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For Manufacturers

  • Do you manufacture medical devices and equipment?
  • Does your product have the potential and is equal or better than the products of well-known world manufacturers?
  • Would you like to register your products in the Russian Federation?
  • Are you looking for a distributor that is able to ensure your product’s presence in Russia, the CIS countries, Europe and Latin America?
We are ready to start negotiations immediately!
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Nano Medical Group will take care of everything: registration, certification, marketing and, of course, sales for you to focus on the main task - production!
Register a product

Nano Medical Group by numbers

  • More than
    10
    years on the market
  • More than
    20
    contracts with global manufacturers
  • More than
    10
    products for registration in the Russian Federation
  • Annual participants of the
    10
    largest Russian exhibitions of medical equipment and devices

Package of offers for manufacturers

Own department for the registration of medical devices
Free support for the registration of your products in Russia
We do not request a CE certificate to start registration in the Russian Federation
Product registration and launch on the market takes 1 to 2 years
Own developed sub-distribution network
A unique, active sales system that can introduce any product to the market quickly
Do you want to register your medical device on the Russian market?
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Procedure for the registration of medical devices in Russia

1
Review of STED (Summary Technical Documentation) file
The most difficult stage takes from 2 to 6 months, depending on the STED file completeness. A correct STED file comprises 80% of your success when obtaining a certificate of registration (COR).
2
Technical and toxicological tests
Testing of a medical device for compliance with the Russian standards.
3
Preparation and submission of the registration dossier to Roszdravnadzor (the Federal Service for Surveillance in Health Care)
Combining the previously prepared STED file and the results of technical and toxicological tests.
4
Finalisation and submission of the STED file to the 2nd stage
Submission of additional information on the request issued by Roszdravnadzor and the elimination of non-compliances revealed.
5
Preparing and conducting clinical studies
Submission of information on the safety of the device for clinical use in humans.
6
Finalisation and submission of the STED file to the final stage
Correction and submission of additional information on the clinical safety of the medical device, which proves the possibility of issuing the certificate of registration.
7
Issue of the certificate of registration.

Do you want to obtain the analytics for your product?

IPOM PP
We investigate the Russian market for the possible promotion of your product.
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