Things we can do for you
OUR SERVICES
Arrangement of import licenses
Please remember that an import license doesn’t replace a State Customs Declaration (SCD). SCD is mandatory because laboratories have no right to test samples without this document.
Registration of medical products and devices in Russia
Any medical product or device which is being manufactured in Russia or abroad is subject to mandatory registration within the territory of the Russian Federation.
Registration of medical products and devices within Eurasian Union
Please visit the official website of the Eurasian Union for more detailed information on expert evaluation, registration and provisions.
Development of documentation for medical products and devices
Development of documentation for medical items is the central part of our work and the main process of preparation for registration of medical products and devices (MDs).
Documentation audit
Discrepancies in the documentation are not crucial. On the contrary, unavailability of some documents, for example, of a trademark registration certificate will automatically entail lack of approval. It is rather difficult to resume the process in this case. That’s why all documentation needs to be audited before the whole file is forwarded to the registration body.
Amendments
Altering the registration documents package including the marketing authorisation. We will assist you making prompt amendments to a marketing authorization / Roszdravnadzor’s (Federal Service for Supervision in Healthcare) docket.