Registration requirements with the Saudi Food and Drug Authority (SFDA) vary depending on the product category, including food, cosmetics, pharmaceuticals, and medical devices. However, all registrations generally follow a standardized process through the SFDA’s “Ghad” platform. Typical requirements include:

• Company Information
• Product Information
• List of Ingredients / Components
• Certificate of Conformity or Analysis
• Product Label

The success of a registration application largely depends on the quality and completeness of the regulatory dossier, where all technical and regulatory requirements are carefully prepared and reviewed to ensure full compliance with SFDA requirements.

Our team focuses on professionally preparing and validating regulatory files to minimize errors and maximize the likelihood of approval from the first submission without delays or regulatory observations.

Yes. Our experts provide on-site consultation for warehouse preparation, implementation of Good Storage Practice (GSP) standards, and ensuring full compliance with storage, distribution, and safety requirements mandated by regulatory authorities.

We provide ongoing post-registration support, including monitoring license and certification validity before expiration. We also offer pharmacovigilance and regulatory monitoring services to track reports, complaints, and potential product side effects.

Yes. To engage with the SFDA and manage regulatory licensing processes, foreign companies are generally required to appoint an Authorized Representative (AR) within Saudi Arabia.

The registration process typically takes between 30 and 90 days, depending on the completeness of the regulatory file and the responsiveness to regulatory observations and inquiries.

Registration costs vary depending on the product category and regulatory requirements. Therefore, we provide a tailored quotation after reviewing the regulatory file and project scope.

Yes. We support businesses by connecting them with distributors, facilitating market access, and assisting in securing their first commercial opportunities within the Saudi market.

The Medical Device Marketing Authorization (MDMA) certificate is an official regulatory approval issued by the Saudi Food and Drug Authority (SFDA). It authorizes medical devices to be legally marketed, sold, and distributed within the Saudi market.

Registration applications are not usually rejected due to procedural complexity alone, but rather due to the quality and completeness of the regulatory file from the outset. Common reasons for rejection include incomplete or inaccurate technical documentation, errors in ingredient or product data, non-compliant product labeling, or the use of unauthorized claims that do not meet SFDA requirements.

Our team proactively addresses these factors during dossier preparation to maximize approval potential and minimize the risk of regulatory observations or rejection.

The “Ghad” platform is an electronic system operated by the Saudi Food and Drug Authority (SFDA) to manage product registration procedures and regulatory follow-up within Saudi Arabia.

Through the platform, users can:

•  Register products (food, cosmetics, pharmaceuticals, and medical devices)
•  Submit applications and upload regulatory documents
•  Track application status and regulatory updates

Non-compliance with SFDA regulations may result in application rejection or regulatory observations requiring corrective action. To minimize these risks, we conduct a thorough pre-assessment of the product and regulatory file to identify and address any compliance gaps before submission.