Saudi Arabia (SFDA) Medical Device Regulations

Overview of Saudi Arabia (SFDA) medical device regulations

Prior to selling in the Kingdom of Saudi Arabia (KSA), manufacturers must obtain marketing authorization from the Saudi Food and Drug Authority (SFDA) for their medical and in vitro diagnostic (IVD) devices. All classes of medical devices require pre-market approval prior to market entry. 

Saudi Arabian medical device regulatory process

The chart illustrates the SFDA approval process per device classification in the KSA and is available for download in the Regulatory Affairs Management Suite (RAMS). Only a condensed overview of the main steps for registration is provided here. 

Step 1 
Determine the classification of your device according to the SFDA’s classification rules. 

Step 2 
Appoint a KSA Authorized Representative (AR) to manage your device registration and interact with the SFDA on your behalf. Your KSA AR must present the authenticated AR contract to the SFDA for review and obtain a license to represent you in the KSA. 

Step 3 
Prepare the Technical File and application form for submission to the SFDA.  

Step 4 
Pay the application fee. The SFDA reviews the application and may request additional information. 

Step 5 
Upon SFDA approval, you will be issued a Medical Device Marketing Authorization (MDMA) certificate for your device.