Russia maintains a well-established product compliance framework governed by national technical regulations (TRs) under the Eurasian Economic Union (EAEU) system. Products imported into or sold in Russia must meet EAEU conformity requirements, with mandatory certification or declaration, and comply with national rules for labeling, telecom, safety, and environmental protection.

Key Authorities:

• Federal Agency on Technical Regulating and Metrology (Rosstandart) – Coordinates development of GOST and EAEU standards, and maintains Russia’s national certification infrastructure.

• Federal Service for Surveillance in Healthcare (Roszdravnadzor) – Regulates pharmaceuticals, medical devices, and health-related products.

• Federal Service for Supervision of Communications, Information Technology and Mass Media (Roskomnadzor) – Oversees telecom and RF equipment, including type approval and licensing.

• Federal Customs Service – Enforces conformity documentation for imports and works closely with certification bodies.

Key Compliance Elements:

• EAEU Certification System:

  • Products must comply with one or more EAEU Technical Regulations (TR CU or TR EAEU), such as:

    • TR CU 004/2011 (low-voltage equipment)

    • TR CU 020/2011 (electromagnetic compatibility)

    • TR CU 007/2011 (product safety for children)

  • Based on the product category, two options exist:

    • Declaration of Conformity (DoC) – Manufacturer/importer self-declares with test evidence

    • Certificate of Conformity (CoC) – Issued by an accredited certification body

  • Approved products must bear the EAC mark.

• Product Registration (Roszdravnadzor):

  • Required for:

    • Pharmaceuticals and vaccines

    • Medical devices

    • Sanitary and epidemiological products (e.g., disinfectants, supplements)

  • Registration involves:

    • Submission of a technical dossier

    • Local testing or recognition of foreign test data (depending on the product)

    • Labeling in Russian

    • Certificate of state registration

• Telecom Equipment (Roskomnadzor / Ministry of Digital Development):

  • All RF and telecom devices require:

    • Type approval (if using licensed frequencies)

    • Declaration or certification of conformity to TR CU 020/2011

    • Notification to Roskomnadzor before market entry

• Labeling Requirements:

  • Labels must be in Russian, and include:

    • Product name

    • Country of origin

    • Manufacturer/importer name and contact

    • Instructions for use and safety warnings

    • EAC mark (if applicable)

    • Expiry/batch number (for regulated goods)

• Import Oversight:

  • Importers must provide:

    • Certificate or Declaration of Conformity (TR CU or TR EAEU)

    • Certificate of state registration (for health-related goods)

    • Invoice, packing list, and customs declaration

    • Certificate of origin (preferably under EAEU form)

• Market Surveillance:

Carried out by Rospotrebnadzor, Roszdravnadzor, and Customs, focusing on documentation checks, sampling, and technical audits. Violations may result in fines, confiscation, or suspension of sales.