Saudi Arabia Medical Device Regulations

Log into RAMS to download the documents listed below along with more regulations and guidances for Saudi Arabia.

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Major Regulations
Document Number Published Language
Log in Medical Devices Interim Regulation 4/16/1439 12/2017 English
Specific Guidance Documents
Document Number Published Language
Log in SFDA Recognized Standards MDS-G44 2019 English
Log in Guidance on Innovative Medical Devices MDS-G43 English
Log in Guidance on Requirements for Reporting of Incident and Adverse Event of Medical Devices MDS-G39 2019 English
Log in Guidance on Requirements for Electronic Instructions for Use (e-IFU) of Medical Devices MDS-G41 2019 English
Log in Guidance on Medical Devices Classification MDS-G42 2019 English
Log in Guidance on Requirements of Shipments Clearance at Ports of Entry MDS-G21 2018 English
Log in Guidance on Labeling Requirements for Medical Device MDS-G10 2015 English
Log in Guidance on Medical Devices Grouping MDS-G7 2018 English
Log in Guidance on Requirements of Medical Devices Quality Management System for Distributors, Importers and Authorized Representatives MDS-G45 2020 English
Log in Guidance on Requirements for Medical Device Listing and Marketing Authorization MDS - G5 2019 English