About Our Company
Unified Center for Expertise and Certification (UCEC QUALITY)
Since 2015, we’ve provided professional technical consulting and certification services, specializing in medical equipment and pharmaceutical registration. Our headquarters is in St. Petersburg, with a representative office in Ningbo, China. Our modern in-house laboratory enables us to conduct all necessary testing and deliver comprehensive solutions of the highest quality.
OUR SERVICE RANGE
Our years of experience and professional team guarantee your successful entry into the EAEU market. Trust your registration to the experts at UCEC QUALITY!
Consulting
- Expert guidance on medical device registration in Russia and EAEU
- Official representation of interests in EAEU countries
- Assistance with distributor sourcing and negotiations
Preparatory Work
- Medical device classification determination
- Preliminary manufacturing facility audits
- Document translation and notarization
- Apostille verification
Logistics and Testing
- Customs clearance and logistics support for samples
- Testing in accredited EAEU laboratories
- EMC and safety testing for active medical devices in our laboratory
- Clinical trial organization in EAEU medical institutions
- Documentation preparation for EAEU product imports
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.
New QMS Audit Rules for Medical Device Manufacturers in Russia Starting December 1, 2026
Medical device QMS audits in Russia from Dec 1, 2026: new competence requirements for auditors, impact on foreign manufacturers.
Changes to Regulatory Documentation for Medical Devices in Russia in 2026
Russia may update medical device regulatory documentation: unified content, control methods, special rules for AI software, IVD, and implantables.
New Data Transfer Rules for AI-Based Medical Software in Russia
Russia’s new automatic data transfer rules for AI medical devices from May 23, 2026 — scope, required data, electronic account access, and who is responsible.
Explore Insights & Articles
Company News
Medical Device Registration Service in Russia Will Be Updated on June 2, 2026
June 2, 2026: Gosuslugi updates Russia’s medical device registration service — drafts may be deleted, some applications need re-entry. Check status now.
Eco Fee Reporting in Russia Must Be Submitted by April 15, 2026
April 15, 2026 deadline for Russia’s eco fee reporting: which companies must file under EPR, what forms are required, and the most common calculation mistakes to avoid.
93rd China International Medical Equipment Fair CMEF 2026
Join UCEC Quality LLC at CMEF 2026 to discuss medical device registration, certification, and market access in Russia and the EAEU.
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Get Expert Advice from Our Specialists
Our experts are ready to help. Contact us now for professional guidance, and we’ll tailor the perfect solution for your needs.