Product Registration in Saudi Arabia

In Saudi Arabia, product registration is a mandatory process aimed at protecting consumers and ensuring that all products entering the market comply with strict health, safety, and quality regulations. The Saudi Food and Drug Authority (SFDA) is the primary regulatory body responsible for assessing product compliance, conducting safety evaluations, and maintaining records to verify adherence to national standards.

Once a product meets all regulatory requirements, the SFDA issues a Product Registration Certificate, granting approval for legal distribution within the Kingdom. It is important to note that registration is required for all products before they can be sold or distributed in Saudi Arabia, including those imported exclusively for re-export purposes.

Why is Product Registration Mandatory in Saudi Arabia?

Product registration is a critical requirement in Saudi Arabia, as all products intended for local trade must be registered with the relevant regulatory authorities. A Product Registration Certificate is mandatory and must be presented during the customs clearance process for imported goods.

This registration ensures that all consumer products display accurate and complete labeling, providing customers with the necessary information about the products they are purchasing. Such transparency allows consumers to make informed decisions and strengthens overall trust in the market.

Additionally, product registration is essential for consumer safety, as it involves a comprehensive review of the product’s ingredients. Regulatory authorities evaluate whether any substances may pose health risks and identify restricted or harmful ingredients. Products containing such ingredients may either be rejected or require modifications before receiving approval. This regulatory framework helps maintain high safety standards, ensuring that only compliant and safe products are available in the Saudi Arabian market.

The following documents are generally required for registering a food product in the Kingdom of Saudi Arabia (KSA). However, it’s important to note that the exact documentation requirements may vary depending on the product type and specific regulations. The accurate documents will be determined upon actual submission for product registration with the Saudi Food and Drug Authority (SFDA).

To successfully register a food product in KSA, businesses must submit the following documents to the SFDA:

  • Commercial Registration Certificate: A valid certificate of the importing company.
  • Certificate of Free Sale (CFS): Proof that the product is legally sold in its country of origin.
  • Good Manufacturing Practice (GMP) Certificate: Indicates that the manufacturing facility complies with international quality standards.
  • Product Specification Sheet: Detailed information on ingredients, nutritional facts, and shelf life.
  • Safety and Efficacy Studies (if applicable): Documentation supporting the product’s safety and effectiveness.
  • Product Label in Arabic and English: Labels must include product name, ingredients, origin, expiration date, storage instructions, and usage directions, complying with SFDA labeling requirements.
  • Packaging Artwork with Mandatory Labeling Requirements: Ensures packaging meets SFDA standards, including clear and accurate labeling.
  • Laboratory Test Reports: Analytical reports verifying the product’s compliance with safety and quality standards.
  • Manufacturer’s Authorization Letter: A letter from the manufacturer authorizing the importer to register and distribute the product in KSA.
  • Halal Certification: Certifies that the product complies with Islamic dietary laws, which is essential in Saudi Arabia.
  • Importer’s Declaration of Conformity: A statement from the importer affirming that the product meets all applicable standards and regulations.

Ensuring all these documents are prepared and submitted accurately is crucial for a smooth registration process with the SFDA.

The following steps outline the general process for registering a product in Saudi Arabia. Exact steps and requirements may vary depending on the product type and regulatory authority.

  1. Company Registration – Businesses must register with the Saudi Food and Drug Authority (SFDA) through the GHAD system.
  2. Product Classification – The product is classified under the relevant category (e.g., food, cosmetics, health supplements) to determine the applicable regulations and requirements.
  3. Document Submission – Submit all required documents to the SFDA for review and approval.
  4. Laboratory Testing – Some products may require additional laboratory testing to ensure compliance with safety and quality standards.
  5. Regulatory Approval – Once the product meets all requirements, the SFDA grants the product Registration Certificate, allowing for legal distribution within the Kingdom.

This structured process ensures that products meet regulatory standards for market entry and consumer safety in Saudi Arabia.

Product registration in Saudi Arabia is regulated by various authorities depending on the product type. The Saudi Food and Drug Authority (SFDA) oversees pharmaceuticals, medical devices, cosmetics, and food products, while the Saudi Standards, Metrology, and Quality Organization (SASO) ensures compliance for industrial and consumer goods through the SABER system. The Ministry of Commerce (MOC) manages general consumer product safety, and MEWA (Ministry of Environment, Water & Agriculture) regulates agricultural and veterinary products. Other key entities include ZATCA for excise goods, SEEC for energy efficiency, and CST for telecom equipment. Each authority ensures products meet national safety, health, and quality standards before entering the market.

1. Saudi Food and Drug Authority (SFDA)

  • Applicable Products:
    • Pharmaceuticals
    • Medical devices
    • Cosmetics
    • Food products
    • Health supplements
    • Veterinary products
  • Department:
    • Drug Sector (for pharmaceuticals & health supplements)
    • Medical Devices Sector
    • Food Sector
    • Veterinary & Animal Feed Sector
  • Portal: SFDA Website
  • Certification:
    • Drug Registration Certificate (for pharmaceuticals)
    • Medical Device Marketing Authorization (MDMA)
    • Product Registration via GHAD System (for medical devices)
    • Cosmetics Product Notification (CPNP)

2. Ministry of Commerce (MOC)

  • Applicable Products:
    • General consumer products
    • Commercial goods
  • Department: Product Safety Department
  • Portal: MOC Website
  • Certification: Commercial Product Registration

3. Saudi Standards, Metrology, and Quality Organization (SASO)

  • Applicable Products:
    • Electrical appliances
    • Industrial products
    • Toys
    • Textiles
    • Construction materials
    • Cosmetics & perfumes
  • Department: Conformity & Certification Department
  • Portal: SASO Website
  • Certification:
    • SABER Certification (mandatory for product imports)
    • SALEEM Conformity Program

4. Ministry of Environment, Water & Agriculture (MEWA)

  • Applicable Products:
    • Agricultural products (pesticides, fertilizers, soil amendments)
    • Veterinary medicines
    • Animal feed
  • Department: Agriculture & Livestock Sector
  • Portal: MEWA Website
  • Certification:
    • Agricultural Product Registration
    • Veterinary Product Approval

5. Zakat, Tax, and Customs Authority (ZATCA)

  • Applicable Products:
    • Excise goods (tobacco, soft drinks, energy drinks, sweetened beverages)
  • Department: Excise Tax Division
  • Portal: ZATCA Website
  • Certification: Excise Goods Registration

6. Saudi Energy Efficiency Center (SEEC)

  • Applicable Products:
    • Electrical appliances
    • Vehicles
    • Industrial equipment
    • Energy-consuming products
  • Department: Energy Efficiency Standards Division
  • Portal: SEEC Website
  • Certification: Energy Efficiency Labeling

7. Communications, Space & Technology Commission (CST, formerly CITC)

  • Applicable Products:
    • Telecommunications equipment
    • IT products
    • Wireless devices
  • Department: Technical Standards Department
  • Portal: CST Website
  • Certification: Type Approval Certification

8. Saudi Arabian Monetary Authority (SAMA)

  • Applicable Products:
    • Financial services & fintech products
  • Department: Fintech & Digital Licensing Department
  • Portal: SAMA Website
  • Certification: Fintech Licensing

9. Saudi Civil Defense (for hazardous goods)

  • Applicable Products:
    • Fire safety equipment
    • Hazardous materials
  • Department: Fire Protection & Safety Division
  • Portal: Saudi Civil Defense Website
  • Certification: Civil Defense Product Approval
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