Saudi Food and Drug Authority (SFDA) Approval Process

Before we talk about the Saudi Food and Drug Authority (SFDA), we will find that the Saudi Market is the Major and leading Market in the MENA region. Most overseas investments aspire to win a share of this thriving, vital market to win some distinguished profits out of this huge trade movement.

According to the aforementioned, the Kingdom of Saudi Arabia sets regulations and standards for the manufacturing, import, and distribution of food, drugs, and medical devices through the Saudi Food and Drug Authority (SFDA).

If you scroll down, you will learn more about the Saudi Food & Drug Authority (SFDA) Approval Process.

Saudi Food and Drug Authority (SFDA)

The Saudi Food and Drug Authority (SFDA), officially Saudi Food and Drug Authority or Saudi SFDA, is an independent regulatory body in Saudi Arabia established to protect public health by ensuring the safety, quality, effectiveness, and compliance of food, drugs, medical devices, cosmetics, and related products for both humans and animals.

SFDA meaning refers to this authority’s role as the Kingdom’s central regulator that sets mandatory standards, oversees registration and licensing, conducts monitoring and testing, and raises consumer awareness across regulated sectors. SFDA Saudi Arabia operates under a Council of Ministers resolution and reports directly to the President of the Council of Ministers, working to regulate products, whether locally manufactured or imported.

SFDA means not only enforcement of safety standards but also research, policy development, and collaboration with international scientific and legal agencies to safeguard public health and support informed decision-making across the supply chain.

What is the SFDA certificate?

An SFDA Certificate, often referred to as a Certificate of Conformity (CoC), is an official document issued under the authority of the Saudi Food and Drug Authority (SFDA) that confirms a product complies with the safety, quality, technical, and regulatory standards required by SFDA Saudi Arabia before it can be legally imported, marketed, or cleared through customs in the Kingdom.

It is part of the regulatory framework overseen by the Saudi Food and Drug Authority (sfda), the independent body responsible for ensuring the safety and effectiveness of food, drugs, medical devices, cosmetics, and other regulated products in the Saudi market.

This certificate demonstrates that a product has undergone the necessary conformity assessment, including documentation review, testing, and inspection where applicable, to meet SFDA requirements, which helps protect public health, facilitates customs clearance, and builds consumer confidence in products entering the Saudi market.

How to get SFDA approval?

How to get SFDA approval starts with understanding that SFDA approval is an official authorization issued by the Saudi Food & Drug Authority (SFDA) to confirm that a product complies with Saudi regulatory, safety, and quality requirements before it can be imported, sold, or distributed in the Kingdom.

The Saudi Food & Drug Authority regulates food, drugs, medical devices, cosmetics, and related products, and approval is granted only after a structured conformity and technical review process to protect public health in Saudi Arabia.

To explain clearly how to get SFDA approval, the main steps include:

1. Registering the company and product through the official SFDA electronic systems
2. Preparing complete technical documentation, including product details, ingredients, labeling, and specifications
3. Submitting test reports from accredited laboratories to demonstrate compliance with SFDA standards
4. Appointing a local Saudi representative if required by the Saudi Food & Drug Authority
5. Applying through the relevant SFDA platform (such as Ghad) for review and assessment
6. Responding to any SFDA queries or requests for clarification
7. Receiving final SFDA approval in the form of a conformity certificate or marketing authorization once all requirements are met

What is GHAD SFDA?

The GHAD platform is a unified electronic system developed by the Saudi Food and Drug Authority (SFDA) to streamline and modernize how regulated products are registered, licensed, and managed in SFDA Saudi Arabia.
It was launched as part of the SFDA’s digital transformation strategy to replace older systems and centralize regulatory services for products such as cosmetics, personal care, medical devices, food and other regulated goods across the Kingdom.

What it is:

Ghad SFDA is an online digital platform that functions as the official portal for product notification, registration, and regulatory compliance management with the Saudi Food and Drug Authority. It serves as the central entry point where companies create accounts, register their products, and maintain up-to-date regulatory information for market access.

What it is for:

The main purpose of the GHAD platform is to:

• Facilitate product registration and listing so only compliant products can be marketed or imported into Saudi Arabia.
• Enable licensing and regulatory oversight by the Saudi Food & Drug Authority.
• Support transparency and traceability of products in the Saudi market, ensuring that consumers and regulators can track product compliance.
• Replace older individual systems (eCosma, FRCS, etc.) with a single, standardized digital interface.

How it works:

Companies and local representatives create an account on the Ghad SFDA portal and then submit the required product information and documentation for review. Once submitted, the platform manages regulatory workflows such as data updates, classification, approvals, and notifications needed for compliance with SFDA regulations.

In many cases, GHAD is integrated with other systems (like the Faseh platform for import/export and conformity certificates) so that the entire regulatory journey from registration to customs clearance can be handled digitally.