Roszdravconsult is a regulatory consultancy dedicated to facilitating medical device registration and compliance in the Russian Federation and other EAEU jurisdictions.
Our mission
To accelerate patient access to innovative healthcare solutions by delivering a transparent, predictable, and streamlined registration process for medical device manufacturers.
Our expertise
Full-spectrum registration support for Class I–III medical devices. Expertise grounded in deep familiarity with Roszdravnadzor guidelines and harmonized EAEU regulatory frameworks. Proactive regulatory intelligence: real-time tracking of key legislative acts (e.g., RF Government Decrees № 1684, № 2214; EEC Council decisions) to ensure ongoing compliance.
Partnerships
Our ecosystem includes 9 accredited test labs, 5 experienced clinical investigation centers, and premier legal partners ensuring end-to-end regulatory support.
Regulatory Approval Services
End-to-end regulatory guidance throughout the entire medical device registration lifecycle.
- Expert support in technical dossier compilation and end-to-end management of medical device registration processes
- Appointment of an Authorized Representative established in the EAEU or Russia is a mandatory requirement for foreign manufacturers seeking registration and continued validity of their medical device certificates.
- Changes to the design, composition, labeling, or intended use of a registered medical device require submission of a variation application to update the Registration Certificate.
- From 2026 onward, all nationally issued Registration Certificates must be transitioned to the EAEU framework through re-registration or certificate actualization.
- We handle all post-registration regulatory responsibilities including vigilance reporting, dossier maintenance, and timely submissions to Roszdravnadzor ensuring your medical devices remain legally marketable and compliant throughout their lifecycle.
- Avoid costly delays and rejections. Our pre-submission audit evaluates your technical file, classification, and evidence package against current requirements, highlighting risks and providing a clear roadmap to successful registration.
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Since 2020, we have successfully supported over 30 manufacturers from 12 countries in gaining market access for medical devices in Russia and CIS
Contact us today to receive:
• Preliminary cost estimate for regulatory registration
• Risk classification assessment of your medical device
• Expert recommendations on the optimal registration strategy
• Risk classification assessment of your medical device
• Expert recommendations on the optimal registration strategy
