Saudi Arabia Medical Device Regulations

All documents listed below were published by Saudi Food and Drug Authority (SFDA) and are in PDF format.

Based on the Council of Ministers resolution no. (181) issued on 18/6/2007, that gave SFDA the right to issue regulations for medical devices registration rules and procedures, the SFDA issued a medical devices interim regulation, which was adopted by SFDA board of director’s decision no. (1-8-1429) issued on 27/12/2008. This regulation will apply until the medical devices comprehensive law is approved.

Major Regulations


Document	Language	Number	Published
National Provisions and Requirements for Medical Devices	en	SA-001	09/2014
The Interim Regulatory Scheme	en	1-8-1429	12/2008

Specific Guidance Documents


Document	Language	Number	Published
Barcode FAQ	en	FAQ	08/2015
Guidance for Local Manufacturers	en	MDS - G2	04/2009
Guidance for Medical Device Authorised Representatives	en	MDS - G3	04/2009
Guidance for Medical Devices Importers and Distributors	en	MDS - G1	04/2009
Guidance for Overseas Manufacturers	en	MDS - G4	04/2009
Guidance on Marketing Authorization Procedures	en	MDS - G5	04/2009
Guidance on Medical Devices Bundling/Grouping Criteria	en	MDS - G7	04/2009
Guidance on Post-Marketing Surveilance	en	MDS - G6	04/2009
Implementing Rule On Licensing Of Authorised Representatives	en	MDS - IR5 v3	02/2011
Implementing Rule On Marketing Authorisation	en	MDS – IR 6 v3	04/2009
Implementing Rule On Post- Marketing Surveillance	en	MDS – IR 7 v1	01/2010
Implementing Rule on Designation and Oversight of Conformity Assessment Bodies	en	MDS - IR1 v2	01/2010
Implementing Rule on Establishment Licensing	en	MDS - IR4 v4	02/2011
Implementing Rule on Establishment Registration	en	MDS - IR2 v3	04/2010
Implementing Rule on Medical Devices Listing	en	MDS - IR3 v4	04/2010
Implementing Rule on Safeguard Procedures	en	MDS-IR8	01/2010

Forms and Applications


Document	Language	Number	Published
Marketing Authorization Application form	en	for use with MDS IR6	01/2010

Additional Information


Document	Language	Number	Published
Authorised Representative application fees and review times	en	MDS - AN005	12/2010
Establishment licensing application fees and review times	en	MDS - AN006	12/2010
Marketing Authorization application fees and review times	en	2/13/MDS-AN012	09/2014