Staying compliant with the Saudi Food and Drug Authority (SFDA) is crucial for maintaining uninterrupted market access for medical devices in Saudi Arabia. One of the key regulatory requirements is ensuring timely renewal of the Authorized Representative (AR) license along with understanding the applicable SFDA fee for medical device representation.

This guide outlines the SFDA AR license renewal process, the applicable fees, and important timelines to help manufacturers and their representatives stay aligned with Saudi regulatory expectations.

What is an SFDA Authorized Representative License?

An Authorized Representative (AR) is a legal entity based in Saudi Arabia that represents foreign medical device manufacturers before the SFDA. The SFDA AR license is mandatory for registering and marketing medical devices in the Kingdom. Like initial registration, this license must be renewed periodically.

SFDA AR License Renewal Fee for Medical Devices (Official Statement)

“The renewal fee for a Saudi AR license renewal fees for medical devices is typically SAR 10,000 per year. This fee is fixed regardless of the type or number of devices the AR represents. Before applying for an AR license, companies should obtain a registration with the Saudi Food and Drug Authority (SFDA).”

Overview of SFDA AR License Fees for Medical Devices

• Annual AR License Renewal Fee: SAR 10,000
  (This is a flat rate for all ARs, regardless of product type or volume.)
• Other Associated Fees:
  • Minor changes (e.g., manufacturer name or address): SAR 5,000
  • Major changes (e.g., change in notified body or legal manufacturer): May trigger full registration fee
  • Marketing authorization applications: Fees vary depending on the risk class of the medical device (Class A–D)

Prerequisites Before AR License Renewal

Before renewing the AR license, the following must be in place:

• SFDA Establishment Registration Number
• Valid Commercial Registration (CR)
• Signed AR Agreement between the manufacturer and the Authorized Representative
• Updated QMS certificates (e.g., ISO 13485) if applicable

All documents must be uploaded through the SFDA’s GHAD system

Saudi AR License Renewal Process (2025)

The AR license renewal process in Saudi Arabia involves the following key steps:

Step 1: Login to the Ghad System

Access the SFDA’s Ghad portal using your existing company account.

Step 2: Submit Renewal Application

Select the Authorized Representative license and choose the renewal option.

Step 3: Upload Required Documents

Commonly requested documents include:

• Valid Saudi Commercial Registration
• Updated AR agreement with the foreign manufacturer
• Previous AR license certificate
• Quality Management System (QMS) or ISO 13485 (if applicable)

Step 4: Pay the SFDA Renewal Fees

The AR license renewal cost in Saudi Arabia varies depending on company type and scope.

Step 5: SFDA Review and Approval

The SFDA may request additional clarification or documents. Once approved, a new AR license certificate is issued.

When Should You Renew Your AR License in Saudi Arabia?

The SFDA AR license renewal should be initiated well before the license expiry date, typically 3 months in advance. Delays can lead to lapses in compliance, impacting your market access in Saudi Arabia.

Consequences of Missing the Renewal Deadline

Failure to renew the AR license on time can lead to:

• Suspension of current device registrations
• Delays in new product approvals
• Risk of losing legal representation in Saudi Arabia

In some cases, companies may need to restart the entire registration process, including payment of full fees.

Simplify Your Saudi AR License Renewal with OMC Medical

Renewing your SFDA AR license doesn’t have to be stressful. At OMC Medical, we make the process smooth — from reviewing your documents to submitting everything via the GHAD system.

We also support you with:

• Medical Devices & IVDs Regulatory Compliance
• Product Registration and Classification
• Authorized Representative Services
• ISO 13485 & QMS Setup
• Technical Documentation & Post-Market Support

Whether you’re an established manufacturer or a startup, our team is here to help you stay compliant and market-ready in Saudi Arabia.