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Registration certificate/俄罗斯医疗器械注册证

 2、申请俄罗斯证书类型:Registration certificate/俄罗斯医疗器械注册证

 

二、付款细节和条件。

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注册过程-注册证书结果

Term

大约时间安排

1.1

Technical trials  (1)技术试验

45 days

1.2

Toxicological trials (2)毒理学试验

1.3

Normative document development (3)规范性文件准备

1.4

Maintenance of process (working with Federal Service) (4)联盟政府工作-过程中的维护

50 working days*

1.5

Providing of quality, safety and effectiveness expertise **  (5)提供质量、安全和专业知识

30 working days*

1.6

Clinical tests 临床试验

30-45 days

全程:10-12个月 

Explanatory notes/解释和说明 :

1.       项目根据联邦政府注册服务的规范性文件条款要求,安排进行临床试验不包括在规范性文件里面,通常需要2个月时间。

2.       俄罗斯医疗器械注册证书的签发期限为自从乙方收到预付款和俄罗斯实验室从接收到样品并确认所有文件符合要求之日起开始10-12个月完成,但是它可以在俄罗斯联邦政府机构工作延迟的情况下也延迟。

3.       注册过程最好有当地公司(当地的代理公司)-只列出公司名称在技术文档中,如果没有当地代表,需要授权书上指定我们俄罗斯公司办公室即可。(如果需要我们会准备)

4.       以上费用不包括:俄文资料的翻译费用,甲方提供文件资料和证书的合法化公证费用、样品邮寄费用和产品重复测试份费用。

5.       请找到附本合同第四条所列的文件清单,请不要未经俄罗斯办事处批准,开始文件公证。

6.       请不要不加解释直接邮寄样本到俄罗斯办事处。

7.    测试样品数量-3件。

三、Payment details付款方式

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Stage阶段

服务内容

时间安排

1次预付款

Application stage 申请阶段一

Statement (application) for registration. 申请注册程序的声明

Documents translation.文件翻译

Customs clearance of sample (if required).如果需要,样品通关

Normative document development.规范性文件的准备

As a result – statement, normative document, samples and documents are in Russian office.其结果-声明,规范性文件,样品和文件都在俄罗斯办公室

Depends on customs and customer activity.依赖于海关和客户的活动。

The term of statement and normative document development – 20 days.说明和规范性文件的准备-20天。

2次付款

Registration dossier preparation + expertise注册卷宗准备+专业知识

Technical and toxicological testing.技术和毒理试验

As a result – tests reports and entering number of registration dossier.其结果-测试报告和进入注册卷宗

The term of tests providing - 45 days.

 

Clinical test 临床试验

Clinical testing.临床试验

As a result – test reports from hospital or conclusion from ethic department of Ministry of Health.其结果-来自医院测试报告或卫生部的结论

30-45 days**

Expertise (second stage)专业知识(第二阶段)

As a result – expert conclusion.其结果-鉴定结论

 

20 days*

3次付款

Registration certificate is issued 签发注册证书

Before this stage Russian office sends a scan copy of registration certificate.这个阶段俄罗斯发出注册证书的扫描件副本。

As a result – an original of registration certificate. Delivery of original by express mail is not included.其结果是-注册证书原件,不包括原件的送货快递费用

7 days

 

 

四、List of documents 要求提供的文件清单

 

 

Name

Number of copies

Description

1

Power of attorney 授权书

1

International legalization in country of origin (apostil or council legalization).需要原产国国际合法化公证

Power of attorney must be done for attached sample (ask Russian office to do it). Must be translated into Russian**.授权委托书附有样本(请俄罗斯办公室来完成)。必须翻译成俄文合法化公证。

2

Business registration of manufacturer in country of origin制造商营业执照和组织代码证

1

International legalization in country of origin (apostil or council legalization). Must be translated into Russian.

翻译成俄文并合法化公证

3

ISO 9001 and

ISO 13485 

 

1

International legalization in country of origin (apostil or council legalization). Must be translated into Russian.翻译成俄文并合法化公证。

4

Certificate MDD 93/42/ЕЕС (CE certificate)

CE证书

1

International legalization in country of origin (apostil or council legalization). Must be translated into Russian.

翻译成俄文并合法化公证

5

Declaration of conformity  (if risk class of device is 1 or 2a)

(or Certificate93/42/ЕЕС for In-Vitro products)  CE声明证书

1

International legalization in country of origin (apostil or council legalization), if required (ask Russian office to check). Must be translated into Russian.

翻译成俄文并合法化公证,(如果需要帮助问俄罗斯办公室检查)

6

Technical file (that was used for CE certification) CE技术文件

1

Must be translated into Russian. 翻译成俄文。International legalization in country of origin (apostil or council legalization) if required – second stage of documents legalization. 合法化公证如果需要在第2阶段准备

7

User manual (with all accessorizes and reference numbers description) 用户使用手册 (包括所有配件和参考型号的说明)

1

Must be translated into Russian.翻译成俄文 International legalization in country of origin (apostil or council legalization) if required – second stage of documents legalization.合法化公证如果需要在第2阶段准备

8

Brochure (with all accessorizes and reference numbers) with color photo of product (a4 size)宣传册,(包括所有的配件和参考型号)和产品彩色照片(A4尺寸)

1

Must be translated into Russian.必须翻译成俄文。

9

FDA registration certificate  FDA注册证书

1

Legalization in country of origin (apostille) – for USA companies. Must be translated into Russian.  美国制造商必须翻译成俄文,合法化公证

10

Free sale certificate 自由销售证书

1

Legalization in country of origin (apostille) – for USA companies. Must be translated into Russian.美国制造商-必须翻译成俄文,合法化公证

11

License for the medical device manufacturing 医疗器械生产许可证

1

Legalization in country of origin – for Chinese or Taiwan companies. Must be translated into Russian.中国和台湾制造商必须翻译成俄文,合法化公证

12

Product registration in China (or Taiwan) 中国产品注册

1

For Chinese or Taiwan companies, if required.

中国和台湾制造商-医疗器械注册证

13

Registration certificate (medical device registration) in country of origin  医疗器械注册证

1

Legalization in country of origin – for CIS companies. Must be translated into Russian.

必须翻译成俄文,俄罗斯驻中国大使馆合法化公证

14

Technical documentation (technical file or normative document) in country of origin.技术文件(技术文件或规范性文件)在原产国

1

Legalization in country of origin – for CIS companies. Must be translated into Russian.必须翻译成俄文,俄罗斯驻中国大使馆合法化公证