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受理号：______
中华人民共和国 境外医疗器械注册申请表 APPLICATION FORM FOR REGISTRATION OF OVERSEA MEDICAL DEVICE
产品名称： ______________ Product Name 型号、规格：____________ Model 生产企业：______________ Manufacturer 代理人： ________________ Agent
国家食品药品监督管理局 STATE FOOD AND DRUG ADMINISTRATION |
填 表 说 明
1．依据《医疗器械注册管理办法》和《境内第三类、境外医疗器械注册申报资料受理标准》、及相关文件的规定制定本表。
2．本申请表从中国医疗器械信息网（WWW.CMDI.GOV.CN）免费下载。要求填写的栏目内容应打印完整、清楚、不得空白，无相关内容处应填写“∕”或“无”；因申请表格式所限而无法填写完整时，请另附附件；申报时应一并提交含有申请表内容的电子文档（附件内容应为Word或E×cel形式）。
3．申报产品名称、型号、规格应与所提交的产品上市批件、产品标准、检测报告、产品使用说明书等申报资料实质性内容相对应。
4．注册形式：填写“首次注册”或“重新注册”。
5．产品类别及编码应依据中国医疗器械分类规则及医疗器械分类目录填写。
6．生产企业是指以自己的名义把产品推向市场，并对该产品的安全性、有效性负最终责任的单位；生产企业注册地址是指生产企业营业执照或注册登记证书上标注的地址。生产地址是指产品实际加工制造的地址。
7．产品标准：申请注册的产品如声明执行中国国家标准或行业标准，直接填写标准名称及编号；如执行注册产品标准，则填写注册产品标准名称。
8．申报者是指受境外生产企业委托，为其办理产品注册事务的单位（生产企业直接申请注册，申报者栏目填“/”）。
9．代理人是指境外生产企业指定的在中国境内能够承担相应的法律责任的机构。
10.原文应与境外上市批件所用文字一致；如无境外上市批件的，则应与生产企业所在国文字一致。
11．如申报材料中有需要加以说明的问题，请在本表“其他需要说明的问题”栏中说明
12．请在“注册申请应附资料及顺序”栏对应项目右侧方框内划“√”。如根据有关规定，某项材料不需提交，请在该项目右侧的方框内划“#”，并在本表“其他需要说明的问题”栏中写明理由。
注：填表前，请详细阅读填表说明 Please Read the Direction Before Filling in
产品名称 Product Name |
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商品名 Trade Name |
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型号／规格 Model |
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产品类别/编码 Product Classification/code |
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注册形式 Registration Form |
首次注册 □ Initial registration
重新注册 □ Renewal | |||||
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产品标准 Product Standard |
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性能、结构及 组成 Main Structures & Performance
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产品适用范围 Main Use |
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产品禁忌症 Contraindications |
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生产企业 Manufacturer |
名称 Name |
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国别 Country |
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注册地址 Address |
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生产地址 manufacture address |
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代理人 Agent |
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中国境内售后服务机构 After-Sales Service Representation |
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申报者 Application Agent |
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注 册 申 请 应 附 资 料 及 顺 序
List of Documents Attached
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首次注册 Initial registration | |
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1. 境外医疗器械注册申请表 Application form for registration of import medical device
2. 医疗器械生产企业资格证明 Legal Qualification certification for medical device manufacturing enterprise
3. 申报者的营业执照副本和生产企业授予的代理注册的委托书 A Copy of applicant’s business license and proxy for registration entrusted by the Manufacturing enterprise
4. 境外政府医疗器械主管部门批准或认可的该产品作为医疗器械进入该国（地区）市场的证明文件 Documents proving that the product can enter a certain country (or region) as medical Device approved or accepted by the medical device competent departments of overseas governments 5. 适用的产品标准（及说明） Applicable product standard and instructions 6. 医疗器械说明书 Specification for medical device
7. 医疗器械检测机构出具的产品注册检测报告（适用于第二类、第三类医疗器械） Test report on product registration given by medical device inspection institutions (applicable to Class II and Class III medical device) 8. 医疗器械临床试验资料 Medical device clinical trials report
9. 生产企业出具的产品质量保证书 Product Quality Guarantee issued by the manufacturer certifying that the quality of the product to be registered for sale in China is exactly the same as that of the product marketed in the country (region) of origin 10．生产企业在中国指定代理人的委托书、代理人的承诺书及营业执照或者机构登记证明 Proxy of assigned agent of the manufacturer enterprise in china, written Commitment of the agent and business license or registration certificate of the agent
11．在中国指定售后服务机构的委托书、被委托机构的承诺书及资格证明文件 Letter of Authorization for designated after-sales service agency in China and Letter of Promisa and business license of the authorized agency 12.所提交材料真实性的自我保证声明 Self-declaration by the enterprise to guarantee the truthfulness of the documentation submitted |
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重新注册 Renewal | |
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1． 境外医疗器械注册申请表 Application form for registration of import medical device
2． 医疗器械生产企业资格证明 Legal Qualification certification for medical device manufacturing enterprise
3． 原医疗器械注册证书 Previous registration certificate
4． 申报者的营业执照副本和生产企业授予的代理注册的委托书 A Copy of applicant’s business license and proxy for registration entrusted by the Manufacturing enterprise
5． 境外政府医疗器械主管部门批准或者认可的该产品作为医疗器械进入该国市场（地区）的证明文件 Documents proving that the product can enter a certain country (or region) as medical Device approved or accepted by the medical device competent departments of overseas governments 6． 适用的产品标准及说明 Applicable product standard and instructions
7． 医疗器械说明书 Product instructions for use
8． 医疗器械质量检测机构出具的产品注册检测报告（适用于第二类、第三类） Test report on product registration given by medical device inspection institutions(applicable to Class II and Class III medical device) 9． 产品质量跟踪报告 Product quality tracking report
10．生产企业出具的产品质量保证书 Product Quality Guarantee issued by the manufacturer certifying that the quality of the product to be registered for sale in China is exactly the same as that of the product marketed in the country (region) of origin 11．生产企业在中国指定代理人的委托书、代理人的承诺书及营业执照或者机构登记证明 Proxy of assigned agent of the manufacturer enterprise in china, written Commitment of the agent and business license or registration certificate of the agent
12． 在中国指定售后服务机构的委托书、被委托机构的承诺书及营业执照 Letter of Authorization for designated after-sales service agency in China and Letter of Promises and business license of the authorized agency 13. 提交材料真实性的自我保证声明 Self-declaration by the enterprise to guarantee the truthfulness of the documentation submitted |
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未获得境外上市许可的一类医疗器械首次注册 Requirements for the Fist Time Registration Submission of Class I Overseas Medical Devices which have not been Granted Overseas Medical Device Marketing Approval | ||
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1． 境外医疗器械注册申请表 Application form for registration of import medical device
2． 生产企业资格证明文件 Legal Qualification certification for medical device manufacturing enterprise
3． 申报者的营业执照副本和生产企业授予的代理注册的委托书 A Copy of applicant’s business license and proxy for registration entrusted by the Manufacturing enterprise
4． 适用的产品标准及说明 Applicable product standard and instructions
5． 产品全性能检测报告 Test report on all specifications of the product
6． 生产产品的现有资源条件及质量管理能力（含检测手段）的说明 Remarks on the present resource conditions of the product and the ability in quality Control (including inspection means) of the manufacturing enterprise
7． 医疗器械说明书（可以不签章） Product instructions for use.(may not be signed and stamped)
8．生产企业在中国指定代理人的委托书、代理人的承诺书及营业执照或者机构登记证明 Proxy of assigned agent of the manufacturer enterprise in china, written Commitment of the agent and business license or registration certificate of the agent
9．在中国指定售后服务机构的委托书、被委托机构的承诺书及营业执照 Letter of Authorization for designated after-sales service agency in China and Letter of Promises and business license of the authorized agency
10．提交材料真实性的自我保证声明 Self-declaration by the enterprise to guarantee the truthfulness of the documentation submitted
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未获得境外上市许可的第二类、第三类医疗器械首次注册 Requirements for the Fist Time Registration Submission of Class II and Class III Overseas Medical Devices which have not been Granted Overseas Medical Device Marketing Approval | ||
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1． 医疗器械注册申请表 Application form for registration of import medical device
2． 生产企业资格证明文件 Legal Qualification certification for medical device manufacturing enterprise
3． 申报者的营业执照副本和生产企业授予的代理注册的委托书 A Copy of applicant’s business license and proxy for registration entrusted by the Manufacturing enterprise
4． 产品技术报告 Report on product technology
5． 安全风险分析报告 Analysis report on safety profile
6． 适用的产品标准及说明 Applicable product standard and instructions 7． 产品性能自测报告 Self-test report on product specification 8． 医疗器械检测机构出具的产品注册检测报告 Test report on product registration given by medical device inspection institutions 9． 医疗器械临床试验资料 Medical device clinical trials report
10．医疗器械说明书（应当由生产企业或其在中国的代表处签章） Product instructions for use
11．产品生产质量体系考核（认证）有效证明文件 Valid testimonial documents for e×amination of the product production quality system (certification)
12．生产企业在中国指定代理人的委托书、代理人的承诺书及营业执照或者机构登记证明 Proxy of assigned agent of the manufacturer enterprise in china, written Commitment of the agent and business license or registration certificate of the agent
13．在中国指定售后服务机构的委托书、被委托机构的承诺书及营业执照 Letter of Authorization for designated after-sales service agency in China and Letter of Promises and business license of the authorized agency
14． 提交料真实性的自我保证声明 Self-declaration by the enterprise to guarantee the truthfulness of the documentation submitted |
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其 他 需 要 说 明 的 问 题 Other explanations |
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生产企业/代理人（签章） 填表人（签字）
Manufacturer/Agent (sign and Seal) Signature of the Filling Person
日期 日期 Date Date |
