Registration of Medical Devices in Russia & EAEU
Obtaining a Registration Certificate (RC) is a mandatory requirement for the legal circulation of medical devices in the Russian Federation and EAEU member states.
What’s Included:
✓ Risk classification analysis (Class I, IIa, IIb, III)
✓ Development and compilation of complete technical documentation
✓ Preparation of Instructions for Use (IFU) and labeling
✓ Organization and management of laboratory testing
✓ Coordination of clinical trials/evaluations (if applicable)
✓ Toxicological and biocompatibility studies
✓ Application submission to Roszdravnadzor via the official regulatory portal
✓ Expert review support and response to regulatory queries
✓ Issuance of the Registration Certificate
✓ Entry into the State Registry of Medical Devices
Processing Timelines:
• Class I: 6–9 months
• Class IIa: 8–12 months
• Class IIb: 10–15 months
• Class III: 12–18 months
Pricing: Starting from 350,000 RUB/ 5000 USD (final cost depends on risk class and device type)

Authorized Representative Services | Russia & EAEU
Foreign manufacturers are required to appoint an Authorized Representative (AR) within the Eurasian Economic Union (EAEU) to obtain and maintain valid Registration Certificates for medical devices.
Key Functions of Your Authorized Representative:
✓ Representation of manufacturer's interests before Roszdravnadzor and other regulatory bodies
✓ Submission of registration applications and variation/amendment filings
✓ Management and continuous updating of the registration dossier
✓ Receipt and secure storage of device samples for regulatory purposes
✓ Ongoing liaison with regulatory authorities throughout the product lifecycle
✓ Post-market surveillance (PMS) and safety monitoring
✓ Collection and assessment of adverse event reports and field safety notices
✓ Mandatory incident reporting to Roszdravnadzor within regulatory timelines
✓ Coordination of field safety corrective actions (FSCA) and recall campaigns (if required)
✓ Archiving of technical documentation per EAEU retention requirements
AR Eligibility Requirements (2026):
• Legal entity registered in an EAEU member state
• Dedicated qualified regulatory personnel
• Valid Power of Attorney (PoA) from the manufacturer
• Implemented Quality Management System (QMS) compliant with ISO 13485 / EAEU guidelines
Pricing: Starting from 150,000 RUB/2000 USD/year
(Final fee depends on the number of registered devices and scope of post-market support)

Variations & Amendments to Registration Certificates | Russia & EAEU
Any modification to a registered medical device requires formal variation filing to update the Registration Certificate (RC) and maintain regulatory compliance.
When a Variation Filing Is Required:
→ Changes to device design, composition, or materials
→ Change of manufacturer or production site
→ Modification of intended purpose or indications for use
→ Updates to Instructions for Use (IFU) or labeling
→ Change of Authorized Representative (AR)
→ Revision of storage conditions or shelf life
→ Software/firmware upgrades or digital component updates
Scope of Service:
✓ Regulatory impact assessment of proposed changes
✓ Determination of need for additional laboratory/clinical testing
✓ Preparation and compilation of variation dossier
✓ Submission of application to Roszdravnadzor via official regulatory portal
✓ Expert review support and response to regulatory queries
✓ Issuance of amended Registration Certificate (RC)
Processing Timelines:
• Substantial variations: 3–6 months
• Non-substantial variations: 1–3 months
(Timelines are indicative and subject to regulatory authority workload)
Pricing: Starting from 150,000 RUB/2000 USD
(Final fee depends on variation complexity, testing requirements, and number of affected Registration Certificates)

EAEU Transition & Re-registration Services | Russia & EAEU
Starting from 2026, Registration Certificates (RC) issued under national procedures require re-registration or actualization to comply with the updated Eurasian Economic Union (EAEU) regulatory framework.
Key Transition Deadlines:
→ Until 31.12.2027 — Option to submit applications under national procedures
→ Until 31.12.2028 — Validity period for national RCs eligible for transition to EAEU format
Scope of Service:
✓ Audit of current registration dossier and gap analysis vs. EAEU requirements
✓ Actualization and harmonization of technical documentation per EAEU standards
✓ Support in obtaining ISO 13485 certification (if required for EAEU compliance)
✓ Preparation of new application package aligned with EAEU Decision No. 46
✓ Formal submission to Roszdravnadzor via the unified regulatory portal
✓ Expert review coordination and response to regulatory queries
Processing Timelines:
• Standard transition: 4–8 months
(Timelines are indicative and subject to regulatory authority workload and dossier completeness)
Pricing: Starting from 250,000 RUB/3300 USD
(Final fee depends on dossier complexity, number of RCs under transition, and need for supplementary testing or ISO certification)

Post-Market Surveillance & RC Maintenance | Russia & EAEU
Ongoing support to maintain the validity of Registration Certificates (RC) and ensure compliance with post-marketing surveillance requirements for medical devices in the Eurasian Economic Union.
Scope of Service:
✓ Market safety monitoring and vigilance activities for registered devices
✓ Systematic collection and documentation of adverse event reports
✓ Incident investigation, risk assessment, and trend analysis
✓ Preparation and submission of periodic safety reports to Roszdravnadzor
✓ Liaison with healthcare institutions and end-users for field feedback
✓ Coordination of Field Safety Corrective Actions (FSCA) and preventive measures
✓ Continuous update and maintenance of the registration dossier
✓ Annual regulatory reporting and compliance documentation
Pricing: Starting from 100,000 RUB/1300 USD /year
(Final fee depends on device risk class, market volume, and scope of post-market support required)

Pre-Registration Assessment & Regulatory Strategy | Russia & EAEU
Expert evaluation of your medical device's readiness for registration and proactive identification of potential regulatory risks before submission.
Service Options:
✓ Documentation gap analysis: Assessment of current technical files against EAEU/Roszdravnadzor requirements
✓ Quality system audit: Review of manufacturer's Quality Management System (QMS) for regulatory compliance
✓ Preliminary classification: Determination of risk class (I, IIa, IIb, III) and EAEU product code
✓ Registration strategy development: Customized roadmap for optimal market entry pathway and timeline
✓ Regulatory training: Staff workshops on EAEU requirements, PMS obligations, and submission best practices
Pricing: Starting from 50,000 RUB
(Final fee depends on device complexity, scope of assessment, and deliverable format — report, presentation, or consultation session)