Group of companies «AiLFARMA»

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Registration of medical devices is a special procedure that is mandatory for all manufacturers and authorized representatives (distributors). Its main goal is to provide residents of the Russian Federation of the Customs and the European Union with high-quality and safe medical products

Service Description

Work process:

1. Analysis of the provided documentation for medical devices
2. Issuance of an import notification (for foreign medical devices)
3. Development of the necessary documentation for registration
4. Technical testing, toxicological testing, clinical testing
5. Submission of the registration dossier
6. Examination of submitted documents
7. If there are comments, their immediate elimination.
8. Obtaining a registration certificate

Deadlines for registration of medical devices:
On serious registration, the significance of the risk class for public health, the required amount of research and the use of the registration scheme (national procedure or registration procedure within the EAEU).
If you need registration of a medical product, we are ready to provide qualified assistance in this direction. The opportunity to save time is provided by the fact that our specialists carry out some stages of registration of medical products in parallel mode. This increases our competitiveness and, in turn, other companies that provide similar services.

The process of registration of medical-specific products takes the following terms:
1st class- from six months;
2a class and 2b class - from 10 months;
3rd class- about 1 year.

Group of companies «AiLFARMA»

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