Russia & EAEU medical device registration for Chinese and Indian manufacturers
One partner for the full route to market: classification, testing in our own accredited laboratory, technical file, registration dossier and post-market support - coordinated with your Russian importer or authorized representative.
Full-cycle support, one accredited group
Consulting plus our own accredited testing laboratory - from determining the regulatory route to obtaining the registration certificate and maintaining it afterwards.
We determine the risk class (1 / 2a / 2b / 3), the correct IVD or active-device track, and whether the national Russian route or the EAEU route fits your product and timeline.
Technical, EMC, electrical-safety and toxicological / biological testing performed in the group's own accredited laboratory (GOST ISO/IEC 17025), so timelines and protocols stay under our control.
We build the technical documentation, assess whether ISO 13485 is required for your class, and help close the gaps before submission.
We compile and submit the registration dossier, manage the expert review and obtain the Russian registration certificate (RU) and, where relevant, EAEU registration.
An accredited in-house testing base means fewer hand-offs, fewer mismatches between the file and the device, and a lower risk of refusal.
After registration we maintain the lifecycle: periodic testing, dossier amendments, re-registration and adding new SKUs from your portfolio.
A foreign manufacturer needs a Russian applicant or authorized representative
The registration certificate is issued to a Russian legal entity acting as the applicant / authorized representative. In practice this is often your importer or local distribution partner - who is also your route to the market. We help define this early, because the entire registration plan depends on it.
- Foreign manufacturer - owns the device and technical data
- Russian applicant / representative - holds the registration
- Importer / distributor - often both the channel and the applicant
An accredited in-house lab, not testing on the side
Most market players are intermediaries without a testing base: your testing goes to a third-party lab, and you depend on its queue and pricing. Our group runs its own accredited laboratory - EMC, technical and toxicological testing in-house.
Essential for Chinese electronics, diagnostics, monitors, ultrasound and physiotherapy devices.
Performance and safety testing aligned with the applicable standards for your device type.
Biocompatibility evidence for consumables, catheters, single-use and IVD products typical of Indian suppliers.
From product to registration
Timelines depend on the risk class, the route (national RF or EAEU) and the completeness of the manufacturer's documentation. We give you a realistic plan after the assessment - no invented numbers up front.
- 01AssessmentWe review the intended use, design, materials and the manufacturer's existing certificates and test reports, then map the regulatory route.
- 02Applicant & representativeWe confirm who will hold the registration - a Russian applicant / authorized representative is required for a foreign manufacturer.
- 03Testing & documentationRequired testing runs in our accredited lab in parallel with building the technical file and registration dossier.
- 04Registration & lifecycleWe obtain the registration certificate and continue with post-market obligations and new product registrations.
Market Access Assessment of one product
We start with a paid Market Access Assessment of a single product. It is a focused regulatory review - risk class, IVD / device track, required testing and the registration route - and the deliverable you build the project on.
Risk class, applicable track and standards for your specific device.
The set of tests needed for registration, and which run in our accredited lab.
National RF vs EAEU, the applicant structure and a clear plan to registration.
Send your product brochure, intended use and existing certificates or test reports
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 / catalogue
- Intended use and principle of operation
- Existing certificates (CE, ISO 13485, etc.)
- Available test reports from the manufacturer
- Your intended Russian applicant / partner, if any