罗斯医疗器械认证 , 俄罗斯牙科设备医疗器械注册认证, 俄罗斯手术器材医疗器械注册认证,外科设备俄罗斯GOST认证, 俄罗斯内窥镜认证,医用耗材俄罗斯医疗器械认证, 医用缝合线医疗器械认证, 俄罗斯外科手术服俄罗斯医疗器械认证, 成像器材俄罗斯医疗器械认证 ,色谱分析仪俄罗斯医疗器械认证, 诊室分析仪俄罗斯医疗器械认证, 透析俄罗斯医疗器械认证,医用抽气机哈萨克斯坦医疗器械认证, 俄罗斯输血系统哈萨克斯坦医疗器械认证, 俄罗斯X光机俄罗斯医疗器械认证,俄罗斯支架俄罗斯医疗器械认证,俄罗斯B超机俄罗斯医疗器械认证认证,俄罗斯一次性输液管医疗器械认证
# |
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。
三、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 |
第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。 |
第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.
|
第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* |
|
第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 |
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