Market Access

Russia / CIS

Expert Guidance for Medical Device Registration in Russia & CIS

Expanding into Russia and the Commonwealth of Independent States (CIS) requires compliance with Eurasian Economic Union (EAEU) regulations and country-specific requirements. At Alpine Quality Consultants, we provide expert support to help medical device manufacturers navigate the complex regulatory landscape in Russia, Kazakhstan, Belarus, Armenia, and Kyrgyzstan.

Our Russia & CIS Medical Device Registration Process

Device Classification & Regulatory Pathway Determination

  • Identify device classification (Class I, IIa, IIb, III) based on EAEU and Russian regulations.
  • Determine the applicable regulatory pathway (national or EAEU conformity assessment).
  • Develop a strategic plan for market entry.

Appointing a Local Authorized Representative

  • Assist in appointing a Local Authorized Representative (LAR) as per Russian and CIS regulations.
  • Manage regulatory communication and submissions with authorities.

Technical Documentation Preparation & Submission

  • Compile a technical dossier including device description, risk assessment, clinical evaluation, and labeling.
  • Ensure compliance with GOST and ISO 13485 quality standards.
  • Submit documentation to the relevant regulatory body (Roszdravnadzor in Russia, other national agencies in CIS countries).

Testing & Regulatory Approval

  • Coordinate local safety, efficacy, and biocompatibility testing as required.
  • Oversee audits and clinical trials if applicable.
  • Address inquiries from authorities and obtain registration certificates.

Post-Market Compliance & Surveillance

  • Ensure compliance with post-market surveillance (PMS) and vigilance reporting.
  • Support in renewals, modifications, and compliance audits.
  • Provide guidance on regulatory updates and maintaining market approval.

RUSSIA / CIS: Russia, Ukraine, Uzbekistan, Belarus, Azerbaijan, Turkmenistan

Alpine Quality Consultants

Your Trusted Partner in Medical Devices & IVDs Technical Consultancy

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