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.
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, we ensure your compliance and successful entry into these emerging markets.
Our Services Cover:
1. Regulatory Strategy & Classification
Country-specific and EAEU regulatory intelligence
Medical device classification and conformity assessment planning
Strategic roadmap for dossier preparation and submissions
2. Technical Documentation & Submission
Preparation of CSDT, STED, and EAEU-compliant dossiers
Translation into Russian and local languages
Compilation of technical files, risk assessments, clinical data, and QMS evidence
Submission to authorities including:
Roszdravnadzor (Russia)
Kazakhstan Ministry of Health
Uzbekistan, Belarus, Armenia, and others
3. EAEU Medical Device Registration
Guidance for registration under EAEU Unified Procedures
Preparation of Common Technical Documents (CTD)
Device listing, approval, and coordination with EAEU-recognized notified bodies
4. Local Representation & Agent Services
Appointment of in-country authorized representatives
Legal and regulatory interface with national authorities
Coordination with local agents for submissions and product monitoring
5. Labeling, Translation & Packaging Review
Regulatory review of labels, IFU, and artwork
Certified Russian and local language translations
Ensuring alignment with country-specific and EAEU packaging standards
6. Post-Market Surveillance & Regulatory Maintenance
Setup of PMS systems and vigilance reporting
Adverse event monitoring, FSCA handling, and periodic updates
Renewals, variations, and ongoing regulatory support
CIS Countries We Serve
Russia (Roszdravnadzor)
Kazakhstan
Uzbekistan
Belarus
Armenia
Kyrgyzstan
Azerbaijan
Georgia
Tajikistan
Turkmenistan
Why Partner with RABT Global?
CIS & EAEU Market Experts with a track record in multi-country projects
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
Let’s Begin Your CIS Market Journey
Looking to register your medical devices in CIS countries or under EAEU procedures?
RABT Global ensures a clear and compliant path to success.
