Russia & EAEU medical device registration for Chinese and Indian manufacturers
One partner for the entire route to market: risk classification, testing in our own accredited laboratory, the technical file, the registration dossier and post-market support, coordinated with your Russian importer or authorized representative.
Full-cycle support from one accredited group
Regulatory consulting plus our own accredited testing laboratory: from the first classification question to the registration certificate and everything that follows it.
We determine the risk class (1, 2a, 2b, 3), confirm whether your product follows the IVD or the active-device track, and advise whether the national Russian route or the EAEU route fits your product and timeline.
Technical, EMC, electrical safety and toxicological testing, all performed in the group's accredited laboratory (GOST ISO/IEC 17025). Timelines and protocols stay under our roof, not in someone else's queue.
We build the technical documentation, check whether ISO 13485 applies to your class, and help you close the gaps before submission.
We compile and submit the dossier, handle the expert review, and obtain the Russian registration certificate (RU), plus EAEU registration where relevant.
An in-house testing base means the file matches the device, questions get answered fast, and the risk of a refusal goes down.
After registration we maintain the lifecycle: periodic testing, dossier amendments, re-registration, and adding new SKUs from your portfolio.
A foreign manufacturer cannot hold the registration directly
The certificate is issued to a Russian legal entity: your applicant or authorized representative. In practice this is usually your importer or distribution partner, the same company that sells your device. We fix this structure first, because everything else in the project depends on it.
- Foreign manufacturer owns the device and the technical data
- Russian applicant or representative holds the registration
- Importer or distributor is often both the sales channel and the applicant
An accredited in-house lab, not testing on the side
Most market-access agencies are intermediaries: your samples go to a third-party lab, and you inherit its queue and its pricing. Our group runs its own accredited laboratory, so EMC, technical and toxicological testing happen in-house.
Critical for Chinese electronics: diagnostics, monitors, ultrasound and physiotherapy devices.
Performance and safety testing against the standards that apply to your device type.
Biocompatibility evidence for consumables, catheters, single-use items and IVD products, typical for Indian suppliers.
EMC, safety and toxicology stands are part of the group, accredited to GOST ISO/IEC 17025. Protocols are issued by the laboratory itself.
From product to registration
Timelines depend on the risk class, the route (national RF or EAEU) and how complete your documentation is. We give you a realistic plan after the assessment, with no invented numbers up front.
- step 01Assessment
We review the intended use, design, materials and your existing certificates and test reports, then map the regulatory route.
- step 02Applicant and representative
We confirm who holds the registration. A foreign manufacturer needs a Russian applicant or authorized representative.
- step 03Testing and documentation
Testing runs in our accredited lab while we build the technical file and the registration dossier in parallel.
- step 04Registration and lifecycle
You receive the registration certificate. We stay on for post-market obligations and new product registrations.
Every dossier moves through formal stages. The assessment tells you which of them apply to your device and how much time to budget for each.
Market Access Assessment of one product
Every project starts with a paid assessment of a single product. It is a focused regulatory review: risk class, IVD or device track, required testing and the registration route. You get a written deliverable that the whole project is built on.
Risk class, applicable track and standards for your specific device.
Which tests registration requires, and which of them run in our accredited lab.
National RF or EAEU, the applicant structure, and a clear plan to the certificate.
Send us your product brochure, intended use and existing certificates
We will review your materials and reply with the scope and price of a Market Access Assessment for one product. Please write in English.
- Product brochure or catalogue
- Intended use and principle of operation
- Existing certificates (CE, ISO 13485, etc.)
- Available test reports from the manufacturer
- Your intended Russian applicant or partner, if any