Medical device registration services
Turnkey registration of medical devices
We support turnkey registration: we select a route, prepare a dossier and lead the project until the regulator’s decision.
Registration dossier and VIRD
We help you formalize changes without unnecessary iterations: we evaluate the composition of the amendments, prepare a set of documents and support the submission.
Clinical, toxicological and technical tests
We organize tests according to registration requirements: we select sites, monitor protocols and close the dossier issues.
Authorized representative of the manufacturer
We take on the functions of a representative in the Russian Federation: we communicate with the regulator and maintain product compliance with market requirements.
Production inspection support
We prepare the manufacturer for inspection: we evaluate documents and processes, help to pass the inspection without lengthy modifications.
Post-registration support
We support the product after registration: we monitor changes, update the dossier and help fulfill the requirements of Roszdravnadzor.
How to choose the right support area
Gentimed Consult helps manage medical device regulatory tasks as a single project: from product analysis and route selection to dossiers, testing, submission, comments and post-registration support.
If you are not sure which service you need right now, start with a consultation: we will review the product status, documents, market access route and risks.
How we manage the project
What tasks we cover
Turnkey registration We manage the project from strategy to submission and responses to comments.
Dossiers and amendments We prepare registration materials and changes to existing documents.
Documentation We develop technical, operating and registration documentation.
Testing We organize technical, toxicological and clinical testing.
Authorized representative We support foreign manufacturers and authorized representative tasks.
Inspection and post-registration We support production inspections and post-registration procedures.
Frequently asked questions about services
Where does the work start?
The work starts with initial analysis of the device, risk class, current documents and project goal. After that we can determine the route, scope, timelines and external expenses.
Can the cost be estimated in advance?
Yes, a preliminary estimate can be prepared after reviewing the device and source documentation. Testing, state fees, translations and notarization are usually calculated separately.
Do you work with foreign manufacturers?
Yes. We support foreign manufacturers entering the Russian and EAEU markets, including document adaptation, testing, authorized representative functions and production inspection.
Can you take over only part of the project?
Yes. We can support a separate stage: dossier preparation, testing, amendments, inspection or post-registration tasks.
