A team that understands medical device registration from inside the market
Gentimed Consult is a dedicated area of the Genti Med LLC team. We support Russian and international companies with medical device registration in Russia and the EAEU: from initial product analysis and route selection to dossier preparation, testing, document submission, responses to comments and post-registration support.
Since 2019, the team has worked with medical devices and regulatory projects. At first, we handled registration for our own distribution projects, and since 2020 we have been supporting third-party manufacturers: from minor changes in registration materials and post-clinical reports to full preparation of documents for registration.
The main difference in our approach is that we understand the procedure from both sides: regulatory requirements and the client’s practical business needs. That is why we take into account market-entry timelines, supply risks, project budget and the points where comments most often arise.
How we manage a registration project
We follow a clear route: first we assess the device and source documents, then prepare the dossier, support testing, submission and communication with the participants in the procedure.
Experience, geography and mission of the team
We work with Russian distributors and manufacturers, as well as with international companies from South Korea, China, Turkey, Brazil, Spain, Germany and other countries. For foreign manufacturers, we help adapt documentation to Russian and EAEU requirements, prepare the registration dossier, pass testing and organize project communication.
The team constantly monitors legislative changes and reflects new regulatory practice in documentation and registration routes. Going forward, we are developing expertise in international registration procedures, including areas related to CE marking.
Our mission is to simplify complex regulatory processes so that innovative medical technologies become available to doctors and patients faster.
We handle technical, commercial and registration information carefully. If a project requires confidentiality, we describe our experience in an anonymized format without disclosing clients, devices or commercial details.
