Mongolia maintains a structured product compliance framework that focuses on consumer protection, technical regulation, and public health, with growing alignment to international standards such as ISO, IEC, and Codex Alimentarius. The system includes mandatory certification for certain goods and regulatory oversight for pharmaceuticals, food, electronics, and telecom products.

Key Authorities:

• Mongolian Agency for Standardization and Metrology (MASM) – National standards body responsible for developing Mongolian Standards (MNS), coordinating conformity assessment, and accrediting test laboratories.

• General Agency for Specialized Inspection (GASI) – Conducts market surveillance, product testing, and import inspections.

• Ministry of Health (MoH) – Regulates pharmaceuticals, medical devices, food safety, and health supplements.

• Communications Regulatory Commission (CRC) – Manages type approval for telecom and RF equipment.

• Mongolian Customs General Administration – Ensures imported goods comply with regulatory and documentation requirements.

Key Compliance Elements:

• Certification & Standards:

  • Certain categories (e.g., electrical appliances, construction materials, toys) must comply with MNS standards.

  • Products may need a Certificate of Conformity issued by a MASM-accredited body, based on testing and document review.

  • MASM standards are often harmonized with international norms (ISO/IEC).

• Product Registration:

  • Required for:

    • Pharmaceuticals and vaccines

    • Medical devices and diagnostics

    • Cosmetics and food supplements

  • Managed by the Ministry of Health, and includes:

    • Safety and efficacy data

    • GMP certificates

    • Labeling and language compliance (in Mongolian)

• Telecom Type Approval (CRC):

  • All RF and telecom equipment must be approved before import or sale.

  • Requires submission of technical documentation, user manuals, and test reports (CE/FCC accepted as references).

  • Approved products are issued a type approval certificate.

• Labeling Requirements:

  • Labels must be in Mongolian, and include:

    • Product name

    • Country of origin

    • Manufacturer/importer details

    • Instructions and safety warnings

    • Expiry date or batch number (if applicable)

    • Certification mark or approval ID (if regulated)

• Import Oversight:

  • Required documents:

    • Invoice and packing list

    • Certificate of origin

    • Product registration certificate (MoH-regulated goods)

    • Certificate of Conformity (for regulated categories)

    • Telecom type approval (CRC, if applicable)

• Market Surveillance:

  • GASI conducts inspections at entry points and in retail markets to detect non-compliant, counterfeit, or expired products.