Saudi Arabia Regulatory Approval Process for Medical Devices
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The chart shown illustrates the Saudi Arabia approval process and is available for download in PDF format. However, if you would like to explain the steps to someone else in an email, you can cut and paste the text below or send them a link to this page.
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 the Medical Devices Interim Regulation (MDIR), Decree No. 1-8-1429/2008.
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.*
Appoint a Saudi Authorized Representative (AR) to manage your device registration in the KSA. Your representative must be licensed with the SFDA. Further, the SFDA must authorize the contract between you and your AR.
Your Saudi AR must present the authenticated AR contract to the SFDA for review and obtain a license to represent you in the KSA. The AR contract and license may be valid for 1-10 years; however, the AR license cannot be valid longer than the contract.
Prepare the Medical Device Marketing Authorization (MDMA) application and submit through your AR. 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.
The SFDA reviews the MDMA application for completeness. Then a third-party Conformity Assessment Body (CAB) performs a detailed technical review upon payment of the application fee.**
The SFDA makes the final decision based on recommendations of the CAB. Once the device is approved, the SFDA issues an MDMA certificate that you may provide to your distributor/importer for market entry.
Device registrations are valid for three years, or the remaining validity in the reference country you have chosen (if less than three years).
* For Class I non-sterile/non-measuring devices, manufacturer has the option to register devices through Medical Device National Registry (MDNR) via distributor/importer. The MDNR route
does not require an AR.
** The CAB technical review is very detailed; prepare to respond to multiple rounds of questions from the CAB.
Chart updated: 07/2019