SFDA Product Registration & Approval in Saudi Arabia

The Saudi Food and Drug Authority (SFDA) is responsible for ensuring that all products entering the Saudi market — including food, cosmetics, and medical devices — meet the required safety, health, and quality standards.

To import, distribute, or manufacture regulated products in Saudi Arabia, companies must complete a set of registration and approval procedures through SFDA’s official systems.

Below is a summary of the main steps involved in achieving full SFDA compliance:

1. Account Setup on SFDA Platforms

Before any product can be registered, companies are required to create and activate accounts on SFDA’s digital platforms.
This includes:

• Registering the company on SFDA systems (for importers, distributors, or manufacturers).

• Linking the company profile with Saudi Customs and other relevant authorities.

• Completing verification and activation to enable future product and shipment submissions.

This step establishes the foundation for all subsequent registration and clearance activities.

2. Product Listing & Registration

Once the company account is active, each product category must be registered under the appropriate SFDA system:

a. Cosmetics & Personal Care Products
Products must be registered in the SFDA Cosmetic Platform in compliance with Saudi regulations for ingredients, labeling, and packaging.
The process typically involves:

• Checking ingredients against SFDA’s restricted and prohibited substance lists.

• Translating and reviewing product labels for compliance.

• Submitting product data and following up until approval is issued.

b. Food & Beverage Products
Food products are registered through the Food Registration System (FRS).
Requirements include:

• Providing detailed product compositions and nutritional information.

• Uploading labels, images, and certificates of origin.

• Ensuring labeling and composition comply with SFDA standards prior to approval.

c. Medical Devices & Equipment
Medical devices must be registered under the Medical Device National Registry (MDNR) or GHAD system, depending on product classification and risk level.
Key steps include:

• Determining the correct risk class.

• Preparing and uploading technical documentation and conformity certificates.

• Coordinating with an authorized representative based in Saudi Arabia.

Once approved, the products become eligible for customs clearance and local distribution.

3. Shipment Registration on Fasah / Clearance Systems

After product approval, each shipment entering Saudi Arabia must be registered through SFDA’s electronic clearance systems, often integrated with the Fasah platform.
The process includes:

• Entering shipment data and linking it to approved product files.

• Submitting required documentation for review.

• Coordinating clearance with customs to prevent detention or rejection due to incomplete SFDA records.

Proper shipment registration ensures smooth and timely customs release.

4. Issuance of Shipment Conformity Certificates (CoC)

Certain regulated shipments require a Certificate of Conformity (CoC) issued by SFDA-approved conformity assessment bodies.
The steps usually involve:

• Selecting the appropriate accredited body based on the product type.

• Submitting supporting documents (invoices, packing lists, test reports).

• Receiving and uploading the certificate into SFDA systems before clearance.

This certificate verifies that the shipment meets Saudi technical, safety, and health standards, allowing entry into the local market.