1、文件准备
Preparation of documents(2 months)
2、样品进口
Import of product samples(2 months)
3、技术/毒理检测
Technical (and to xicology if necessary)trials (2-5 months）
4、临床试验
Clinical trials (2-3 months)
5、1st专家意见
1st expertise of the documents by FSSH(2months)
6、根据FSSH要求准备补充文档或补充试验
Preparation of additional documents or passing through additional trials according to the requirements of FSSH(2 months)
7、2nd 专家意见
2nd expertise of the documents by FSSH (if applicable)(2 months)
8、获取注册证
Registration Certificate
需要准备的文件：
1.The registration of company
(Extract from the register of legal entities)。
公司注册
2.Business license of the company。
营业执照
3.Power of Attorney from the Manufacturer to an authorized representative in Russia
授权信（当地授权代表 ）
4.CE certificate or CE Declaration
(Approval EC Directive 93/42/EEC or EC Directive 98/79/EEC for in-vitro devices)
CE证书/DOC非强制
5.CE certificate or CE Declaration
(Approval MDR(EU)2017/745 for medical device or IVDR(EU)2017/746) for in-vitro devices)
CE证书/DOC非强制
6.ISO 13485 (and lSO 9001 if possible)。
ISO13485体系证书
7.Instruction for use/Operator manual
说明书/操作手册
8.Service manual (if applicable)。
维修手册(如适用)
9.Declarations of Material。
材料声明
10.Essential Principles Conformity Checklist (List of Standards applied)。
适用标准清单
11.Risk management report。
风险管理报告
12.MSDS and Data Sheet
化学品安全数据说明书
13.Toxicology reports
(if the product or accessories contact with patient the manufacturer should provide)
毒理检测报告
14.Method of sterilization report
(in case medical product is sterile)
灭菌报告的方法(如果医疗产品是无菌的)
15.Validation of sterilization report
(in case medical product is sterile)
无菌验证报告
16.Analysis of specificity verification
(if applicable)
特异.性分析报告
17.Reproducibility evaluation report
(if applicable)
重现性评价报告
18.Certificate of Analysis test report
产品COA
19.Software test report (if applicable)
软件验证报告
20.EMS test report (if applicable)
EMC检测报告
21.Diagnostic specificity performance (if applicable)
诊断特异性性能
22.Diagnostic sensitivity performance (if applicable)
诊断灵敏度性能
23.Stability test report (if applicable)
稳定性报告
24.Performance evaluation test report
性能评价报告
25.Clinical report from the foreign county (anycountry except Russia)
临床报告(境外)
26.Study of matrix effect (if applicable)
矩阵效应研究
27.Potential interferences study (if applicable)
潜在干扰实验研究
28.Biological safety declaration
生物安全声明
29.Inter lot repeatability study (if applicable)
批间重复性研究
30.Inter lot reproducibility study (if applicable)
批间重现性研究
31.Effect of temperature variations associated to transport conditions on test kit (if applicable)
与运输条件相关的温度变化对检测试剂盒的影响
32.Picture of the visual appearance of the medical product with all accessories (min.size 18cm x 24cm)
产品及附件的外观图片
33.Product labels
产品标签
所有文档：
必须使用俄语，由公证人担保，并附有签章（由CCPlT）