• Ostenhellweg 50-52 | 44135 Dortmund | NRW
  • info@kombi-med.com

Product Registration

Approval of medical devices in the Commonwealth of Independent States

Since the approval of medical devices in the Commonwealth of Independent States (CIS) is based on a separate product test, approval procedures for European companies are often a challenge. European product certificates (CE and FDA) are not recognised and are partially ignored. The approval procedure consists of several steps and passes through various bureaucratic stages, which must be strictly adhered to.


Your advantages with KombiMED

KombiMED takes care of all these steps up to the state approval of your medical devices and their official registration. On site, this process is carried out by an experienced legal entity, as the processing of formalities or transactions takes place largely on a personal level. In this way, as a European manufacturer of medical devices, you can overcome bureaucratic hurdles and language barriers in the best possible way.

What we do in this area:

  • Determination of the classification of your medical devices
  • Market research for possible sales
  • Identification of the necessary product tests
  • Coordination with the authorities
  • Preparation of the necessary documents
  • Translation coordination


Acceptance and handling of all bureaucratic steps during all project phases


Submission of the required applications up to and including product approval


Coordination of product testing and laboratory tests for product approval

Can we help you?

Do you have any questions or would you like to send us a message? We look forward to seeing you!


We serve customers in Eastern Europe and the Commonwealth of Independent States (CIS). These include doctors' surgeries, medical facilities, rehabilitation centres, medical training facilities and veterinary practices as well as specialist medical trade.

Social contact


Company address

Ostenhellweg 50-52
44135 Dortmund

тел:      +49 231 / 330 1987 - 0
E-Mail: info@kombi-med.com

Copyright © 2023 KombiMED GmbH.