The Saudi Food and Drug Authority (SFDA) and Saudi Standards, Metrology, and Quality Organization (SASO) oversee the process with distinct regulations. As part of Vision 2030, Saudi Arabia launched the SABER program to streamline product registration. Here’s all you need to know to get started!

Overview of SABER Program

The SABER Program, led by SASO, streamlines product registration in Saudi Arabia, ensuring only standards-compliant products enter the market to uphold safety and quality.

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SASO Registration Process in Saudi Arabia

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Product Classification

Identify the relevant SASO regulations for your product type and prepare necessary documentation such as product specifications, technical details, and safety data sheets.

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Pre-registration Requirements

For certain products, obtain a Certificate of Conformity (CoC) from an accredited inspection body. Ensure the product complies with SASO’s technical standards.

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Product Testing and Inspection

Submit the product for testing at authorized laboratories to meet SASO standards. Some products may undergo physical inspection to confirm compliance with safety and quality criteria.

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Submit Registration Application

Register through the Saudi Product Safety Program (SALEEM) online portal. Required documents include commercial registration, product details, CoC (if applicable), and inspection reports.

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Payment of Fees

Pay the relevant fees based on the product and testing requirements.

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SASO Review and Approval

SASO will assess the application, documents, and test results. If compliant, SASO issues a registration certificate; if issues arise, revisions may be requested.

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Issuance of SASO Certificate

Upon approval, the product is registered and eligible for sale in Saudi Arabia. Products must display the SASO Quality Mark or required certification marks.

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Ongoing Compliance

SASO may conduct market inspections to ensure continued compliance. Some registrations require periodic renewal and re-submission of documentation.

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Categories of Products to Be Registered in Saudi Arabia

Consumer-Oriented Products

  • Food and Beverages: Packaged food, bottled water, dietary supplements, and infant formula (overseen by SFDA).
  • Pharmaceuticals and Healthcare Products: Prescription medications, OTC drugs, and medical supplements (governed by SFDA).
  • Medical Devices and Equipment: Diagnostic equipment, surgical instruments, and dental tools (managed by SFDA).
  • Cosmetics and Personal Care Products: Makeup, skincare, perfumes, and hair care items (supervised by SFDA via the Ghad system).
  • Toys and Children’s Products: Toys, baby products, and safety gear (monitored by SASO and GCC).
  • Tobacco and Nicotine Products: Cigarettes, vapes, and chewing tobacco (administered by SFDA).

Industrial and Specialized Products

  • Industrial Products: Machinery, appliances, and construction materials (overseen by SASO).
  • Electronic Devices: Phones, laptops, and home appliances (governed by SASO and GCC).
  • Chemical Products: Fertilizers, pesticides, and chemicals (managed by MEWA and SFDA).
  • Automotive Parts: Vehicles, tires, and batteries (monitored by SASO and ZATCA).
  • Packaging Materials: Food-grade bottles and plastic containers (controlled by SFDA).
  • Energy Products: Solar panels and HVAC systems (administered by SASO and MEWA).

SABER Categories for Individuals, Importers, and Local Factories

  • Applies to: Individuals registering products for personal use or resale.
  • Requirements:
  • Individuals must submit proof of commercial registration if applicable.
  • Products need to comply with relevant Saudi technical standards.
  • Applies to: Businesses importing products for distribution in Saudi Arabia.
  • Requirements:
    • Importers must provide a Certificate of Conformity (CoC) for each product.
    • Products must comply with the relevant SASO technical standards and undergo testing if required.
    • The registration process is done via the SALEEM platform, which is a part of the SABER system.
  • Applies to: Local manufacturers of products intended for the Saudi market.
  • Requirements:
    • Manufacturers must register their products before they can be sold in the market.
    • They must meet Saudi standards and submit required documentation, such as factory certifications and product specifications.
    • The registration process includes ensuring compliance with local and international standards.

Regulatory Authorities for Product Registration in Saudi Arabia

Saudi Food and Drug Authority (SFDA):

  • Regulates food, pharmaceuticals, medical devices, cosmetics, and herbal products.
  • Manages online systems like FRCS (Food), SDR (Drugs), and Ghad (Cosmetics) for product registration.
  • Evaluates safety, efficacy, and conformity of products to approved standards.

Saudi Standards, Metrology, and Quality Organization (SASO):

  • Develops and enforces technical standards and regulations for various products.
  • Operates the SABER platform to issue conformity certificates (PCoC and SCoC) required for imports and sales in Saudi Arabia.

Zakat, Tax, and Customs Authority (ZATCA):

  • Ensures that all imported products comply with registration and certification requirements.
  • Verifies the presence of the Shipment Certificate of Conformity (SCoC) before customs clearance.

Gulf Cooperation Council (GCC) Standardization Organization:

  • Works collaboratively with SASO for regional technical standards.
  • Governs the Gulf conformity mark (G-Mark) for regulated products like electronics and toys.

Comparison of SFDA and SASO Registration Processes

Aspect SFDA SASO
Scope Food, drugs, medical devices General products, industrial goods
Key Systems FRCS (Food), SDR (Drugs), Ghad (Cosmetics) SABER, SALEEM
Certification Issued Product safety and efficacy certificates Certificate of Conformity (CoC)
Regulation Focus Safety, efficacy, and labeling Quality, technical standards
Regulated Products Food, beverages, pharmaceuticals, medical devices, cosmetics Electronics, toys, textiles, machinery, automotive parts, and more
Documentation Needed Product specifications, safety certificates, manufacturing licenses Technical details, CoC, factory certifications
Approval Process Involves SFDA review, lab testing, and database registration Testing via accredited bodies
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How Riz & Mona Consultancy Can Help?

Riz & Mona Consultancy is renowned as one of the top business setup consultants in Dubai, with over 15 years of experience facilitating a wide range of businesses throughout the UAE. Our deep connections with government officials and key authorities, combined with our extensive expertise in consultancy, streamline the process of establishing your business in Dubai. Additionally, we offer comprehensive financial, legal, and corporate services to support our clients throughout their business endeavors.

We are here to provide comprehensive support for your SFDA Registrations in Saudi, from preparing your documents to completing the process. Connect with us now to begin your journey with a FREE consultation!

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FAQS (Frequently Asked Questions)

Which authorities are responsible for approving goods in Saudi Arabia?

Two key organizations handle product authorization: one oversees product safety and importation about health-related items like food and pharma, while the other manages general goods like electronics and textiles.

How can I identify the correct authority for my product?

Determine whether your product is health-related (e.g., food, drugs, or beauty products) or a general item (e.g., electronics, toys, or building materials). The relevant authority depends on the product classification.

What is the process for registering a product?

The process involves creating an account on a designated platform, submitting detailed product information and documentation, undergoing conformity assessments, and obtaining the required certificates.

What certifications are required for product authorization?

Products must have a Conformity Certificate to confirm compliance with Saudi standards. For imports, a Shipment Certificate is also mandatory.

Are there specific platforms for registration?

Yes, different platforms cater to different types of products. For example, one platform manages health-related goods, while another handles general products like electronics and machinery.

What documents do I need for registration?

Required documents include product specifications, safety and compliance certificates, manufacturer details, and proper labeling in Arabic and English.

How does the process differ for imports and locally manufactured goods?

Imported goods require shipment-specific certification, while local products need compliance validation and registration under national standards.

How can I ensure my goods meet regulatory standards?

Choose an approved assessment body to evaluate product compliance and ensure all technical documentation aligns with Saudi regulations.

What are the consequences of non-compliance?

Non-compliant products can face penalties, shipment rejections, or delays in customs clearance.

How do I list non-regulated products?

For non-regulated items, self-declarations can be submitted to confirm compliance, bypassing full certification.

What is the role of the SABER platform in the product listing?

This platform streamlines the process for listing general products, issuing conformity certifications, and managing imports.

Can individuals import personal-use items without going through the full process?

Yes, specific provisions simplify the process for personal items like household goods or vehicles.

Do regulations apply equally to all types of goods?

Regulations vary based on the category of goods, with stricter protocols for consumable and health-related items.

Are periodic renewals required for food registration?

Yes, some certifications require periodic updates to maintain compliance, especially for health-related products.

How can businesses reduce the time and cost of product-approval?

Work with an experienced consultant or a locally approved assessment body to ensure documentation is accurate and meets all requirements.