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KombiMEd - Medical Device Product Registration Services
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.
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.
- 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