【中英文对照版】医疗器械注册与备案管理办法.docx

《【中英文对照版】医疗器械注册与备案管理办法.docx》由会员分享，可在线阅读，更多相关《【中英文对照版】医疗器械注册与备案管理办法.docx（62页珍藏版）》请在得力文库 - 分享文档赚钱的网站上搜索。

1、医疗器械注册与备案管理方法Measures for the Administration of Registration and Recordation of Medical Devices【中英文对照版】发布部门：国家市场监督管理总局发文字号：国家市场监督管理总局令第47号发布日期：实施日期：效力级别：部门规章法规类别：机关工作综合规定Issuing Authority : State Administration for Market RegulationDocument Number : Order No. 47 of the State Administration for Marke

2、t RegulationDate Issued : 08-26-2021Effective Date ： 10-01-2021Level of Authority : Departmental RulesArea of Law : General Provisions on Government AffairsOrder of the State Administration for Market 国家市场叭叔管理邙局人(No. 47)(No. 47)（第47号）医疗器械注册与备案管理 方法已经2021年7月22 日市场监管总局第11次局务 会议通过，现予公布，自 2021年10月1日起施行。

3、医疗器械注册与备案管理 方法已经2021年7月22 日市场监管总局第11次局务 会议通过，现予公布，自 2021年10月1日起施行。局长张工The Measures for the Administration of Registration and Recordation of Medical Devices, as deliberated and adopted at the 11th executive meeting of the State Administration for Market Regulation on July 22, 2021, are hereby issued

4、 and shall come into force on October 1, 2021.Director: Zhang GongAugust 26, 2021August 26, 20212021年8月26日未在申请人、备案人注册地 或者生产地所在国家（地 区）上市的创新医疗器械， 不需提交相关文件。第十九条医疗器械应 当符合适用的强制性标准。 产品结构特征、预期用途、 使用方式等与强制性标准的 适用范围不一致的，申请 人、备案人应当提出不适用 强制性标准的说明，并提供 相关资料。没有强制性标准的，鼓励申 请人、备案人采用推荐性标 准。第二十条医疗器械注 册、备案工作应当遵循医疔 器械分类

5、规那么和分类目录的 有关要求。第二十一条 药品监督 管理部门持续推进审评审批 制度改革，加强医疗器械监 管科学研究，建立以技术审 评为主导，核查、检验、监 测与评价等为支撑的医疗器recordation formalities or its production country (or region).No relevant documents are required to be submitted for innovative medical devices that are not sold on the market in the country (region) where the

6、applicant or recordation party is registered or the production is carried out.Article 19 Medical devices shall comply with applicable mandatory standards. Where the structural features, expected purpose, and application methods of products, among others, are inconsistent with the scope of applicatio

7、n of the mandatory standards, the applicant or recordation party shall provide an explanation for the inapplicability of the mandatory standards and provide the relevant materials.Where there are no mandatory standards, applicants or recordation parties shall be encouraged to adopt recommended stand

8、ards.Article 20 The registration and recordation of medical devices shall comply with the rules on classification of medical devices and satisfy the relevant requirements of the classified catalogue.Article 21 Medical products administrative departments shall continuously promote the reform of the e

9、valuation and approval system, strengthen the scientific research on medical device supervision, establish a technical system for the administration of registration of medical devices dominated by technical evaluation and10supported by verification, inspection, monitoring and evaluation, optimize th

10、e evaluation and approval process, enhance the evaluation and approval capabilities, and improve the quality and efficiency of evaluation and approval.械注册管理技术体系，优化 审评审批流程，提高审评审 批能力，提升审评审批质量 和效率。Article 22 The professional technical institutions of medical devices shall establish and improve the comm

11、unication system, specify the form and content of communication, and organize communication and exchange with applicants according to the work needs.第二十二条医疗器械 专业技术机构建立健全沟通 交流制度，明确沟通交流的 形式和内容，根据工作需要 组织与申请人进行沟通交 流。Article 23 The professional technical institutions of medical devices shall, according t

12、o the work needs, establish an expert consultation system, request experts1 opinions on major issues during the process of review, verification and inspection, among others, and fully maximize the technical supporting role of experts.第二十三条医疗器械 专业技术机构根据工作需要 建立专家咨询制度，在审 评、核查、检验等过程中就 重大问题听取专家意见，充 分发挥专家

13、的技术支撑作 用。Chapter III Registration of Medical Devices第三章医疗器械注册Section 1 Development of Products第一节产品研制Article 24 Developers of medical devices shallfollow the principles of risk management, considerthe existing recognized technical merit, ensure that第二十四条医疗器械 研制应当遵循风险管理原 那么，考虑现有公认技术水all known and for

14、eseeable risks and unanticipated平，确保产品所有和可impact of the products are minimized and acceptable, and guarantee that the benefits of products from normal use are greater than risks.预见的风险以及非预期影响 最小化并可接受，保证产品 在正常使用中受益大于风 险。Article 25 The experiment activities of developing medical device products shall s

15、atisfy the requirements of relevant laws, regulations and mandatory standards of China.第二十五条从事医疗 器械产品研制实验活动，应 当符合我国相关法律、法规 和强制性标准等的要求。Article 26 An applicant or a recordation party shall develop the product technical requirements for the medical device for which an application for registration or re

16、cordation is filed.第二十六条申请人、 备案人应当编制申请注册或 者进行备案医疗器械的产品 技术要求。The product technical requirements shall mainly comprise the functional and safety indicators and testing methods that may be objectively judged for finished products of medical devices.产品技术要求主要包括医疗 器械成品的可进行客观判定 的功能性、平安性指标和检 测方法。Medical dev

17、ices shall satisfy the technical requirements for the registered or recorded products.医疗器械应当符合经注册或 者备案的产品技术要求。Article 27 An applicant or a recordation party shall develop specifications and labels of the medical device for which an application for registration or recordation is filed.第二十七条申请人、 备案人应当

18、编制申请注册或 者进行备案医疗器械的产品 说明书和标签。The specifications and labels shall satisfy the requirements of Article 39 of the Regulation on the Supervision and Administration of Medical Devices and the relevant provisions.产品说明书和标签应当符合医疗器械监督管理条例第三十九条要求以及相关规12定。Article 28 In the development of medical devices, non-cl

19、inical research on medical devices shall be carried out according to the scope of application and technical characteristics of the products.第二十八条医疗器械 研制，应当根据产品适用范 围和技术特征开展医疗器械 非临床研究。Non-clinical research shall include research on products1 chemical and physical performance, electrical safety, radiat

20、ion safety, software, biological characteristics, biological material safety, disinfection and sterilization process, animal test, and stability, among others.非临床研究包括产品化学和 物理性能研究，电气平安研 究，辐射平安研究，软件研 究，生物学特性研究，生物 源材料平安性研究，消毒、 灭菌工艺研究，动物试验研 究，稳定性研究等。To apply for registration or undergo recordation, the

21、applicant or recordation party shall submit non-clinical evidence generated in the development activities, including a summary of non-clinical research reports, research plans and research reports.申请注册或者进行备案，应 当提交研制活动中产生的非 临床证据，包括非临床研究 报告综述、研究方案和研究 报告。Article 29 The functional and safety indicators

22、and methods determined in the non-clinical research on medical devices shall be adaptable to the expected service conditions and purposes of the products, and the research specimens shall be representative and typical. If necessary, methodological verification and statistical analysis shall be condu

23、cted.第二十九条医疗器械 非临床研究过程中确定的功 能性、平安性指标及方法应 当与产品预期使用条件、目 的相适应，研究样品应当具 有代表性和典型性。必要 时，应当进行方法学验证、 统计学分析。Article 30 To apply for registration or undergo recordation, the applicant or recordation party第三十条申请注册或 者进行备案，应当按照产品13shall conduct inspection in accordance with the 技术要求进行检验,并提交technical requirements

24、for the product and submit an inspection report. Only when the inspection is passed, may clinical trial be carried out, or an application be filed and recordation formalities be检验报告。检验合格的，方 可开展临床试验或者申请注 册、进行备案。undergone.Article 31 The products to be inspected shall be able to represent the safety an

25、d effectiveness of the products for which an application for registration filed or recordation is to be undergone, and their production shall satisfy the relevant requirements of the quality management standards for production of medical devices.第三十一条检验用产 品应当能够代表申请注册或 者进行备案产品的平安性和 有效性，其生产应当符合医 疗器械生产

26、质量管理规范的 相关要求。Article 32 A product inspection report on medical devices submitted for applying for registration or undergoing recordation may be the self-inspection report of the applicant or recordation party, or an inspection report issued by a qualified medical device inspection institution on a c

27、ommissioned basis.第三十二条申请注册 或者进行备案提交的医疗器 械产品检验报告可以是申请 人、备案人的自检报告，也 可以是委托有资质的医疗器 械检验机构出具的检验报 告。Section 2 Clinical Evaluation第二节临床评价Article 33 Except for the circumstances as specified in Article 34 of these Measures, clinical evaluation shall be conducted for the registration第三十三条除本方法 第三十四条规定情形外，医 疗器

28、械产品注册、备案，应or recordation of medical device products.当进行临床评价。Clinical evaluation of medical devices means theanalysis on and evaluation of the clinical data by医疗器械临床评价是指采用14科学合理的方法对临床数据 进行分析、评价，以确认医 疗器械在其适用范围内的安 全性、有效性的活动。scientific and reasonable methods, to confirm the safety and effectiveness of m

29、edical devices within their scope of application.申请医疗器械注册，应当提 交临床评价资料。To apply for registration of medical devices, the applicant shall submit the clinical evaluation materials.第三十四条有以下情 形之一的，可以免于进行临 床评价：Article 34 Under any of the following circumstances, a clinical evaluation may be exempted:（一）工作

30、机理明确、设计 定型，生产工艺成熟，已上 市的同品种医疗器械临床应 用多年且无严重不良事件记 录，不改变常规用途的；(1) They have clear and definite working mechanisms, finalized designs and mature production techniques, the marketed medical devices of the same category have been put into clinical application for years with no record of severe adverse even

31、t, and their general purposes remain unchanged.（二）其他通过非临床评价 能够证明该医疗器械平安、 有效的。(2) Other circumstance under which the safety and effectiveness of such medical devices may be proved through non-clinical evaluation.免于进行临床评价的，可以 免于提交临床评价资料。Where clinical evaluation is exempted, submission of clinical eva

32、luation materials may be exempted.免于进行临床评价的医疗器 械目录由国家药品监督管理 局制定、调整并公布。The catalog of medical devices exempt from clinical evaluation shall be developed, adjusted and announced by the NMPA.第三十五条开展医疗 器械临床评价，可以根据产 品特征、临床风险、已有临Article 35 For clinical evaluation of medical devices, the safety and effecti

33、veness of medical devices may be proved through carrying out clinical trial according to the product15characteristics, clinical risks, existing clinical data 床数据等情形，通过开展临床试验，或者通过对同品种 医疗器械临床文献资料、临 床数据进行分析评价，证明and other circumstances, or through analysis on and evaluation of the clinical literature an

34、d clinical data of the same variety of medical devices.医疗器械的平安性、有效性。按照国家药品监督管理局的 规定，进行医疗器械临床评 价时，已有临床文献资料、 临床数据缺乏以确认产品安 全、有效的医疗器械，应当 开展临床试验。国家药品监督管理局制定医 疗器械临床评价指南，明确 通过同品种医疗器械临床文 献资料、临床数据进行临床 评价的要求，需要开展临床 试验的情形，临床评价报告 的撰写要求等。When clinical evaluation of medical devices is conducted in accordance with

35、 the rules of the NMPA, clinical trials shall be carried out for medical devices for which the existing clinical literature and clinical data are insufficient to confirm the safety and effectiveness of the products.The NMPA shall develop guidelines for the clinical evaluation of medical devices to s

36、pecify the requirements for clinical evaluation through clinical literature and clinical data of the same variety of medical devices, the circumstances under which clinical trials need to be carried out, and the requirements for preparing clinical evaluation reports, among others.第三十六条通过同品 种医疗器械临床文献

37、资料、Article 36 Where clinical evaluation is carried out according to the clinical literature and clinical data of the same variety of medical devices, the clinical临床数据进行临床评价的， 临床评价资料包括申请注册 产品与同品种医疗器械的对 比，同品种医疗器械临床数 据的分析评价，申请注册产 品与同品种产品存在差异时临床数据进行临床评价的， 临床评价资料包括申请注册 产品与同品种医疗器械的对 比，同品种医疗器械临床数 据的分析评价，申请

38、注册产 品与同品种产品存在差异时evaluation materials shall include the comparison between the product for which an application for registration is filed and the same variety of medical devices, the analysis on and evaluation of the clinical data of the same variety of medical devices, the scientific evidence and ev

39、aluation conclusions when there are differences between的科学证据以及评价结论等 内容。的科学证据以及评价结论等 内容。the product for which an application for registration is filed and the same variety of medical devices, and other contents.Where clinical evaluation is carried out through 通过临床试验开展临床评价16的，临床评价资料包括临床 试验方案、伦理委员会意 见、

40、知情同意书、临床试验 报告等。clinical trials, the clinical evaluation materials shall include clinical trial plans, opinions of the ethics committee, informed consent and clinical trial reports, among others.Article 37 Clinical trials of medical devices shall第三十七条开展医疗 器械临床试验，应当按照医 疗器械临床试验质量管理规 范的要求，在具备相应条件 并按照规定备

41、案的医疗器械 临床试验机构内进行。临床 试验开始前，临床试验申办 者应当向所在地省、自治 区、直辖市药品监督管理部 门进行临床试验备案。临床 试验医疗器械的生产应当符 合医疗器械生产质量管理规 范的相关要求。第三十七条开展医疗 器械临床试验，应当按照医 疗器械临床试验质量管理规 范的要求，在具备相应条件 并按照规定备案的医疗器械 临床试验机构内进行。临床 试验开始前，临床试验申办 者应当向所在地省、自治 区、直辖市药品监督管理部 门进行临床试验备案。临床 试验医疗器械的生产应当符 合医疗器械生产质量管理规 范的相关要求。be carried out in clinical trial inst

42、itutions for medical devices that meet corresponding conditions and have undergone the recordation formalities as required in accordance with the requirements of the quality management standards for the clinical trials of medical devices. Before the start of a clinical trial, the applicant for a cli

43、nical trial shall undergo the formalities for recordation of clinical trial with the medical products administrative department of the province, autonomous region, or municipality directly under the Central Government where it is located. The production of medical devices to be put in clinical trial

44、 shall satisfy the relevant requirements of the quality management standards for production of medical devices.临床试验审批是指国家药品 监督管理局根据申请人的申 请，对拟开展临床试验的医 疗器械的风险程度、临床试 验方案、临床受益与风险对比分析报告等进行综合分 析，以决定是否同意开展临 床试验的过程。Article 38 Clinical trials of Class III medical 第二十八条 第二类医 devices which may pose relatively

45、high risks to 疗器械进行临床试验对人体 human bodies shall be subject to the approval of 具有较高风险的，应当经国 the NMPA.家药品监督管理局批准。The examination and approval of clinical trials means the process whereby the NMPA, upon the application of applicants, comprehensively analyzes the degree of risks in the medical devices to

46、be put in clinical trials, the clinical trial plans, and the clinical benefit and risk comparison and analysis reports to decide whether to approve the clinical trials of the medical devices.17需进行临床试验审批的第三 类医疗器械目录由国家药品 监督管理局制定、调整并公 布。需进行临床试验审批的 第三类医疗器械临床试验应 在符合要求的三级甲等医疗 机构开展。需进行临床试验审批的第三 类医疗器械目录由国家药

47、品 监督管理局制定、调整并公 布。需进行临床试验审批的 第三类医疗器械临床试验应 在符合要求的三级甲等医疗 机构开展。第三十九条需进行医 疗器械临床试验审批的，申 请人应当按照相关要求提交 综述资料、研究资料、临床 资料、产品说明书和标签样 稿等申请资料。The catalogue of Class III medical devices subject to examination and approval for clinical trials shall be developed, adjusted and published by the NMPA. The clinical tria

48、ls of Class III medical devices whose clinical trials are subject to examination and approval shall be carried out in qualified medical institutions of Grade III and Level A.第四十条国家局器械 审评中心对受理的临床试验 申请进行审评。对临床试验 申请应当自受理申请之日60 日内作出是否同意的决定， 并通过国家局器械审评中心 网站通知申请人。逾期未通 知的，视为同意。Article 39 Where the clinical tri