī)療器械注冊申請后，械注冊申請后，應(yīng)當將該注冊申應(yīng)當將該注冊申請項目標記為請項目標記為“創(chuàng)新醫(yī)療器創(chuàng)新醫(yī)療器械械”，并及時進，并及時進行注冊申報資料行注冊申報資料流轉(zhuǎn)。流轉(zhuǎn)。 After accepting the application for registration of innovative medical devices, the registration item

18、s shall be marked as innovative medical devices, and register to declare information flow in a timely manner. 已受理注冊申報已受理注冊申報的創(chuàng)新醫(yī)療器械，的創(chuàng)新醫(yī)療器械，食品藥品監(jiān)管總食品藥品監(jiān)管總局醫(yī)療器械技術(shù)局醫(yī)療器械技術(shù)審評中心應(yīng)當優(yōu)審評中心應(yīng)當優(yōu)先進行技術(shù)審評；先進行技術(shù)審評；技術(shù)審評結(jié)束后，技術(shù)審評結(jié)束后，食品藥品監(jiān)管總食品藥品監(jiān)管總局優(yōu)先進行行政局優(yōu)先進行行政審批。審批。 For the innovative medical devices that have been d

19、eclared to accept the registration, Center for Medical Devices Evaluation, SFDA should give priority to the technical review; after the technical evaluation, SFDA is priority to administrative approval. 三、申報創(chuàng)新醫(yī)三、申報創(chuàng)新醫(yī)療器械特別審批療器械特別審批應(yīng)準備哪些資料應(yīng)準備哪些資料? ? III. What information should be ready for declaring

20、 the special approval of innovative medical devices? 1. 1.申請人企申請人企業(yè)法人資格證業(yè)法人資格證明文件；明文件； 2. 2.產(chǎn)品知識產(chǎn)品知識產(chǎn)權(quán)情況及證產(chǎn)權(quán)情況及證明文件；明文件； 3. 3.產(chǎn)品研發(fā)產(chǎn)品研發(fā)過程及結(jié)果的過程及結(jié)果的綜述；綜述； 1.Legal person qualification certificates of the applicant; 2.Intellectual property information and supporting documents of products; 3.Summary of

21、product development process and results; 4.4.產(chǎn)品技術(shù)文產(chǎn)品技術(shù)文 件，至少應(yīng)當件，至少應(yīng)當 包括：包括： 產(chǎn)品的預期用產(chǎn)品的預期用 途；途； 產(chǎn)品工作原理產(chǎn)品工作原理/ / 作用機理；作用機理； 4.Technical documents of products should include at least 1) The intended use of products; 2) The working principle and mechanism of products; 產(chǎn)品主要技術(shù)指產(chǎn)品主要技術(shù)指標及確定依據(jù)，主標及確定依據(jù)，主要原材料、關(guān)

22、鍵元要原材料、關(guān)鍵元器件的指標要求，器件的指標要求，主要生產(chǎn)工藝過程主要生產(chǎn)工藝過程及流程圖，主要技及流程圖，主要技術(shù)指標的檢驗方法。術(shù)指標的檢驗方法。 3) The main technical indicators and basis of products, the main raw materials, the index requirements of key components, the main production process and flow chart, and the testing method of main technical indicators. 5. 5

23、.產(chǎn)品創(chuàng)新的證明產(chǎn)品創(chuàng)新的證明性文件，至少應(yīng)當性文件，至少應(yīng)當包括：包括： 信息或者專利信息或者專利檢索機構(gòu)出具的檢索機構(gòu)出具的查新報告；查新報告； 核心刊物公開核心刊物公開發(fā)表的能夠充分發(fā)表的能夠充分說明產(chǎn)品臨床應(yīng)說明產(chǎn)品臨床應(yīng)用價值的學術(shù)論用價值的學術(shù)論文、專著及文件文、專著及文件綜述；綜述； 5. Documented evidence of product innovation include at least 1) The testing report issued by information or patent search agency; 2) Academic papers,

24、 monographs and documents review published in core journals that can fully explain the clinical application value. 國內(nèi)外已上市國內(nèi)外已上市同類產(chǎn)品應(yīng)用情同類產(chǎn)品應(yīng)用情況的分析及對比況的分析及對比（如有）；（如有）； 產(chǎn)品的創(chuàng)新內(nèi)產(chǎn)品的創(chuàng)新內(nèi)容及在臨床應(yīng)用容及在臨床應(yīng)用的顯著價值。的顯著價值。 3) Analysis and comparison in the application of similar products already listed on the market

25、at home and abroad (if any); 4) The innovation content of products and significant value in clinical application. 6. 6.產(chǎn)品安全風險產(chǎn)品安全風險管理報告。管理報告。 7. 7.產(chǎn)品說明書。產(chǎn)品說明書。 8. 8.其他證明產(chǎn)品其他證明產(chǎn)品符合創(chuàng)新醫(yī)療器符合創(chuàng)新醫(yī)療器械要求的資料。械要求的資料。 6. A report on safety and risk management of products. 7. Product Manual. 8. Other supporting

26、information that can prove to meet the requirements of innovative medical devices. 9. 9.境外申請人應(yīng)當委境外申請人應(yīng)當委托中國境內(nèi)的企業(yè)法托中國境內(nèi)的企業(yè)法人作為代理人或者由人作為代理人或者由其在中國境內(nèi)的辦事其在中國境內(nèi)的辦事機構(gòu)提出申請，并提機構(gòu)提出申請，并提交以下文件：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 Ch

27、ina, apply for and submit the following documents: 境外申請人委境外申請人委托代理人或者其托代理人或者其在中國境內(nèi)辦事在中國境內(nèi)辦事機構(gòu)辦理創(chuàng)新醫(yī)機構(gòu)辦理創(chuàng)新醫(yī)療器械特別審批療器械特別審批申請的委托書；申請的委托書； 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

28、. 代理人或者申代理人或者申請人在中國境內(nèi)辦請人在中國境內(nèi)辦事機構(gòu)的承諾書；事機構(gòu)的承諾書； 代理人營業(yè)執(zhí)代理人營業(yè)執(zhí)照或者申請人在中照或者申請人在中國境內(nèi)辦事機構(gòu)的國境內(nèi)辦事機構(gòu)的機構(gòu)登記證明。機構(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.10.10.所提交資料真所提交資料真實性的自我保實性的自我保證聲

29、明。證聲明。11.11.申報資料應(yīng)當申報資料應(yīng)當使用中文。原使用中文。原文為外文的，文為外文的，應(yīng)當有中文譯應(yīng)當有中文譯本。本。 10.Self-declaration by the enterprise to guarantee the truthfulness of the documentation submitted. 11.All documents required to be submitted by an applicant shall be in Chinese; if the original document is in a foreign language, a Chi

30、nese translation shall be provided. 境內(nèi)申請人應(yīng)當境內(nèi)申請人應(yīng)當向其所在地的省向其所在地的省級食品藥品監(jiān)督級食品藥品監(jiān)督管理部門提出創(chuàng)管理部門提出創(chuàng)新醫(yī)療器械特別新醫(yī)療器械特別審批申請，當局審批申請，當局于于2020個工作日內(nèi)個工作日內(nèi)出具初審意見。出具初審意見。報送國家食品藥報送國家食品藥品監(jiān)督管理局。品監(jiān)督管理局。 A domestic applicant shall apply for special approval of innovative medical devices to the local provincial food and drug

31、 supervision and administration department. And the authorities will issue a preliminary examination opinion within 20 working days, submitting to SFDA. 境外申請人應(yīng)當境外申請人應(yīng)當向食品藥品監(jiān)管向食品藥品監(jiān)管總局提出創(chuàng)新醫(yī)總局提出創(chuàng)新醫(yī)療器械特別審查，療器械特別審查，對符合本程序第對符合本程序第四條規(guī)定的形式四條規(guī)定的形式要求的予以受理。要求的予以受理。 An overseas applicant shall apply for specia

32、l approval of innovative medical devices to SFDA, which will be accepted in compliance with the provisions of Article IV. 食品藥品監(jiān)管總局食品藥品監(jiān)管總局醫(yī)療器械技術(shù)審評醫(yī)療器械技術(shù)審評中心設(shè)立創(chuàng)新醫(yī)療中心設(shè)立創(chuàng)新醫(yī)療器械審查辦公室，器械審查辦公室，授權(quán)中國生物醫(yī)學授權(quán)中國生物醫(yī)學工程學會負責對創(chuàng)工程學會負責對創(chuàng)新醫(yī)療器械特別審新醫(yī)療器械特別審批申請進行審查，批申請進行審查，并于受理后并于受理后4040個工個工作日內(nèi)出具審查意作日內(nèi)出具審查意見。見。 Center for

33、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 approval on innovative medical devices and will issue a preliminary examination opinion within 40 working days. 經(jīng)創(chuàng)新醫(yī)療器械審查辦經(jīng)

34、創(chuàng)新醫(yī)療器械審查辦公室審查，對擬進行特公室審查，對擬進行特別審批的申請項目，在別審批的申請項目，在食品藥品監(jiān)管總局醫(yī)療食品藥品監(jiān)管總局醫(yī)療器械技術(shù)審評中心網(wǎng)站器械技術(shù)審評中心網(wǎng)站將申請人、產(chǎn)品名稱予將申請人、產(chǎn)品名稱予以公示，公示時間應(yīng)當以公示，公示時間應(yīng)當不少于不少于1010個工作日。對個工作日。對于有異議的，應(yīng)當對相于有異議的，應(yīng)當對相關(guān)意見研究后作出最終關(guān)意見研究后作出最終審查決定。審查決定。 Reviewed by the Office for Innovative Medical Devices, for the proposed application on special app

35、roval, announce to the applicant and the product name in the website of Center for Medical Devices Evaluation of SFDA，publicity time shall not be less than 10 working days. For any objection, it shall, after advice to related research, make a decision on the final review. 創(chuàng)新醫(yī)療器械審創(chuàng)新醫(yī)療器械審查辦公室作出審查辦公室作出審查決定后，將審查決定后，將審查結(jié)果書面通知查結(jié)果書面通知申請人，對境內(nèi)申請人，對境內(nèi)企業(yè)的申請，同企業(yè)的申請，同時抄送申請人所時抄送申請人所在地省級食品藥在地省級食品藥品監(jiān)督管理部門。品監(jiān)督管理部門。 After rev