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SFDA Registration & Certification

Navigate Saudi Arabia's food and drug regulatory landscape with expert support. We manage your complete SFDA registration journey for food products, pharmaceuticals, medical devices, and cosmetics.

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Why Choose SANTIQ

Regulatory Expertise

Specialists in all SFDA product categories and platforms

Fast Processing

Streamlined submissions with complete documentation

Multi-Platform Experience

Ghad, FRCS, eCosma, MDMA — we handle them all

End-to-End Support

From initial registration to renewals and compliance

Understanding SFDA

What is SFDA Registration?

The Saudi Food and Drug Authority (SFDA) is the independent regulatory body responsible for ensuring the safety, quality, and efficacy of food, pharmaceuticals, medical devices, cosmetics, and health-related products in Saudi Arabia.

SFDA registration is mandatory for all regulated products before they can be legally imported, manufactured, distributed, or sold in the Kingdom. Without proper SFDA approval, products cannot clear customs or enter the market.

Why SFDA Registration Matters

  • Legal requirement for market access
  • Ensures consumer safety and product compliance
  • Enables customs clearance for imports
  • Builds market credibility and consumer trust

SFDA Electronic Platforms

Ghad System

Multi-category platform for establishment and product registration

FRCS

Food Registration & Clearance System for food products

eCosma

Facility notification and product listing for cosmetics

MDMA

Medical Device Market Authorization platform

Product Categories

SFDA-Regulated Product Categories

Comprehensive registration services across all SFDA product sectors

Cosmetics

Fast notification-based registration via eCosma platform.

  • • Personal care products
  • • Skincare & makeup
  • • Hair care products
  • • Perfumes & fragrances

Food & Feed

Compliance with Saudi and GCC food safety standards via FRCS.

  • • Packaged foods
  • • Supplements & nutraceuticals
  • • Beverages
  • • Animal feed

Pharmaceuticals

Rigorous dossier review with full technical and clinical data.

  • • Prescription drugs
  • • OTC medications
  • • Biologics
  • • Vaccines

Medical Devices

Risk-based classification and market authorization via MDMA.

  • • Diagnostic equipment
  • • Surgical instruments
  • • Monitoring devices
  • • Implantable devices
Registration Process

Your SFDA Registration Journey

A clear, managed process from application to approval

1

Pre-Registration Assessment

We review your products and identify regulatory requirements, timelines, and documentation needs.

  • • Product classification and category determination
  • • Identification of applicable SFDA regulations
  • • Gap analysis of existing documentation
  • • Timeline and cost estimation
2

Establishment Registration

Create accounts and register your facility on the relevant SFDA platforms.

  • • Electronic account creation on SFDA portals
  • • Commercial registration and business activity verification
  • • Establishment license application (if required)
  • • Local representative appointment for foreign companies
3

Documentation Preparation

Compile and prepare all required technical, safety, and compliance documentation.

Common Requirements

  • • Product formulation and specifications
  • • Arabic and English labels
  • • Certificate of Free Sale
  • • Manufacturing certifications (GMP, ISO)

Product-Specific

  • • Clinical data (pharmaceuticals)
  • • Technical files (medical devices)
  • • Safety data sheets (cosmetics)
  • • Test reports and compliance evidence
4

Application Submission

Submit complete product registration applications through the appropriate SFDA platform.

  • • Portal-specific application forms completed
  • • All supporting documentation uploaded
  • • Application fees paid
  • • Acknowledgment and tracking number received

Review, Approval & Renewals

SFDA reviews your application and issues certification. We manage ongoing renewals to maintain authorization.

  • • SFDA technical review and assessment
  • • Response to queries or requests for clarification
  • • Certificate issuance and market authorization
  • • Renewal management (typically 1-3 year validity)
FAQ

Frequently asked questions

Common questions about SFDA registration and certification

Who needs SFDA registration?

Any company wishing to import, manufacture, distribute, or sell food, pharmaceuticals, cosmetics, or medical devices in Saudi Arabia must obtain SFDA registration before market entry.

How long does SFDA registration take?

Timelines vary by product type. Cosmetics can be registered in days with complete documentation. Food products vary by complexity. Pharmaceuticals and medical devices typically take weeks to months depending on the review requirements.

Do I need a Saudi company?

Yes, you need a Saudi-licensed local entity or must appoint an authorized Saudi representative. Foreign companies without a Saudi presence cannot register products directly.

What is the cost of SFDA registration?

Costs depend on product type, complexity, and whether additional testing or documentation preparation is needed. Contact us for a detailed quote based on your specific products.

How often do I need to renew?

SFDA certificates typically have validity periods of 1-3 years depending on product category. Renewals are mandatory before expiry to maintain market authorization and avoid disruption.

Can I use international certifications?

International certifications (CE, FDA, ISO) can support your application and may streamline the review process, but SFDA registration is still mandatory for the Saudi market.

Ready to Register with SFDA?

Our SFDA specialists will guide you through the entire registration process, ensuring compliance and successful market entry.

  • Complete regulatory assessment
  • Multi-platform submission support
  • Renewal and compliance management
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What You'll Get

Free Consultation

Expert review of your products and requirements

Detailed Quote

Transparent pricing with no hidden fees

Implementation Roadmap

Clear timeline and next steps