Saudi Arabia Regulatory Approval Process for Medical Devices

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The Saudi FDA (SFDA) medical device approval process explained

Prior to being sold in the Kingdom of Saudi Arabia (KSA), medical devices must receive marketing authorization from the Saudi Food and Drug Authority (SFDA) under Interim Regulation (1-8-1429) issued on December 27, 2008.

Step 1

Your device must have prior market authorization in one of the following reference markets: Australia, Canada, European Union, Japan, or the USA. The device classification in your reference market will determine the classification of your device in the KSA.

Step 2
Appoint a KSA Authorized Representative (AR) to manage your device registration in Saudi Arabia. Your representative must be licensed with the Saudi Food and Drug Authority (SFDA) and you must have the contract legalized between you and your AR.

Step 3
Your AR must present the legalized AR contract to the SFDA for review and will obtain a License permitting them to represent you in the Saudi market. This license must be renewed each year and there is a fee.

Step 4
Prepare Medical Device Marketing Authorization (MDMA) application and submit through your Authorized Representative. The application includes device labeling, IFU, promotional materials, proof of regulatory approval in your reference market and quality system certification (if applicable). Labeling, promotional materials and IFU must be in English and Arabic. English-only is acceptable for professional use devices. Pay application fee.

Step 5
The MDMA application is reviewed for completeness by the SFDA, then passed to a third-party Conformity Assessment Body (CAB) for technical review. The technical review is rigorous and detailed. Multiple rounds of qu estions are not uncommon.

Step 6
The SFDA makes the final decision based on recommendations of the CAB. Once the device is approved, the SFDA issues an MDMA certificate and you may begin marketing your device in Saudi Arabia.

Step 7
Class I device registrations are valid for three years. Device registrations for the other classes are valid for the remaining term of validity in the reference country you have chosen (if there is an explicit expiration date), or three years if the regulatory approval is open ended (example: FDA 510(k) clearance).


Chart updated: 03/06/2016