Оther
services
Amendments
to the current registration certificate
Preparation of a set of documents for
new registrations
medical device
About us
20 years of experience of a team of experts in the market of medical products registration.
Provision of "full cycle" services - a service is considered to be provided after receiving a registration certificate, not after submitting a set of documents to Roszdravnadzor.
No outsource specialists involved. All the documentation is prepared by our own staff of specialized specialists.
The documents prepared by our company fully meet the requirements of acting legislation.
Services
The stages of preparing the documentation for
new medical device registration
1. analysis of customer's documentation and formation of registration dossier
2. organization of obtaining permission to import a medical device
3. organizing technical and toxicological studies
4. organization of translation and notarization of documents
5. compilation and writing of information on normative documentation
6. drawing up a table of the equivalence of medical device interchangeability
7. evaluation and analysis of the application of types of national standards
8. analysis, adjustment and reconciliation of operating documents
9. filing the registration dossier with Roszdravnadzor
10. control over compliance with the terms of Stage I of the examination
11. preparation, verification and approval of the Act, Protocol, Programme and Methodology for conducting clinical trials of a medical device
12. assistance in organizing clinical trials
13. Stage II of the expertise - control of compliance with the terms of its execution
... as well as a number of other measures required to obtain the registration certificate for the medical device and its transfer to the customer.
Why choose us
Industry news
Registration of medical devices is a state procedure aimed at allowing the release of quality and safe products to the Russian market. Part 4 of Article 38 of the Federal Law of 21.11.2011 No. 323-FZ "On the fundamentals of health protection of citizens in the Russian Federation" establishes that on the territory of the Russian Federation circulation of medical devices registered in accordance with the procedure established by the Government of the Russian Federation, the federal executive authority authorized by it is allowed.
The procedure for state registration was approved by Government Decree of the Russian Federation No. 1416 of 27 December 2012 "On approval of the rules for state registration of medical devices".
This service includes a wide range of changes in factual information contained in the current registration certificate for a medical device, for example:
1. changes in the manufacturer's information;
2. expanding the functionality of medical devices;
3. issuance of a duplicate registration certificate or replacement of the registration certificate.
Specialists of our company have the necessary knowledge and experience in preparing the registration dossier, with subsequent submission to the Federal Service for Supervision of Healthcare.
Credo LLC is part of a group of companies representing the interests of Russian and foreign manufacturers of medical devices.
Our company specialises in promptly providing a full range of services for the preparation of the registration dossier for a medical device and its submission to the Federal Service for Surveillance in Healthcare (Roszdravnadzor).
For more than twenty years, our company's experts have played the role of a strong link between state-of-the-art medical devices and the Russian medical market.
Experts of our company are also ready to render a number of services accompanying registration of medical devices, namely:
1. obtaining a duplicate of the registration certificate;
2. replacement of the registration certificate form;
3. certification and declaration;
4. technical and clinical tests;
5. toxicological tests;
6. electromagnetic compatibility testing of the medical device;
7. Testing of the medical device for the purpose of approving the measuring instruments;
Registration of medical devices within the framework of the Eurasian Economic Union is carried out in accordance with the Decision of the Council of the Eurasian Economic Commission dd. 12.02.2016 No. 46 "Rules for registration and examination of safety, quality and efficiency of medical devices".