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俄罗斯标准认证集团
JSC "Standard Group"

俄罗斯认证
经合
俄罗斯标准集团是俄罗斯最大的认证机构,在俄罗斯拥有自己的实验室和超过10年的工作经验。 标准集团拥有所有的认证许可。
TRCU 010/2011,TRCU 032/2013,TRCU 004/2011,TRCU020/2011,TR CU 005/2011,TRCU 016/2011,TR CU 017/2011,TR CU 021,/2011,TR CU 025/2011,TR EAEU 042/2017
俄罗斯医疗器械国家注册​证-Russian medical device registration certificate
    发布时间: 2016-08-01 19:25    

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俄罗斯医疗器械国家注册证-Russian medical device registration certificate

一、俄罗斯医疗器械注册证介绍:
俄罗斯医疗器械注册 主管机构是Roszdravnadzor (Россздравнадзор) ”(俄罗斯卫生监督局)(Roszdravnadzor)Federal service on surveillance in healthcare and social development of Russian Federation (Roszdravnadzor)
http://www.roszdravnadzor.ru/  负责俄罗斯联邦的医疗器械注册证的签发。

哪些产品需要医疗器械注册证
俄罗斯市场上的任何医疗产品包括:1类,2类,3类医疗器械在俄罗斯如果没有Roszdravnadzor医疗器械注册登记,是禁止的进口和销售的。医疗器械国家注册登记在俄罗斯有一套非常严格的测试和评估流程,以保证该产品的质量,效率和安全的。

医疗器械注册证书有效期:

医疗器械国家注册证,在2008年以前是5年有效期,从2008年以后注册登记证书的有效期限是无限期的。

二、俄罗斯医疗器械注册证过程阶段:

#

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

60days

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

60 working days*

1.5

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

60  working days*

1.6

Clinical tests 临床试验

30-45 days

俄罗斯医疗器械注册过程全程:10-12个月 。很多时间是需要文件的准备和反复的补充和修改。在我们收到全部资料和样品后大约8-10个月完成。如果中途遇到资料补充或测试不合格将会所有时间延迟。


、俄罗斯医疗器械注册认证过程和客控的付款方式--确保安全、放心

#

Stage阶段

服务内容

时间安排

1次预付款

30%

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

30%

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.

 

3次付款

30%

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*

4次付款

10%

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