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Order of State Food and Drug Administration
(No.10)
The Provisions on the Administration of Manuals, Labels and Package Marks of Medical Devices, which were deliberated and adopted at the executive meeting of State Food and Drug Administration on June 18, 2004, are hereby promulgated and shall come into force as of the date of promulgation.
Commissioner: Zheng Xiaoyu
July 8, 2004
Provisions on the Administration of Manuals, Labels and Package Marks of Medical Devices
| | 国家食品药品监督管理局令
（第10号）
《医疗器械说明书、标签和包装标识管理规定》于2004年6月18日经国家食品药品监督管理局局务会审议通过，现予公布。本规定自公布之日起施行。
局长 郑筱萸
二00四年七月八日
医疗器械说明书、标签和包装标识管理规定
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Article 1 These Provisions are enacted according tothe Regulation on the Supervision and Administration of Medical Devices for the purpose of regulating the manuals, labels and package marks 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、标签和包装标识，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。
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Article 2 Medical devices sold or used within the territory of the People's Republic of China shall be accompanied by manuals, labels and package marks according to these Provisions. For the easy-to-use products, one or two items of manuals, labels and package marks may not be furnished if State Food and Drug Administration (hereinafter referred to as the SFDA) has so provided.
| | 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、标签和包装标识。简单易用的产品，按照国家食品药品监督管理局的规定，可以省略说明书、标签和包装标识三项中的某一项或者某两项的，依照其规定。
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Article 3 Users of medical devices shall use the medical devices according to the manuals of medical devices.
| | 第三条 医疗器械的使用者应当按照医疗器械说明书使用医疗器械。
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Article 4 The “manuals of medical devices” refers to those technical documents that are made by production enterprises, are provided for users together with products, can cover the basic information about the safety and validity of products, and can be used for guiding the correct installation, debugging, operation, use, repair and maintenance of products.
The “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.
The “package marks of medical devices” refers to the written descriptions, graphics and symbols that are indicated on packages and are used for reflecting main technical features of medical devices.
| | 第四条 医疗器械说明书是指由生产企业制作并随产品提供给用户的，能够涵盖该产品安全有效基本信息并用以指导正确安装、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包装上附有的，用于识别产品特征的文字说明及图形、符号。
医疗器械包装标识是指在包装上标有的反映医疗器械主要技术特征的文字说明及图形、符号。
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Article 5 The contents in the manuals, labels and package marks of medical devices shall be true, complete, accurate and scientific, and consistent with the product features.
The contents in the labels and package marks of medical devices shall be consistent with those in the manuals.
| | 第五条 医疗器械说明书、标签和包装标识的内容应当真实、完整、准确、科学，并与产品特性相一致。
医疗器械标签、包装标识的内容应当与说明书有关内容相符合。
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Article 6 The language used in the manuals, labels and package marks of medical devices shall be Chinese, and may be accompanied by any other language. The use of Chinese shall comply with the language and character criteria as commonly used in China.
The characters, symbols, graphics, tables, figures, photos and pictures, etc. used in the manuals, labels and package marks of medical devices shall be accurate, clear and normalized.
| | 第六条 医疗器械说明书、标签和包装标识文字内容必须使用中文，可以附加其他文种。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、标签和包装标识的文字、符号、图形、表格、数字、照片、图片等应当准确、清晰、规范。
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Article 7 The manuals of medical devices shall comply with the relevant requirements in national criteria or industrial criteria, and shall generally contain:
| | 第七条 医疗器械说明书应当符合国家标准或者行业标准有关要求，一般应当包括以下内容：
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1. Product name, model and specifications;
| | （一）产品名称、型号、规格；
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2. Production enterprise's name, registered address, production address, contact information and after-sales service agency;
| | （二）生产企业名称、注册地址、生产地址、联系方式及售后服务单位；
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3. Serial number of the Permit for the Medical Device Production Enterprise (excluding the first category of medical devices), and the serial number of the medical device registration certificate;
| | （三）《医疗器械生产企业许可证》编号（第一类医疗器械除外）、医疗器械注册证书编号；
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4. Serial number of product standards;
| | （四）产品标准编号；
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5. Performances, main structure and applicable scope of products;
| | （五）产品的性能、主要结构、适用范围；
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6. Contraindications, matters for attention, and other warnings or tips;
| | （六）禁忌症、注意事项以及其他需要警示或者提示的内容；
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7. Interpretations about graphics, symbols and abbreviations, etc. used in the labels of medical devices;
| | （七）医疗器械标签所用的图形、符号、缩写等内容的解释；
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8. Instructions or drawings for installation and use;
| | （八）安装和使用说明或者图示；
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9. Product maintenance methods, special storage conditions and methods;
| | （九）产品维护和保养方法，特殊储存条件、方法；
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10. The validity term shall be indicated for the products with a time limit for use; and
| | （十）限期使用的产品，应当标明有效期限；
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11. Other contents that shall be contained in the manuals as prescribed in the product criteria.
| | （十一）产品标准中规定的应当在说明书中标明的其他内容。
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Article 8 The labels or package marks of medical devices shall generally contain:
| | 第八条 医疗器械标签、包装标识一般应当包括以下内容：
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1. Product name, model and specifications;
| | （一）产品名称、型号、规格；
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2. Production enterprise's name, registered address, production address and contact information;
| | （二）生产企业名称、注册地址、生产地址、联系方式；
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3. Serial number of the medical device registration certificate;
．．．．．． | | （三）医疗器械注册证书编号；
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