Saudi Arabia FDA (SFDA) Authorized Representative (AR)

For foreign manufacturers without a physical legal entity in Saudi Arabia, it is mandatory to appoint a local legal entity as their Authorized Representative (AR) to register and sell products. This is mandatory to comply with Saudi Food & Drug Authority (SFDA) regulations.

There must also be a formal, documented agreement between the manufacturer and the AR, approved according to Saudi regulations. This agreement should specify:

• The activities the AR will perform on behalf of the manufacturer.
• The types or groups of medical devices covered.
• Post-market surveillance obligations the AR must fulfill.
• The duration and termination terms of the agreement.

While manufacturers can appoint distributors as ARs, it is often recommended to have an independent AR to avoid conflicts of interest and maintain control over product registrations and regulatory obligations.

Liaison with the SFDA

Your AR serves as your official point of contact with the SFDA. All regulatory communications are handled through the AR. This includes responding to authority questions, coordinating audits or inspections, and ensuring that any regulatory updates or requests are addressed promptly.

Registration

The AR is responsible for managing and submitting all medical device and IVD registration applications to the SFDA, including the coordination of the full registration lifecycle. The AR also tracks application progress and manages authority feedback.

Documentation

Your AR is responsible for preparing, reviewing, and submitting all required regulatory documentation in accordance with SFDA guidelines. This includes compiling submission dossiers, maintaining technical documentation and ensuring documentation aligns with Saudi regulatory requirements.

Compliance

Beyond initial approval, the AR ensures that all devices placed on the Saudi market remain compliant with applicable SFDA regulations and standards. This includes verifying labelling requirements and ensuring adherence to Saudi-specific regulatory frameworks. Labelling must be in Arabic and/or English with specific content requirements. The AR also oversees post-market compliance activities, such as vigilance reporting, complaint handling, and corrective actions when necessary.

MDMA submission

The AR is responsible for preparing and submitting the Medical device Marketing Authorization (MDMA) application. This process requires detailed technical documentation, evidence of safety and performance, and proof of compliance with applicable standards. The AR ensures that the MDMA dossier is complete, accurate, and aligned with SFDA expectations.