SFDA CERTIFICATION SERVICES

SFDA Certification - Overview

SFDA Certification is a compulsory regulatory license granted by the Saudi Food and Drug Authority on food, pharmaceuticals, medical equipment and cosmetic products. It makes sure that products comply with Saudi safety, quality, labeling standards, and standards of compliance before the entry into the market. Products which are not registered by SFDA cannot be imported or sold in Saudi Arabia.

Compliance with SFDA contributes to easy customs clearance, penalties, and development of regulatory trust in businesses. As an organization with skilled SFDA consultants to complete documentation, product licensing, and approvals, they can achieve success in the Saudi market even sooner and maintain the quality of the product and the continued compliance.

An SFDA Certificate is an official document issued by the Saudi Food and Drug Authority which affirms that a product is in compliance with the existing Saudi regulations and technical standards.

Any firm planning to promote food products, pharmaceuticals, cosmetics or medical devices in Saudi Arabia needs to seek approval through SFDA before it can be commercialized.

The certification confirms:

• Product safety and performance
• Ingredient and formulation compliance
• Labeling and packaging accuracy
• Manufacturing and quality control systems
• Product licensing and classification

The Saudi regulatory provisions prescribe SFDA certification as a means of ensuring the safety of the populace and consumers.

Without previous SFDA approval, it is impossible to import, sell or distribute products in Saudi Arabia. Some of the enforcement mechanisms that can be used to enforce regulations are shipment detention, recall of products, suspension of licenses, and fines that may be imposed as a result of non-conformance.

Products are also matched with international quality standards under the SFDA certification, which enhances the credibility as well as the confidence of the market and the regulatory bodies.

Registration of the SDFA happens to be compulsory to:

Whatever the type of business, SFDA certification is mandatory in legal business.

The following are the documents required for obtaining SFDA Certification:

In order to receive your desired Certificate of Conformity:

Market access requirements that will be offered at SFDA:

Below is a brief description of the SFDA drug registration and approval process:

A) Market Authorization Process

To legally market a drug in Saudi Arabia, manufacturers must obtain Marketing Authorization (MA) from the SFDA. This process is carried out in two main phases:

Phase 1: Application Submission

Phase 2: Review and Approval

B) Verification and Abridged Registration Procedures

Verification Procedure: This pathway applies to products already approved and marketed by both the USFDA and the European Medicines Agency (EMA), allowing for a faster review process.

Abridged Procedure: If a product is approved and marketed by either the USFDA or the EMA, it may qualify for the abridged registration process, reducing approval timelines.

C) Waiver of Onsite GMP Inspection

SFDA may waive the onsite GMP inspection if the manufacturing facility has already been approved under the Gulf Cooperation Council (GCC) Drug Registration system.

D) Importance of a Local Saudi Agent

Foreign pharmaceutical manufacturers must appoint an authorized local agent in Saudi Arabia. This local entity is essential for regulatory communication, application management, and ongoing coordination with the SFDA.

E) Importation of Non-Registered Drugs

SFDA permits the import of non-registered pharmaceutical products under special circumstances, such as:

• New or life-saving essential drugs
• Products with no available substitutes in the Saudi market

Before importation, the local agent must obtain a shipment-specific import permit from the SFDA.

The regulatory compliance and sustainability of businesses in Saudi Arabia requires SFDA certification for the following key reasons:

We render professional and end-to-end SFDA certification and registration services to companies across the world. Our professional SFDA consultants undertake the whole process of regulation effectively and properly.

Our comprehensive services include:

• Whole SFDA documentation preparation
• Product categorization and conformity regulations
• Compliance check of label and packaging
• SFDA system registration and submission
• Rapid response to queries and follow ups
• End-to-end product licensing services
• Renewal support and post-approval compliance

Our deep industry knowledge enables businesses to gain expedited approvals, eliminate the risk of rejection, and ensure complete compliance with the SFDA.

SFDA Certification is mandatory for any business planning to import, manufacture, or distribute regulated products in Saudi Arabia. It ensures compliance with Saudi regulations, prevents legal risks, and builds long-term market trust.

With expert SFDA consultants managing documentation, registration, and approvals, the certification process becomes smooth, accurate, and stress-free. Professional guidance ensures timely approvals and seamless entry into the Saudi market.