Sudan has an evolving product compliance framework, primarily focused on consumer safety, public health, and import quality control. Due to ongoing political and economic challenges, the country relies heavily on import regulations, international standards, and recognized foreign certifications to ensure product compliance.

Key Authorities:

• Sudanese Standards and Metrology Organization (SSMO) – Responsible for developing and enforcing Sudanese National Standards (SNS) and issuing Certificates of Conformity (CoC).

• National Medicines and Poisons Board (NMPB) – Regulates pharmaceuticals, medical devices, health supplements, and cosmetics.

• Telecommunications and Post Regulatory Authority (TPRA) – Oversees telecom and RF equipment regulation, including type approval and spectrum management.

• Sudan Customs Authority – Verifies compliance documentation and enforces import regulations at entry points.

Key Compliance Elements:

• Standards and Certification (SSMO):

  • Applies to regulated products including:

    • Electrical appliances

    • Food products

    • Construction materials

  • Products may require:

    • Certificate of Conformity (CoC) issued by SSMO or a recognized foreign body

    • Compliance with ISO, IEC, or other international standards

• Product Registration (NMPB):

  • Required for:

    • Medicines and vaccines

    • Medical devices and diagnostics

    • Food supplements and cosmetics

  • Registration involves:

    • Submission of product dossiers and safety data

    • GMP certification and Certificates of Free Sale

    • Labels in Arabic or English

    • Import permits for regulated goods

• Telecom Type Approval (TPRA):

  • Mandatory for all telecom and RF devices before import or sale.

  • Requires:

    • CE or FCC certifications as supporting evidence

    • Technical specifications and frequency details

    • Local representative or importer to file applications

• Labeling Requirements:

  • Labels must be in Arabic or English, and include:

    • Product name

    • Manufacturer/importer contact details

    • Country of origin

    • Instructions for use and safety warnings

    • Expiry or batch number (for health-related products)

    • Certification or approval number (if applicable)

• Import Oversight:

  • Importers must provide:

    • Invoice and packing list

    • Certificate of origin

    • CoC or recognized foreign certification

    • NMPB registration (if required)

    • Telecom type approval (if applicable)

    • Customs declaration

• Market Surveillance:

Conducted by SSMO, NMPB, TPRA, and Customs, focusing on health and safety compliance, labeling accuracy, and prevention of counterfeit goods. Non-compliant products may be confiscated, fined, or banned from sale.