What are SFDA Registration Requirements?

Understanding SFDA Registration Requirements is a critical step for any company planning to place food, drug, medical, cosmetic, or health-related products on the Saudi market. The Saudi Food and Drug Authority plays a central role in protecting public health by regulating products before and after they enter the market. Complying with SFDA Registration Requirements ensures legal market access, product safety, and consumer trust in Saudi Arabia.

Who Needs SFDA Saudi Arabia Registration?

SFDA Saudi Arabia registration is mandatory for any entity involved in manufacturing, importing, or distributing regulated products within the Kingdom. This includes:

• Local manufacturers operating inside Saudi Arabia
• Importers bringing products into the Saudi market
• Authorized representatives of foreign manufacturers
• Distributors and marketing authorization holders

Any company dealing with food, pharmaceuticals, medical devices, cosmetics, dietary supplements, or related products must comply with Saudi Food and Drug Authority (SFDA) regulations to legally operate in the Kingdom.

SFDA Registration Saudi Arabia Requirements

SFDA registration requirements vary depending on the product category, but they generally fall into two main areas: company registration and product registration.

Here is the SFDA Guideline for the SFDA Registration Requirements:

Company Registration Requirements

Before submitting any product for SFDA registration, the company itself must be registered with the Saudi Food and Drug Authority. Key requirements include:

• A valid Commercial Registration (CR) issued in Saudi Arabia
• A valid Saudi national address
• Registration on SFDA electronic platforms (such as GHAD or MDMA, depending on product type)
• Appointment of an authorized person responsible for regulatory communication
• Compliance with SFDA guidelines and SFDA regulations

Once approved, the company is assigned an SFDA code, which is essential for all future product submissions.

Product Registration Requirements

After company registration, each product must be registered individually according to SFDA requirements. Product registration typically includes:

• Complete product formulation and specifications
• Labeling and artwork compliant with SFDA guidelines
• Safety and technical documentation
• Certificates of analysis or free sale certificates, when required
• Product classification according to SFDA meaning and scope

For food products, SFDA food registration requires additional nutritional data, ingredient compliance, and shelf-life documentation to meet Saudi food and drug authority standards.

SFDA Registration Process in Saudi Arabia

The SFDA registration Saudi Arabia process follows a structured digital workflow designed to ensure transparency and traceability. The process generally includes:

1. Company account creation on the SFDA system
2. Submission of company registration documents
3. Obtaining the SFDA code
4. Product data entry and document upload
5. SFDA technical review and evaluation
6. Requests for clarification or corrections (if any)
7. Final acceptance or rejection

The Saudi Food and Drug Authority (SFDA) may take several weeks to review submissions, depending on product type and documentation quality.

How to Get SFDA Approval

Many businesses ask how to get SFDA approval and whether it is the same as registration. SFDA approval usually refers to the authority’s final acceptance after reviewing submitted data.

To obtain SFDA approval successfully, companies should:

• Ensure full compliance with SFDA guidelines
• Submit accurate and complete documentation
• Use correct product classification under SFDA regulations
• Respond promptly to SFDA inquiries

Failure to meet SFDA requirements can lead to delays, rejection, or additional compliance costs.

Difference Between SFDA Registration and SFDA Approval

Although often used interchangeably, SFDA registration and SFDA approval are not exactly the same.

SFDA registration refers to the formal process of listing a company or product in the SFDA Saudi Arabia system.
SFDA approval refers to the authority’s confirmation that the submitted product or activity complies with SFDA regulations and can be marketed legally.

In some cases, a product may be registered but still pending final SFDA approval before commercial distribution.

How Tabseer Supports SFDA Registration in Saudi Arabia

Navigating SFDA registration requirements can be complex, especially for foreign manufacturers or first-time applicants. Tabseer provides end-to-end regulatory support to simplify SFDA Saudi Arabia registration.

Tabseer’s services include:

1. Company and product eligibility assessment
2. Preparation and review of SFDA registration documents
3. Submission through official SFDA platforms
4. Compliance with Saudi food and drug authority guidelines
5. Follow-up with SFDA until registration or approval is completed

With deep expertise in SFDA regulations and local market requirements, Tabseer helps businesses reduce delays, avoid errors, and achieve faster market access in Saudi Arabia.

Learn more about SFDA registration requirements here:  https://tabseer.co/en/what-are-sfda-registration-requirements/

FAQs

How to register in SFDA?

To register in SFDA, a company must create an account on the SFDA system, submit required company and product documents, and comply with all SFDA regulations until approval is granted.

What is the meaning of SFDA Registration?

SFDA registration means officially listing a company or product with the Saudi Food and Drug Authority to allow its legal circulation in the Saudi market.

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