Streamlined Market Access for Medical Devices
Across the CIS Region
The CIS (Commonwealth of Independent States) countries offer a promising but complex market for medical devices. With a mix of local regulatory systems and growing integration into the Eurasian Economic Union (EAEU) framework, manufacturers must navigate evolving requirements, language barriers, and documentation standards to achieve timely approvals.
🌏 CIS Countries We Serve
Ministry of Health Submissions
EAEU Framework Submissions
Local Regulatory Submissions
Local Regulatory Submissions
Regulatory Services for Medical Devices Across the CIS Region
At RABT Global, we specialize in delivering Regulatory Services for Medical Devices across the CIS region. From classification and technical file preparation to authority submissions and post-market support.
🇺🇿 Uzbekistan
🇧🇾 Belarus
🇦🇲 Armenia
🇰🇬 Kyrgyzstan
🇦🇿 Azerbaijan
🇬🇪 Georgia
🇹🇯 Tajikistan
🇹🇲 Turkmenistan
🤝 Let’s Begin: Looking to register your medical devices in CIS countries or under EAEU procedures? RABT Global ensures a clear and compliant path to success.
Your Trusted Regulatory Partner in the CIS Region
Local Language & Cultural Fluency for effective documentation and communication
On-Ground Presence through partnerships with agents and consultants
Full Lifecycle Support from strategy to post-approval compliance
Our Services Cover
We ensure your compliance and successful entry into these emerging markets — from classification and technical file preparation to authority submissions and post-market support.
Regulatory Strategy & Classification
Medical device classification and conformity assessment planning. Strategic roadmap for dossier preparation and submissions.
Strategy
Technical Documentation & Submission
Translation into Russian and local languages. Compilation of technical files, risk assessments, clinical data, and QMS evidence. Submission to authorities including Kazakhstan Ministry of Health, Uzbekistan, Belarus, Armenia, and others.
Technical Dossier
EAEU Medical Device Registration
Preparation of Common Technical Documents (CTD). Device listing, approval, and coordination with EAEU-recognized notified bodies.
EAEU
Local Representation & Agent Services
Legal and regulatory interface with national authorities. Coordination with local agents for submissions and product monitoring.
Local Representation
Labeling, Translation & Packaging Review
Certified Russian and local language translations. Ensuring alignment with country-specific and EAEU packaging standards.
Labeling
Post-Market Surveillance & Regulatory Maintenance
Adverse event monitoring, FSCA handling, and periodic updates. Renewals, variations, and ongoing regulatory support.
Post-Market
CIS Countries We Serve
RABT Global supports medical device regulatory submissions and post-approval services across the CIS region.
EAEU Member States
Kazakhstan, Belarus, Armenia, Kyrgyzstan
Kazakhstan
Belarus
Armenia
Kyrgyzstan
Other CIS Countries
Uzbekistan, Azerbaijan, Georgia, Tajikistan, Turkmenistan
Uzbekistan
Azerbaijan
Georgia
Tajikistan
Turkmenistan