Saudi Arabia Medical Device Regulations

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

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

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