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Registration of Medical Devices
Medical Device Registration in Russia Medical Device Registration in EAEU Registration Dossier Amendments Cancel Medical Device Registration Official Inquiry to Roszdravnadzor Registration Dossier Development Medical Device Testing Authorized Representative (AR) Services for Medical Devices in Russia & EAEU
Quality Management System
QMS Development & Implementation for Medical Devices in Russia & EAEU QMS Inspection Support for Medical Device Manufacturers QMS Certification Assistance for Medical Device Manufacturers
Intellectual Property
Trademark Registration in Russia & International Invention Registration in Russia Utility Model Registration in Russia Software Registration in Russia Copyright
Dietary Supplement Registration Product Certification & Declaration Product Certification Exemption Letter Construction Materials Testing Fire Safety Compliance Certification for Products
Licensing
Medical Activity License in Russia Medical Equipment Maintenance License in Russia
Pricing Reviews About Us FAQ Contact Us
Home
Services
Registration of Medical Devices
Medical Device Registration in Russia Medical Device Registration in EAEU Registration Dossier Amendments Cancel Medical Device Registration Official Inquiry to Roszdravnadzor Registration Dossier Development Medical Device Testing Authorized Representative (AR) Services for Medical Devices in Russia & EAEU
Quality Management System
QMS Development & Implementation for Medical Devices in Russia & EAEU QMS Inspection Support for Medical Device Manufacturers QMS Certification Assistance for Medical Device Manufacturers
Intellectual Property
Trademark Registration in Russia & International Invention Registration in Russia Utility Model Registration in Russia Software Registration in Russia Copyright
Dietary Supplement Registration Product Certification & Declaration Product Certification Exemption Letter Construction Materials Testing Fire Safety Compliance Certification for Products
Licensing
Medical Activity License in Russia Medical Equipment Maintenance License in Russia
Pricing Reviews About Us FAQ Contact Us
+7 981 940 28 59
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Pricing & Plans

We offer a comprehensive range of regulatory, quality, and intellectual property services for the Russian and EAEU markets. All prices are in Dollars (USD) and represent starting costs. Final project pricing depends on the scope of work, device complexity, and specific client needs.

Service Description Starting Price (USD)

Pricing for Medical Device Registration Pricing for Medical Device Registration

  
Medical Device Registration in Russia  
Risk Class 1 from $4 900
Risk Class 2a (non-sterile) from $6 750
Risk Class 2a (sterile) from $7 950
Risk Class 2b from $9 800
Risk Class 3 from $11 650
Medical Device Registration in EAEU  
Risk Class 1 from $6 750
Risk Class 2a (non-sterile) from $9 200
Risk Class 2a (sterile) from $10 430
Risk Class 2b from $12 270
Risk Class 3 from $14 110
Registration Dossier Amendments (VIRD)  
National (RF) – without expert examination from $860
National (RF) – with expert examination from $1 840
EAEU procedure from $3 680
Cancellation of Registration Certificate from $615
Submission of Official Inquiry to Roszdravnadzor from $245
Registration Dossier Documentation Development  
Technical Documentation (Technical File) from $615
Instructions for Use/Operational Documentation from $550
Power of Attorney for Authorized Representative from $430
Risk Management File (GOST ISO 14971) from $895
Usability Engineering File from $980
Factory Qualification Test Report & Protocol from $370
Software Lifecycle Processes File from $210
Photographic Images of the Medical Device from $295
Labeling Documentation (text & images) from $295
Document “Information on Normative Documentation” from $185
Notification of Sample Import from $185
Information/Documentation for Clinical Trials (predicate search, literature review, justification) from $550
Document confirming Compliance with General Safety and Efficacy Requirements, Labeling and Operational Documentation Requirements from $945
Post-Market Surveillance Plan from $1 045
Clinical Evidence Report for Medical Device Efficacy and Safety based on manufacturer’s clinical data from $1 475
Medical Device Testing Organization & Management  
Technical Testing from $640
Electromagnetic Compatibility (EMC) Testing from $560
Testing for Type Approval of Measuring Instruments from $560
Toxicological / Biological Safety Testing from $400
Clinical / Clinical‑Laboratory Trials from $400
Authorized Representative (AR) Services (Monthly Retainer)  
Risk Class 1 from $245
Risk Class 2a from $490
Risk Class 2b from $735
Risk Class 3 from $980

Pricing for Quality Management System (QMS) Pricing for Quality Management System (QMS)

  
QMS Development & Implementation for Medical Devices in Russia & EAEU  
QMS Development & Implementation for Medical Device Manufacturing from $3 100
Internal QMS Audit (compliance with Government Resolution No. 136) from $1 850
Support during QMS Production Inspection from $550
Assistance with QMS Certification from $3 700

Pricing for Intellectual Property Services Pricing for Intellectual Property Services

  
Trademark Registration (Russia)  
Word Mark from $900
Figurative Mark from $900
Combined Mark from $980
Word + Figurative (two marks) from $1 470
International Trademark Application (Madrid System) from $1 550
Invention Registration Upon Request
Utility Model Registration Upon Request
Software Registration from $370
Copyright Deposit from $210

Pricing for Dietary Supplement Registration Pricing for Dietary Supplement Registration

 from $3 680

Pricing for Product Certification & Declaration Pricing for Product Certification and Declaration

  
TR CU (EAEU) Conformity Upon Request
GOST R Conformity Upon Request

Pricing for Product Certification Exemption Letter Pricing for Product Certification Exemption Letter

 from $60

Pricing for Construction Materials Testing Management Pricing for Construction Materials Testing

 15% of test cost

Pricing for Fire Safety Compliance Certification Support Pricing for Fire Safety Compliance Certification

 15% of test cost

Pricing for Licensing Pricing for Licensing

  
Medical Activity License  
New Medical Activity License Acquisition from $2 500
License Amendments (single address, ≤10 outpatient services) from $625
License Amendments (multiple addresses, >10 services) from $1 250
License Amendments (cessation of activities) from $375
License Cancellation from $185
Medical Equipment Maintenance License  
New Medical Equipment Maintenance License Acquisition from $3 750
License Amendments (change of address, works/services) from $625
License Amendments (other cases) from $1 850
License Cancellation from $185

 

Special Terms for Long-Term Partnerships:

When contracting two or more projects, we offer a discount of up to 15% on the total service cost.

For complex, multi-project engagements, we provide flexible, custom pricing – contact us to discuss your goals.

 

Ready to start your project? Contact us to discuss your needs and receive a detailed, obligation‑free proposal. We’ll work with you to structure the most efficient and cost‑effective solution.

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