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SFDA Services in
Saudi Arabia

Mandatory product registration and licensing for Food, Drugs, Medical Devices, and Cosmetics. Complete regulatory compliance support.

Check Product Compliance

Accessing the Saudi market with consumables or medical products requires strict approval from the Saudi Food and Drug Authority (SFDA). The Authority enforces rigorous safety standards to protect public health. No product in regulated categories enters the Kingdom without proceeding through the centralized SFDA registration portal.

Role of SFDA

The SFDA regulates, oversees, and controls food, drugs, medical devices, and cosmetics, as well as biological and chemical substances. It sets mandatory specifications for imported and locally manufactured products.

Ghadeer & E-Cosma: SFDA utilizes advanced electronic systems (like GHAD for medical devices and E-Cosma for cosmetics) for tracking products from port of entry to final sale.

Core Registration Services

We manage the end-to-end registration process for all product categories.

  • 🩺
    Medical Devices (MDMA) Obtaining Medical Device Marketing Authorization for importers and manufacturers.
  • 💄
    Cosmetics Notification Listing cosmetic products on the E-Cosma system for clearance.
  • 🍎
    Food Product Registration Approval of food items and verifying label compliance with GSO standards.
  • 🏭
    Establishment Licensing Licensing warehouses and factories to store or produce regulated products.

Registration Workflow

Typically involves technical file review and labeling checks.

1
Classification Determining the risk class of the product (Class I, II, or III) to set registration requirements.
2
Documentation Compiling Technical Files, Certificates of Free Sale, and ISO 13485 certifications.
3
Submission Uploading data to the GHAD or E-Cosma portal and paying authority fees.
4
Approval Receiving the Registration Certificate, enabling shipment and customs clearance.

Regulated Sectors

  • Pharmaceuticals & Herbal Products
  • Medical Devices & IVDs
  • Food & Supplements

Key Compliance Areas

SFDA has zero tolerance for non-compliance elements:

Authorized Rep

Foreign manufacturers must appoint a licensed Authorized Representative (AR) in regulations.

Labeling

Packaging and instruction manuals must be in Arabic (or English/Arabic) as per GSO.

Halal

Strict Halal certification is mandatory for any food/meat products entering the Kingdom.

Market Advantages

  • Access to Tender Only SFDA-registered medical products can be supplied to government hospitals (NUPCO tenders).
  • Customs Speed Registered products pass through port customs quickly via digital linkage.
  • Consumer Trust The SFDA mark ensures consumers that the product is safe and high quality.

Frequently Asked Questions

Yes, if you don't have your own entity in Saudi Arabia, you must appoint a local Authorized Representative (AR) who holds the license to represent your products.
Timelines vary by risk class. Low risk (Class I) can take 2-4 weeks, while high risk (Class III) or novel technologies may take 3-6 months for technical review.
SFDA gov fees vary significantly. Cosmetic notifications are relatively inexpensive, while Class III medical device fees can range from 18,000 to 230,000 SAR depending on certification routes.
Yes, having approval from reference countries (like US FDA, EU CE, Health Canada) significantly accelerates the SFDA approval process (Tsch-A route).

Register Your Products Today

Avoid customs hold-ups. Let our regulatory experts manage your SFDA profile.

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