境外医疗器械注册申请表（注册申请表范本模板下载）

产品名称

Product Name

中文：

Chinese

原文：

Original File

商品名

Trade Name

型号／规格

Model

产品类别/编码

Product Classification/code

注册形式

Registration Form

首次注册         □

Initial registration

重新注册          □

Renewal

产品标准   Product Standard

性能、结构及

组成

Main Structures & Performance

产品适用范围

Main Use

产品禁忌症

Contraindications

生产企业

Manufacturer

名称

Name

中文：

Chinese

国别

Country

原文：

Original Text

注册地址

Address

中文：

 Chinese

原文：

Original Text

生产地址

manufacture address

中文：

 Chinese：

原文：

Original Text

联系人

Contact Person

职位

Position

电话

Tel

传真

Fax

电子信箱

E-mail

代理人

Agent

名称

Name

地址

Address

邮编

Post

联系人

Contact person

职位

Position

电话

Tel

传真

Fax

电子信箱

E-mail

中国境内售后服务机构

After-Sales Service Representation

名称

Name

地址

Address

邮编

Post

联系人

Contact person

职位 Position

电话

Tel

传真

Fax

电子信箱

E-mail

申报者

Application Agent

名称

Name

地址

Address

邮编

Post

联系人

Contact person

职位

Position

电话

Tel.

传真

Fax

电子信箱

E-mail

首次注册     

Initial registration

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

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

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

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

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