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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

National Provisions and Requirements for Medical Devicesen SA-00109/2014
The Interim Regulatory Schemeen 1-8-1429 12/2008

Specific Guidance Documents

Barcode FAQen FAQ08/2015
Guidance for Local Manufacturers en MDS - G204/2009
Guidance for Medical Device Authorised Representativesen MDS - G304/2009
Guidance for Medical Devices Importers and Distributors en MDS - G104/2009
Guidance for Overseas Manufacturers en MDS - G404/2009
Guidance on Marketing Authorization Proceduresen MDS - G504/2009
Guidance on Medical Devices Bundling/Grouping Criteria en MDS - G704/2009
Guidance on Post-Marketing Surveilance en MDS - G604/2009
Implementing Rule On Licensing Of Authorised Representatives en MDS - IR5 v302/2011
Implementing Rule On Marketing Authorisationen MDS – IR 6 v304/2009
Implementing Rule On Post- Marketing Surveillance en MDS – IR 7 v101/2010
Implementing Rule on Designation and Oversight of Conformity Assessment Bodiesen MDS - IR1 v201/2010
Implementing Rule on Establishment Licensing en MDS - IR4 v402/2011
Implementing Rule on Establishment Registration en MDS - IR2 v304/2010
Implementing Rule on Medical Devices Listing en MDS - IR3 v404/2010
Implementing Rule on Safeguard Procedures en MDS-IR801/2010

Forms and Applications

Marketing Authorization Application formen for use with MDS IR601/2010

Additional Information

Authorised Representative application fees and review times en MDS - AN00512/2010
Establishment licensing application fees and review times en MDS - AN00612/2010
Marketing Authorization application fees and review times en 2/13/MDS-AN01209/2014