Russia Product Registration & Certification
Important Notes
- Mandatory State Registration: All medical devices, cosmetics and Biologically Active Supplements (БАД) require compulsory state registration with respective regulatory authorities before marketing.
- Local Authorized Representative Requirement: Foreign manufacturers must appoint an authorized representative within Russia (local company) responsible for application submission, technical documentation, regulatory communication and product liability.
- Technical Documentation & Local Testing: Complete Russian technical documentation required, with most products undergoing mandatory local testing in accredited Russian laboratories.
- Criticality of Product Classification: Must accurately classify products as medical devices, cosmetics or Biologically Active Supplements (БАД), each with completely different registration pathways and requirements.
- Special Regulation of БАД: Biologically Active Supplements (БАД) are managed as an independent category; labeling must clearly indicate "БАД" designation, with claims strictly limited to nutritional support and prohibiting any therapeutic claims.
- EAEU Compliance Consideration: Assess if products must meet Eurasian Economic Union unified technical requirements; some products may pursue EAEU registration as alternative to Russian national registration.
Russia specific Requirements
- Independent & Highly Centralized Regulatory System: Russia operates independent registration and oversight systems for medical devices, cosmetics and БАД, with processes strictly controlled by central government.
- "Import Substitution" Strategy Drives Localization: Policies actively promote localization of healthcare product manufacturing, offering review incentives and market advantages for locally produced or technology-transferred products.
- Technological Sovereignty & Local Verifiability: Emphasizes "local verifiability" of technical documentation, mandating testing in Russian labs and preferring local clinical data and expert reviews.
- Strict Regulation of БАД Market: While the Biologically Active Supplements (БАД) market is growing rapidly, regulation is becoming increasingly stringent with high demands for safety evidence and claim management.
- Public Procurement Dominance & Geopolitical Risks: State procurement is the main market driver, while international sanctions and supply chain instability require flexible strategies and strong local partnerships.
Medical Devices Registration
Regulatory Requirements
- Medical Device State Registration Certificate
- Classification Management by Risk Level (Class 1, 2a, 2b, 3)
- Complete Russian Technical Documentation and Test Reports
- Quality Management System Certificate (GOST R ISO 13485)
- Russian Labeling and Instructions for Use
- EAC Declaration of Conformity or Certification
- Local Clinical Trials (Class 2b, 3 devices)
- Technical Specification File (TSF)
- State Registration Number (GRN) Assignment
Main Process
- Product Classification Determination
- Technical Documentation Preparation
- Local Testing Completion
- EAC Certification Acquisition
- Roszdravnadzor Review
- Registration Certificate Acquisition
Registration Timeline
18-36 months
Official Fees
RUB 800,000 - 5,000,000
Service Fees
$35,000 - $90,000
Regulatory System Overview
Roszdravnadzor
Federal Service for Surveillance in Healthcare
Responsible for state registration approval, quality supervision, post-market safety monitoring, and market regulation of medical devices and pharmaceuticals. Operates as the supreme healthcare product regulatory authority under the Russian Ministry of Health.
Rospotrebnadzor
Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing
Responsible for state registration approval, market surveillance, and consumer rights protection for cosmetics, Biologically Active Supplements (БАД), food and other consumer products
FGIS "SES"
Federal State Information System "Sanitary-Epidemiological Surveillance"
Responsible for technical evaluation, safety and efficacy review of БАД, providing scientific basis for Rospotrebnadzor registration decisions
Medical Devices Registration Process
Product Classification Determination
Determine medical device risk classification according to Russia medical device regulations (Class 1, 2a, 2b, 3)
Technical Documentation Preparation
Prepare complete Russian technical documentation including technical specification file, test reports
Local Testing and Certification
Complete local testing in accredited Russian laboratories and obtain EAC certification
Registration Application Submission
Submit medical device state registration application to Roszdravnadzor
Expert Committee Review
Pass expert committee review to obtain state registration certificate
Cosmetics Registration
Regulatory Requirements
- State Registration Certificate (SGR)
- Ingredient Formula Safety Assessment Report
- Russian Product Labeling
- Good Manufacturing Practice Certification
- Toxicological Test Reports
- Microbiological Test Reports
- Stability Study Data
- EAC Declaration of Conformity
Main Process
- Ingredient Formula Assessment
- Safety Documentation Preparation
- Local Testing Completion
- State Registration Submission
- EAC Certification Acquisition
Registration Timeline
9-18 months
Official Fees
RUB 300,000 - 1,200,000
Service Fees
$15,000 - $35,000
Regulatory System Overview
Roszdravnadzor
Federal Service for Surveillance in Healthcare
Responsible for state registration approval, quality supervision, post-market safety monitoring, and market regulation of medical devices and pharmaceuticals. Operates as the supreme healthcare product regulatory authority under the Russian Ministry of Health.
Rospotrebnadzor
Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing
Responsible for state registration approval, market surveillance, and consumer rights protection for cosmetics, Biologically Active Supplements (БАД), food and other consumer products
FGIS "SES"
Federal State Information System "Sanitary-Epidemiological Surveillance"
Responsible for technical evaluation, safety and efficacy review of БАД, providing scientific basis for Rospotrebnadzor registration decisions
Cosmetics Registration Process
Ingredient Formula Assessment
Evaluate all ingredients for compliance with Russia cosmetic regulations
Safety Documentation Preparation
Prepare Russian safety assessment report and technical documentation
Local Testing
Complete toxicological and microbiological testing in accredited Russian laboratories
State Registration Submission
Submit cosmetic state registration application to Rospotrebnadzor
EAC Compliance
Obtain Eurasian Economic Union EAC declaration of conformity or certification
Biologically Active Supplements (БАД) Registration
Regulatory Requirements
- State Registration Certificate (SGR)
- Scientific Evidence of Ingredient Safety and Efficacy
- Russian Product Labeling (must include "БАД" designation)
- Good Manufacturing Practice Compliance Proof
- Local Test Reports from Accredited Russian Laboratories
- Ingredient Specifications, Purity and Quality Standards
- Stability Study and Shelf-life Data
- EAC Declaration of Conformity (where applicable)
- Manufacturer Qualifications and Authorization Documents
Main Process
- Product Qualification as БАД
- Complete Russian Technical Documentation Preparation
- Safety and Efficacy Testing in Russian Laboratories
- State Registration Application to Rospotrebnadzor
- Expert Committee Technical Review
- State Registration Certificate Acquisition
Registration Timeline
12-24 months
Official Fees
RUB 400,000 - 1,800,000
Service Fees
$20,000 - $45,000
Regulatory System Overview
Roszdravnadzor
Federal Service for Surveillance in Healthcare
Responsible for state registration approval, quality supervision, post-market safety monitoring, and market regulation of medical devices and pharmaceuticals. Operates as the supreme healthcare product regulatory authority under the Russian Ministry of Health.
Rospotrebnadzor
Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing
Responsible for state registration approval, market surveillance, and consumer rights protection for cosmetics, Biologically Active Supplements (БАД), food and other consumer products
FGIS "SES"
Federal State Information System "Sanitary-Epidemiological Surveillance"
Responsible for technical evaluation, safety and efficacy review of БАД, providing scientific basis for Rospotrebnadzor registration decisions
Biologically Active Supplements (БАД) Registration Process
БАД Qualification Confirmation
Confirm product meets legal definition of "Biologically Active Supplements (БАД)", not drugs or general food
Technical Documentation Preparation
Prepare complete Russian technical documentation including ingredient analysis, safety and efficacy scientific basis
Local Testing
Complete necessary safety, microbiological and physicochemical testing in accredited Russian laboratories
State Registration Application
Submit БАД state registration application and all technical documents to Rospotrebnadzor
Expert Review & Approval
Pass technical review by expert committee to obtain БАД State Registration Certificate