To apply for Class C medical device registration with the Saudi Food and Drug Authority (SFDA) in Saudi Arabia, you will use the GHAD system, which is SFDA’s official online platform for medical device applications.

Steps to Apply for Class C Medical Device Registration in Saudi Arabia:

1. Appoint a Saudi Authorized Representative (AR)

   • Non-Saudi manufacturers must appoint a Saudi-based Authorized Representative (AR), who is licensed by the SFDA. This AR will handle the submission process on your behalf.

2. Register with the SFDA GHAD Portal

   • Both the manufacturer and the Authorized Representative need to register on the GHAD portal (SFDA’s e-service platform). The GHAD system is used to submit, track, and manage the application for medical device marketing authorization.

   GHAD Portal:

   • SFDA GHAD System Link

   • You will need to create an account and ensure all information about the manufacturer, the product, and the AR is complete and accurate.

3. Submit the Application for Medical Device Marketing Authorization (MDMA)

   • Once registered on GHAD, you or your AR can begin the process of submitting the Medical Device Marketing Authorization (MDMA) application.
   • This involves uploading all the required documentation, including the technical file, risk management file, clinical data, labeling, and ISO 13485 certification.
   • The application is submitted electronically via the GHAD portal, and all documentation must comply with SFDA guidelines.

4. Pay Application Fees

   • After submitting the MDMA application, you will need to pay the application fees through the GHAD system. These fees cover the SFDA’s review and evaluation of your device.

5. Track the Application

   • Once submitted, the GHAD system allows you to track the status of your application, respond to SFDA queries, and provide any additional information requested by the SFDA.

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