Saudi Arabia enforces a highly developed product compliance system based on mandatory technical regulations, extensive use of the SASO Quality Mark, and strong import controls. It is a member of the Gulf Cooperation Council (GCC) and participates in the GSO (Gulf Standardization Organization). Compliance focuses on consumer safety, health regulations, and market surveillance, using both national and regional standards.

Key Authorities:

• Saudi Standards, Metrology, and Quality Organization (SASO) – Develops Saudi Technical Regulations, manages certification schemes, and oversees market surveillance.

• Saudi Food and Drug Authority (SFDA) – Regulates pharmaceuticals, medical devices, food products, and cosmetics.

• Communications, Space and Technology Commission (CST) – Manages telecom and RF device regulation, including type approval and licensing.

• Zakat, Tax and Customs Authority (ZATCA) – Enforces import documentation and regulatory compliance at borders.

Key Compliance Elements:

• SABER Platform and SASO Certification:

  • All regulated products must be registered in the SABER platform before import.

  • Certification options include:

    • Product Certificate of Conformity (PCoC) – Issued per product category.

    • Shipment Certificate of Conformity (SCoC) – Required for each import shipment.

  • Some categories (e.g., electrical appliances, children’s products) must also carry the SASO Quality Mark or G-Mark (for GCC-regulated items).

• Product Registration (SFDA):

  • Mandatory for:

    • Pharmaceuticals and vaccines

    • Medical devices and diagnostics

    • Food supplements and cosmetics

  • Registration involves:

    • Submission through SFDA portals (eCosma, Ghad)

    • Clinical and safety data

    • Certificates like GMP or ISO 13485

    • Local authorized representative (Authorized Representative Program)

• Telecom Type Approval (CST):

  • All RF and telecom devices must obtain CST type approval before import or sale.

  • Requires:

    • CE/FCC test reports as supporting evidence

    • Technical documents and frequency compliance

    • Registration through CST’s online platform

  • Approved devices must carry a CST approval label.

• Labeling Requirements:

  • Labels must be in Arabic or bilingual (Arabic and English) and include:

    • Product name

    • Manufacturer/importer details

    • Country of origin

    • Usage instructions and warnings

    • Expiry/batch number (for health and food products)

    • SASO Quality Mark, G-Mark, or CST type approval number (if applicable)

• Import Oversight:

  • Importers must submit:

    • Registration in SABER

    • Product and Shipment CoC

    • SFDA registration certificates (if applicable)

    • CST type approval certificate (for telecom devices)

    • Invoice, packing list, and certificate of origin

    • Customs declaration through FASAH platform

• Market Surveillance:

  • Conducted by SASO, SFDA, CST, and ZATCA, focusing on regulated products in markets, warehouses, and entry points. Non-compliant products may face fines, recalls, or import bans.