【中英文对照版】医疗器械说明书和标签管理规定.docx

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1、医疗器械说明书和标签管理规定Provisions on the Administration of Instructions and Labels of Medical Devices【中英文对照版】发布部门：国家食品药品监督管理总局（已撤销）发文字号:发文字号:中华人民共和国国家食品药品监督管理总局令第6号发布日期：2014.07.30 实施日期：2014.10.01 效力级别：部门规章法规类别：医疗保健Issuing Authority : China Food and Drug Administration (dissolved)Document Number : Order No. 6

2、 of the China Food and Drug AdministrationDate Issued ： 07-30-2014Effective Date ： 10-01-2014Level of Authority : Departmental RulesArea of Law : Health CareOrder of the China Food and Drug Administration国家食品药品监督管理总局 令(No. 6)（第6号）The Provisions on the Administration of Instructions and Labels of Med

3、ical Devices, as deliberated and adopted at the executive meeting of the China Food and Drug Administration (“CFDA) on June 27, 2014, are hereby issued and shall come into force on October 1,2014.医疗器械说明书和标签管 理规定已于2014年6月 27日经国家食品药品监督 管理总局局务会议审议通 过，现予公布，自2014年 10月1日起施行。Director: Zhang Yong局长 张勇July 3

4、0, 20142014年7月30日率的;(4) Comparison with the products of other enterprises in respect of their effects and safety;（四）与其他企业产品的功 效和平安性相比拟的；(5) Promises such as insured by insurance company” and “refund guaranteed;（五）含有“保险公司保 险”、“无效退款”等承诺 性语言的；(6) Proofs or recommendations by use of the name and image o

5、f any entity or individual;（六）利用任何单位或者个 人的名义、形象作证明或者 推荐的；(7) Misleading expressions that may induce readers to feel they are suffering from a disease, or they will suffer from a disease or the disease will deteriorate if they do not resort to the medical device, and other false, exaggerated or misle

6、ading contents; and（七）含有误导性说明，使 人感到已经患某种疾病，或 者使人误解不使用该医疗器 械会患某种疾病或者加重病 情的表述，以及其他虚假、 夸大、误导性的内容；(8) Other contents prohibited by laws or regulations.（八）法律、法规规定禁止 的其他内容。Article 15 The instruction of a medical device shall be submitted by the registration applicant or the party undergoing recordation of

7、 the medical device to the food and drug supervision and administration department for examination or recordation when it or第十五条医疗器械说 明书应当由注册申请人或者 备案人在医疗器械注册或者 备案时，提交食品药品监督he applies for registration or undergoes recordation of 管理部门审查或者备案，提the medical device. The contents of the submitted instructio

8、n shall be consistent with other registration or recordation materials.交的说明书内容应当与其他 注册或者备案资料相符合。Article 16 The contents in the instruction of a medicaldevice that has been subject to registration第十六条经食品药品 监督管理部门注册审查的医10疗器械说明书的内容不得擅 自更改。examination of the food and drug supervision and administration

9、department shall not be modified without authorization.已注册的医疗器械发生注册 变更的，申请人应当在取得 变更文件后，依据变更文件 自行修改说明书和标签。说明书的其他内容发生变化 的，应当向医疗器械注册的 审批部门书面告知，并提交 说明书更改情况比照说明等 相关文件。审批部门自收到 书面告知之日起20个工作 日内未发出不予同意通知件 的，说明书更改生效。Where a registered medical device is under modification of registration, the applicant shall,

10、after obtaining the documents on modification, modify the instruction and label on the basis of such documents.Where any other content of the instruction changes, the approval authority for the registration of medical devices shall be notified of such change in writing, and a comparative description

11、 on modifications of the instruction and other relevant documents shall also be submitted. Where the approval authority does not issue a notice for disapproval within 20 working days after receipt of the written notification, the modification of the instruction shall take effect.第十七条已备案的医 疗器械，备案信息表中

12、登载 内容、备案产品技术要求以 及说明书其他内容发生变化 的，备案人自行修改说明书 和标签的相关内容。Article 17 For a medical device that has been subject to recordation, where any content of the recordation information sheet, product technical requirement or any other content of the instruction changes, the party undergoing recordation shall modif

13、y the relevant content of the instruction and label.第十八条说明书和标 签不符合本规定要求的，由 县级以上食品药品监督管理 部门按照医疗器械监督管 理条例第六十七条的规定 予以处分。Article 18 Where any instruction or label fails to meet the requirements of these Provisions, a food and drug supervision and administration department at or above the county level sh

14、all impose penalties in accordance with Article 67 of the Regulation on the Supervision and Administration of Medical Devices.11第十九条本规定自2014年10月1日起施行。2004年7月8日公布的医疗器械说明书、标签和 包装标识管理规定（原国 家食品药品监督管理局令第121210号）同时废止。Article 19 These Provisions shall come into force on October 1, 2014. The Provisions on t

15、he Administration of Manuals, Labels and Package Marks of Medical Devices (Order No. 10, SFDA) issued on July 8, 2004 shall be repealed concurrently.Provisions on the Administration of Instructions 医疗器械说明书和标签管理 and Labels of Medical Devices规定This Regulation is developed for purposes of regulating th

16、e instructions and labels of medical devices and ensuring the safety in the use of medical devices.Article 1 The medical devices sold or used within the territory of the Peoples Republic of China shall be accompanied by instructions and labels in accordance with these Provisions.Article 2 The term i

17、nstructions of medical devices” refers to those technical documents that are formulated by medical device registrants or the parties undergoing recordation of medical devices and are provided for users together with products, and can cover the basic information about the safety and validity of produ

18、cts and be used for guiding the correct installation, debugging, operation, use, repair and maintenance of products.The term labels of medical devices refers to the written descriptions, graphics and symbols that are attached to medical devices or their packages and are used for identifying the prod

19、uct features and indicating the safety warnings.第一条为规范医疗器 械说明书和标签，保证医疗 器械使用的平安，根据医 疗器械监督管理条例，制 定本规定。第二条凡在中华人民 共和国境内销售、使用的医 疗器械，应当按照本规定要 求附有说明书和标签。第三条医疗器械说明书是指由医疗器械注册人或 者备案人制作，随产品提供 给用户，涵盖该产品平安有 效的基本信息，用以指导正 确安装、调试、操作、使 用、维护、保养的技术文 件。医疗器械标签是指在医疗器 械或者其包装上附有的用于 识别产品特征和标明平安警 示等信息的文字说明及图 形、符号。第四条医疗器械说明Ar

20、ticle 3 The contents in the instructions and labels ofmedical devices shall be true, complete, accurate and scientific, and consistent with the product features.书和标签的内容应当科学、 真实、完整、准确，并与产 品特性相一致。The contents in the instruction and label of a medical device shall keep consistent with the relevant cont

21、ents subject to registration or recordation.医疗器械说明书和标签的内 容应当与经注册或者备案的 相关内容一致。The contents in the label of a medical device shall be consistent with those in the instruction.医疗器械标签的内容应当与 说明书有关内容相符合。第五条医疗器械说明 书和标签对疾病名称、专业 名词、诊断治疗过程和结果 的表述，应当采用国家统一Article 4 For expressions on the names of diseases, pro

22、fessional terms, and the process and result of diagnosis and treatment, the instruction and label of a medical device shall use the terminologies uniformly released or regulated by the state, and the units of 发布或者规范的专用词汇,measurement shall meet the relevant national standards.Article 5 The symbol or

23、color for identification used in the instruction and label of a medical device shall comply with the provisions of the relevant national standards; in the absence of relevant standards, the symbol or color for identification shall be indicated in the instruction.Article 6 Each minimum sales unit of

24、a medical device shall be attached with an instruction.度量衡单位应当符合国家相 关标准的规定。第六条医疗器械说明 书和标签中使用的符号或者 识别颜色应当符合国家相关 标准的规定；无相关标准规 定的，该符号及识别颜色应 当在说明书中描述。第七条医疗器械最小 销售单元应当附有说明书。医疗器械的使用者应当按照 说明书使用医疗器械。The user of a medical device shall use the medical device in accordance with the instruction.第八条医疗器械的产 品名称应当使

25、用通用名称， 通用名称应当符合国家食品 药品监督管理总局制定的医 疗器械命名规那么。第二类、 第三类医疗器械的产品名称 应当与医疗器械注册证中的 产品名称一致。产品名称应当清晰地标明在 说明书和标签的显著位置。第九条医疗器械说明 书和标签文字内容应当使用 中文，中文的使用应当符合 国家通用的语言文字规范。 医疗器械说明书和标签可以 附加其他文种，但应当以中 文表述为准。医疗器械说明书和标签中的 文字、符号、表格、数字、 图形等应当准确、清晰、规 范。(1) Product name, model and specification;（一）产品名称、型号、规 格；A medical device

26、 shall have the common name as its product name. A generic name shall comply with the naming rules for medical devices formulated by the CFDA. The product names of the medial devices of Class II and Class III shall be consistent with the product names indicated in their medical device registration c

27、ertificates.The product names shall be clearly indicated at the eye-catching places of the instructions and labels.Article 7 The language used in the instructions and labels of medical devices shall be Chinese, and the use of Chinese shall meet the requirements for standard spoken and written Chines

28、e language. The instructions and labels of medical devices may be accompanied by any other language, but the Chinese version shall prevail.The characters, symbols, tables, figures, graphics, etc. used in the instructions and labels of medical devices shall be accurate, clear and standard.Article 8 T

29、he instruction of a medical device shall 第十条医疗器械说明generally include:书一般应当包括以下内容：（二）注册人或者备案人的The name, domicile, contact information and after-名称、住所、联系方式及售 后服务单位，进口医疗器械 还应当载明代理人的名称、 住所及联系方式；sales service agencies of the registrant or the party undergoing recordation of the medical device, as well as

30、the name, domicile and contact information of the agency if it is an imported medical device;（三）生产企业的名称、住 所、生产地址、联系方式及 生产许可证编号或者生产备 案凭证编号，委托生产的还 应当标注受托企业的名称、（三）生产企业的名称、住 所、生产地址、联系方式及 生产许可证编号或者生产备 案凭证编号，委托生产的还 应当标注受托企业的名称、(2) The name, domicile, production address and contact information of the produ

31、ction enterprise and the serial number of its production license or production recordation certificate, as well as the name, domicile and production address of the entrusted住所、生产地址、生产许可 证编号或者生产备案凭证编 号；住所、生产地址、生产许可 证编号或者生产备案凭证编 号；enterprise and the serial number of its production license or productio

32、n recordation certificate if the medical device is entrusted for production;The serial number of the medical device (四)医疗器械注册证编号 registration certificate or the recordation certificate;或者备案凭证编号；(3) The serial number of product technical (五)产品技术要求的编requirements;号；(4) Products performance, main struct

33、ure or (六)产品性能、主要结构 ingredients and scope of application;组成或者成分、适用 范围；（七）禁忌症、考前须知、 警示以及提示的内容；（七）禁忌症、考前须知、 警示以及提示的内容；(5) Contraindications, matters for attention, and other warnings or precautions;（A）安装和使用说明或者 图示，由消费者个人自行使 用的医疗器械还应当具有安 全使用的特别说明；（A）安装和使用说明或者 图示，由消费者个人自行使 用的医疗器械还应当具有安 全使用的特别说明；(6) Inst

34、ructions for installation and use and the drawings thereof, as well as the special instructions for safe use if the medical device is to be used by consumers themselves.（九）产品维护和保养方 法，特殊储存、运输条件、 方法；(7) Products maintenance methods, and conditions and methods for special storage and transportation;Pro

35、duction date and service life or expiration (十)生产日期，使用期限date;或者失效日期；（十一）配件清单，包括配 件、附属品、损耗品更换周 期以及更换方法的说明等；(8) List of accessory parts, including a description on the replacement cycle and replacement method of accessory parts, accessories, consumables;（十二）医疗器械标签所用 的图形、符号、缩写等内容 的解释；（十二）医疗器械标签所用 的图形、符

36、号、缩写等内容 的解释；(9) Interpretations on graphics, symbols and abbreviations, etc. used in the label of the medical device;The date when the instruction is prepared or (十三)说明书的编制或者 revised; and修订日期；(14) Other contents that shall be indicated.（十四）其他应当标注的内 容。第十一条医疗器械说 明书中有关考前须知、警示 以及提示性内容主要包括：Article 11 The

37、 matters for attention, warnings and precautions in the instruction of a medical device shall mainly include:(1) Users of such product;（一）产品使用的对象;(2) Potential safety hazards and use restrictions;（二）潜在的平安危害及使 用限制；（四）必要的监测、评估、 控制手段；（五）一次性使用产品应当 注明“一次性使用”字样或 者符号，已灭菌产品应当注 明灭菌方式以及灭菌包装损 坏后的处理方法，使用前需Prote

38、ction measures for operators and users as well (二)产品在正确使用过程 as emergency and correction measures that shall be 中出现意外时，对操作者、 taken when any accident occurs in the proper use of 使用者 的保护措施以及应当 Products;采取的应急和纠正措施；(3) Necessary monitoring, assessment, control means;The characters or marks such as single

39、-use that shall be indicated for a single-use product, the sterilization method and the method for disposing in the case of damage to the sterilization package that shall be indicated for a sterilized product, or the disinfection or sterilization method that shall beindicated if disinfection or ster

40、ilization is required before the use;(4) The requirements, usage and precautions for joint use that shall be indicated if the product needs to be installed or jointly operated together with other medical devicesPossible mutual disturbances and possible dangers when the product is used together with

41、other products;(5) Adverse events that may be brought along with the use of the product or the ingredients of the product or the supplementary materials thereof that may cause side effects;Matters that need attention during the disposal of an abandoned medical device, and the corresponding treatment

42、 methods that shall be indicated if the product needs to be treated after use; and(6) Other matters that shall be presented to operators and users for attention according to the product features.要消毒或者灭菌的应当说明 消毒或者灭菌的方法；（六）产品需要同其他医疗 器械一起安装或者联合使用 时，应当注明联合使用器械 的要求、使用方法、注意事 项；（七）在使用过程中，与其 他产品可能产生的相互干扰 及其

43、可能出现的危害；（A）产品使用中可能带来 的不良事件或者产品成分中 含有的可能引起副作用的成 分或者辅料；（九）医疗器械废弃处理时 应当注意的事项，产品使用 后需要处理的，应当注明相 应的处理方法；（十）根据产品特性，应当 提示操作者、使用者注意的 其他事项。第十二条重复使用的 医疗器械应当在说明书中明 确重复使用的处理过程，包 括清洁、消毒、包装及灭菌 的方法和重复使用的次数或 者其他限制。Article 12 The instruction of a reusable medical device shall specify the process of re-use, including

44、 cleaning, disinfection, packaging and sterilization methods and frequency of re-use or other restrictions.Article 13 The label of a medical device shall 第十三条 医疗器械标generally include:签一般应当包括以下内容：(1) Product name, model and specification;（一）产品名称、型号、规 格；(2) The name, domicile, contact information and a

45、ftersales service agencies of the registrant or the party undergoing recordation of the medical device, as well as the name, domicile and contact information of the agency if it is an imported medical device;(3) The name, domicile, contact information and aftersales service agencies of the registran

46、t or the party undergoing recordation of the medical device, as well as the name, domicile and contact information of the agency if it is an imported medical device;（二）注册人或者备案人的 名称、住所、联系方式，进 口医疗器械还应当载明代理 人的名称、住所及联系方 式；(4) The serial number of the medical device (三)医疗器械注册证编号 registration certificate

47、or the recordation certificate;或者备案凭证编号；(5) The name, domicile, production address and contact information of the production enterprise and the serial number of its production license or production recordation certificate, as well as the name, domicile and production address of the entrusted（四）生产企业的

48、名称、住 所、生产地址、联系方式及 生产许可证编号或者生产备 案凭证编号，委托生产的还 应当标注受托企业的名称、enterprise and the serial number of its production license or production recordation certificate if the medical device is entrusted for production;住所、生产地址、生产许可 证编号或者生产备案凭证编 号；(6) Production date and service life or expiration date;（五）生产日期，使用期限 或者失效日期；(6) Power connection conditions and input power;(6) Power connection conditions and input power;（六）电源连接条件、输入 功率；