Expert Regulatory Compliance & Product Registration in Russia and EAEU
We specialize in state-mandated registration of medical devices, consumer goods, and industrial products, ensuring full compliance with Russian and EAEU regulations. With 10+ years of experience, our direct partnerships with Roszdravnadzor, Rospotrebnadzor, and key agencies accelerate approvals while minimizing risks.
Unified center of expertise and certification
“Quality” (UCEC QUALITY) – Bridging Global Innovation with Russian Compliance.
Your Trusted Partner in Certification & Regulatory Compliance in Russia and EAEU
Medical Device Registration
Navigate Russia’s stringent regulatory requirements with confidence. We secure timely state registration, validating safety, quality, and efficacy for market approval.
Certification Services
Laboratory testing, documentation, and issuance of certifications required for legal distribution in Russia.
Licensing Support
Obtain licenses for medical device production, maintenance, and related activities—fully aligned with Russian law.
With over a decade of expertise, we streamline the complex landscape of regulatory approvals, certifications, and licensing — ensuring your products meet Russian standards efficiently.
Collaborative Partnerships
We work directly with Russia’s key regulatory bodies:
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Roszdravnadzor (Federal Service for Healthcare Supervision)
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Rospotrebnadzor (Consumer Rights Protection Authority)
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Ministry of Agriculture of Russia
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Rosselkhoznadzor (Agricultural Supervision Agency)
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And other critical institutions.
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Masters of Regulatory Success
What We Deliver:
- Laboratory Testing & Compliance Validation
Rigorous product evaluations aligned with GOST, EAEU, and international standards. - Strategic Regulatory Documentation
End-to-end preparation of technical files, permits, and declarations for swift government approvals. - Certification Across Industries
Mandatory and voluntary certifications for medical devices, consumer goods, and industrial equipment. - Activity-Specific Licensing
Guidance through Russia’s complex licensing frameworks for manufacturing, distribution, and specialized services.
What Sets Us Apart
- Swift Turnaround: Meet deadlines without compromising compliance.
- Full-Spectrum Expertise: Lab testing, legal documentation, and government liaison in one place.
- Cost Transparency: Competitive pricing tailored to your needs.
- Proven Track Record: Hundreds of successful registrations and certifications.
Featured Services
We help you launch your products in Russia and the Eurasian Economic Union (EAEU) quickly and legally. From document submission to obtaining your Registration Certificate, we provide full support every step of the way
Medical Device Registration in Russia
A state registration procedure ensuring the quality and safety of medical products destined for the Russian market.
Medical Device Registration in EAEU
We manage the complete authorization process for importing and selling medical products in Russia. Our service covers every step—from the initial paperwork to securing final registration.
Technical Translation & Documentation
ECEC QUALITY offers fast, accurate technical translations—user manuals, documentation, and more—from English to Russian (and vice versa).
License for Medical Device Manufacturing
We guide you through the licensing process for manufacturing medical equipment, instruments, and other devices.
Documentation for ISO 13485/9001 Certification
Global Standards, Local Expertise
Achieve ISO certification to demonstrate quality management excellence and enhance market credibility.
Development of Technical & Regulatory Documentation
We prepare comprehensive technical documentation for any medical device entering mass production.
successful production audits
years of professional experience
registered medical devices
amendments introduced to registration documents
Our Clients
We collaborate with leading medical equipment manufacturers and technology pioneers worldwide. Our long-term partnerships with industry frontrunners and international market leaders are focused on advancing medical solutions.
Why Choose Us
Over the years, we’ve received countless positive reviews from clients around the world. Here’s why:
Transparent Terms
Every detail is included in the contract, and our extensive experience allows us to set accurate, realistic deadlines.
Best Prices
We work directly with government regulators, eliminating intermediaries and keeping costs competitive.
Global Reach
No matter where you’re located, we’ll ensure the fastest and most efficient service possible.
Insights & Market Analytics
Dive into expert articles, regulatory trends, and market intelligence shaping the future of compliance and certification in Russia and Eurasia EAEU.
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Our experts are ready to help. Contact us now for professional guidance, and we’ll tailor the perfect solution for your needs.