进口医疗器械首次注册--递交 NMPA 资料清单
Documents Required for initial NMPA registration of imported medical devices
蓝色标记的资料由境外申请人提供
Documents with blue color are required to be provided by the applicant in overseas country
绿色标记的资料由中国代理人提供
Documents with green color are required to be provided by China Agent
黄色标记的资料需在境外公证
Documents with yellow color are required to be notarized in overseas country
Notes:
 以下资料清单为最终递交至 NMPA 的所有资料，包括了需由境外申请人，中国代理人和奥咨达准备的资料。
Documents below are required to be submitted to NMPA, including the ones prepared by the applicant, China Agent and Osmunda.
 每个阶段需提供的资料项目组会在邮件中说明，请在项目组的邮件通知和指导下进行签章和公证。
The project team will tell you the documents you need to provide in every stage, please sign documents and do notarizations upon the email notification and guidance of the
project team.
 资料的前期提供均为电子版本，需要原件纸质版本时项目组会及时邮件告知。
The documents without signature and notarization are needed in electronic version in advance. The project team will contact you when the original ones are needed.
 这里的“申请人”指以自己名义把产品推向市场并对产品负法律责任的境外企业。
“Applicant” herein refers to the overseas enterprise who distributes the products into the market in his own name and bears the final legal responsibility for the products.
 进口产品申报资料如无特别说明，原文资料均应由申请人签章，中文资料由代理人签章。原文资料“签章”是指：申请人的法定代表人或者负责人签名，或者签名并
加盖组织机构印章，并且应当提交由申请人所在地公证机构出具的公证件；中文资料“签章”是指：代理人盖公章，或者其法定代表人、负责人签名并加盖公章。
For the imported medical devices, if there are no special instructions, the original materials shall be “signed” by the applicant and the Chinese materials shall be “signed” by the
Agent. The signature and seal requirements of original materials refer to: ① signed by the legal representative or the person in charge of the applicant; or ② signed by the
legal representative or the person in charge of the applicant + sealed with the company chop of the applicant. The original materials shall be notarized by the notary organization
where the applicant is located. The signature and seal requirements of Chinese materials refer to: ① sealed with the company chop of the Agent; or ② signed by the legal
representative or the person in charge of the Agent + sealed with the company chop of the Agent.
#
1
2
文件名称
Documents
申请表
Application form
证明性文件
Approval documents
子文件名称
Subdocuments
01-1: 申请表
01-1: Application form
02-1: 境外申请人注册地或生产地址所
在国家（地区）医疗器械主管部门出具
的允许产品上市销售的证明文件（例如
CE 证书）
02-1: The evidential documents
certifying the product to be registered has
been approved by the competent
department in charge of medical devices
to enter the market in the country (or
region) where the registration place or
the manufacturing site of the registration
applicant is located (e.g. CE certificate)
02-2: 02-1 的翻译件
02-2: Chinese translation of 02-1
02-3: 企业资格证明文件（例如 ISO
13485 证书）
02-3: Certificate of legal production
qualification for the manufacturer (e.g.
ISO 13485 certificate)
02-4: 02-3 的翻译件
02-4: Chinese translation of 02-3
02-5: 代理人委托书
02-5: Certificate of commission given by
the applicant to China Agent
02-6: 02-5 的翻译件
02-6: Chinese translation of 02-5
02-7: 代理人承诺书
02-7: Letter of commitment of the agent
02-8: 代理人营业执照副本
02-8: Copy of Business license of the
agent
包括内容
Details
签章
Signature & Seal
Requirement
代理人签章
By China Agent
境外申请人签章
By the applicant
奥咨达协助填写
Osmunda assists to fill out.
需公证
To be notarized.
代理人签章
By China Agent
境外申请人签章
By the applicant
需公证
To be notarized.
代理人签章
By China Agent
境外申请人签章
By the applicant
代理人签章
By China Agent
代理人签章
By China Agent
代理人签章
By China Agent
备注
Remarks
需公证。奥咨达提供模板。
To be notarized.
Osmunda provides template.
奥咨达提供模板
Osmunda provides template.
奥咨达提供模板
Osmunda provides template.
#
3
4
5
文件名称
Documents
子文件名称
Subdocuments
医疗器械安全有效基
本要求清单
Essential requirements
checklist for the safety
and effectiveness of
medical devices
综述资料
Summarized data
03-1: 医疗器械安全有效基本要求清单
03-1: Essential requirements checklist
for the safety and effectiveness of
medical devices
03-2: 03-1 的翻译件
03-2: Chinese translation of 03-1
04-1: 综述资料
04-1: Summarized data
研究资料
Research data
04-2: 04-1 的翻译件
04-2: Chinese translation of 04-1
05-1: 研究资料
05-1: Research data
包括内容
Details
包括以下内容 including:
4.1 概述 Product overview;
4.2 产品描述 Product description;
4.3 型号规格 Models and specifications;
4.4 包装说明 Packaging description;
4.5 适用范围和禁忌症 Scope of application and contraindications;
4.6 参考的同类产品或前代产品的情况（如有）Comparison between
the device to be registered and predicate device which have been
approved at home and abroad or its predecessor (if any);
4.7 其他需说明的内容 Other contents needing to be explained.
包括 including:
5.1 产品性能研究
Product performance research data
5.2 生物相容性评价研究（提供与人体接触材料的生物相容性报告）
Biocompatibility evaluation data (provide biocompatibility test
report for skin-contacting materials)
5.3 生物安全性研究（如果产品含有同种异体材料、动物源性材料及
生物活性物质等具有生物安全风险的组分）
Biosafety research data (if the product contains component with
biological safety risk such as allogeneic material, animal origin material
and bio-activator)
5.4 灭菌/消毒工艺研究（提供灭菌/消毒验证报告）
Research data of sterilization/disinfection processes (provide
sterilization/disinfection verification reports)
5.5 产品有效期和包装研究（提供产品有效期和包装验证报告）
签章
Signature & Seal
Requirement
境外申请人签章
By the applicant
备注
Remarks
需公证。奥咨达提供模板。
To be notarized.
Osmunda provides template.
代理人签章
By China Agent
境外申请人签章
By the applicant
需公证
To be notarized.
代理人签章
By China Agent
境外申请人签章
By the applicant
需公证
To be notarized.
#
文件名称
Documents
子文件名称
Subdocuments
包括内容
Details
签章
Signature & Seal
Requirement
备注
Remarks
Research data of period of validity and packaging (provide lifetime
and packaging verification reports)
5.6 临床前动物试验
Preclinical animal testing
5.7 软件描述文档
Software description document
5.8 其他资料
Other data
6
7
生产制造信息
Manufacturing
information
临床评价资料
Clinical evaluation data
8
产品风险分析资料
Risk analysis data
9
产品技术要求
Product technical
05-2: 05-1 的翻译件
05-2: Chinese translation of 05-1
06-1: 生产制造信息
06-1: Manufacturing information
06-2: 06-1 的翻译件
06-2: Chinese translation of 06-1
07-1: 境外政府医疗器械主管部门批准
该产品上市时的临床评价资料
07-1: Clinical evaluation data when the
product was approved by the competent
department in charge of medical devices
in the country (or region) of origin.
07-2: 07-1 的翻译件
07-2: Chinese translation of 07-1
07-3: 临床评价报告（根据 NMPA 要求
编写）
07-3: Clinical evaluation report
(complying with NMPA regulations)
08-1: 产品风险分析资料
08-1: Risk analysis data
08-2: 08-1 的翻译件
08-2: Chinese translation of 08-1
09-1: 产品技术要求（中文版）
09-1: PTR (in Chinese)
包括 including:
6.1 生产过程信息描述 Description of production process;
6.2 生产场地 Manufacturing site(s)
代理人签章
By China Agent
境外申请人签章
By the applicant
需公证
To be notarized.
代理人签章
By China Agent
境外申请人签章
By the applicant
需公证
To be notarized.
代理人签章
By China Agent
境外申请人签章
By the applicant
需公证
To be notarized.
境外申请人签章
By the applicant
代理人签章
By China Agent
代理人签章
By China Agent
需公证
To be notarized.
奥咨达和客户共同起草中
#
文件名称
Documents
子文件名称
Subdocuments
包括内容
Details
签章
Signature & Seal
Requirement
requirements (PTR)
10
产品注册检验报告
Product testing report
11
产品说明书和最小销
售单元的标签样稿
Instructions for use &
label design drafts for
the minimum
marketing unit
12
符合性声明
09-2: 09-1 的翻译件
09-2: English translation of 09-1
09-3: 产品技术要求（中文，一式两份）
09-3: PTR (in Chinese, in duplicate)
09-4: 两份产品技术要求的一致性声明
09-4: Conformance statement of two
copies of PTRs
10-1: 注册检验报告
包括 including:
10-1: Testing report
安规性能检验报告 Safety and performance testing report
电磁兼容检验报告 EMC testing report
11-1: 产品原文说明书
11-1: The original instructions for use
11-2: 11-1 的翻译件
11-2: Chinese translation of 11-1
11-3: 中文说明书（符合 NMPA 法规要
求）
11-3: Instructions for use in Chinese
(complying with NMPA regulations)
11-4: 最小销售单元的标签样稿
11-4: The original label for the minimum
marketing unit
11-5: 11-4 的翻译件
11-5: Chinese translation of 11-4
11-6: 中文最小销售单元的标签样稿
（符合 NMPA 法规要求）
11-6: Label design draft for the
minimum marketing unit in Chinese
(complying with NMPA regulations)
12-1: 符合性声明
境外申请人签章
By the applicant
代理人签章
By China Agent
代理人签章
By China Agent
备注
Remarks
文版。
Chinese version is jointly
drafted by Osmunda and
client
需公证。
To be notarized.
奥咨达提供模板
Osmunda provides template.
检测机构出具
Issued by testing
institute
境外申请人签章
By the applicant
代理人签章
By China Agent
境外申请人签章
By the applicant
需公证
To be notarized.
境外申请人签章
By the applicant
需公证
To be notarized.
代理人签章
By China Agent
境外申请人签章
By the applicant
需公证
To be notarized.
境外申请人签章
需公证。奥咨达提供模板。
需公证
To be notarized.
#
文件名称
Documents
Declaration of
conformity
子文件名称
Subdocuments
12-1: Declaration of conformity
12-2: 12-1 的翻译件
12-2: Chinese translation of 12-1
12-3: 申请人所交材料真实性的自我保
证声明
12-3: Declaration of authenticity of the
applicant for the submitted materials
12-4: 12-3 的翻译件
12-4: Chinese translation of 12-3
12-5: 代理人所交材料真实性的自我保
证声明
12-5: Declaration of authenticity of the
agent for the submitted materials
包括内容
Details
签章
Signature & Seal
Requirement
By the applicant
代理人签章
By China Agent
境外申请人签章
By the applicant
代理人签章
By China Agent
代理人签章
By China Agent
备注
Remarks
To be notarized.
Osmunda provides template.
奥咨达提供模板
Osmunda provides template.
需公证。奥咨达提供模板。
To be notarized.
Osmunda provides template.
奥咨达提供模板
Osmunda provides template.
奥咨达提供模板
Osmunda provides template.