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

Medical Devices Interim Regulationen 4/16/143912/2017
National Provisions and Requirements for Medical Devicesen SA-00110/2018

Specific Guidance Documents

Barcode FAQen FAQ08/2015
Guidance for Local Manufacturers en MDS - G201/2013
Guidance for Medical Device Authorised Representativesen MDS - G301/2013
Guidance for Medical Devices Importers and Distributors en MDS - G101/2013
Guidance for Overseas Manufacturers en MDS - G401/2013
Guidance on Marketing Authorization Proceduresen MDS - G501/2013
Guidance on Medical Devices Bundling/Grouping Criteria en MDS - G706/2018
Guidance on Post-Marketing Surveilance en MDS - G604/2009
Implementing Rule On Licensing Of Authorized Representatives en MDS - IR5 v407/2018
Implementing Rule On Marketing Authorizationen MDS – IR 6 v407/2018
Implementing Rule On Post-Marketing Surveillance en MDS – IR 7 v207/2018
Implementing Rule on Designation and Oversight of Conformity Assessment Bodiesen MDS - IR1 v201/2010
Implementing Rule on Establishment Licensing en MDS - IR4 v507/2018
Implementing Rule on Establishment Registration en MDS - IR2 v407/2018
Implementing Rule on Medical Devices Listing en MDS - IR3 v507/2018
Implementing Rule on Safeguard Procedures en MDS-IR8 v207/2018

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-AN01203/2019