| Order 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 Medical 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 30, 2014 | | 2014年7月30日 |
| Provisions on the Administration of Instructions and Labels of Medical Devices | | 医疗器械说明书和标签管理规定 |
| Article 1 This Regulation is developed for purposes of regulating the instructions and labels of medical devices and ensuring the safety in the use of medical devices. | | 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安全，根据《医疗器械监督管理条例》，制定本规定。 |
| Article 2 The medical devices sold or used within the territory of the People's Republic of China shall be accompanied by instructions and labels in accordance with these Provisions. | | 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。 |
| Article 3 The term “instructions 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 products and be used for guiding the correct installation, debugging, operation, use, repair and maintenance of products. | | 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，涵盖该产品安全有效的基本信息，用以指导正确安装、调试、操作、使用、维护、保养的技术文件。 |
| 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 product features and indicating the safety warnings. | | 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安全警示等信息的文字说明及图形、符号。 |
| Article 4 The contents in the instructions and labels of medical devices shall be true, complete, accurate and scientific, and consistent with the product features. | | 第四条 医疗器械说明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 contents 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。 |
| Article 5 For expressions on the names of diseases, professional 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 measurement shall meet the relevant national standards. | | 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，应当采用国家统一发布或者规范的专用词汇，度量衡单位应当符合国家相关标准的规定。 |
| Article 6 The symbol or 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. | | 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。 |
| Article 7 Each minimum sales unit of a medical device shall be attached with an instruction. | | 第七条 医疗器械最小销售单元应当附有说明书。 |
| The user of a medical device shall use the medical device in accordance with the instruction. | | 医疗器械的使用者应当按照说明书使用医疗器械。 |
| Article 8 A medical device 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 certificates. | | 第八条 医疗器械的产品名称应当使用通用名称，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则。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。 |
| The product names shall be clearly indicated at the eye-catching places of the instructions and labels. | | 产品名称应当清晰地标明在说明书和标签的显著位置。 |
| Article 9 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 Chinese language. The instructions and labels of medical devices may be accompanied by any other language, but the Chinese version shall prevail. | | 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。 |
| The characters, symbols, tables, figures, graphics, etc. used in the instructions and labels of medical devices shall be accurate, clear and standard. | | 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。 |
| Article 10 The instruction of a medical device shall generally include: | | 第十条 医疗器械说明书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 after-sales 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;
．．．．．． | | （二）注册人或者备案人的名称、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；
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