Saudi Arabia Medical Device Regulations

All documents listed below were published by Saudi Food and Drug Authority (SFDA) and are in PDF format. Please help us maintain this list by reporting outdated or missing documents to marketing [at] emergogroup [dot] com. If you need help determining the regulatory requirements for your medical device in Saudi Arabia, you may be interested in our custom regulatory strategy reports for Saudi Arabia.

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

• The Interim Regulatory Scheme
• National Provisions and Requirements for Medical Devices

Specific Guidance Documents

• Implementing Rule on Designation and Oversight of Conformity Assessment Bodies - MDS - IR1 version 2
• Implementing Rule on Establishment Registration - MDS - IR2 version 3
• Implementing Rule on Medical Devices Listing - MDS - IR3 version 4
• Implementing Rule on Establishment Licensing - MDS - IR4 version 4
• Implementing Rule On Licensing Of Authorised Representatives - MDS - IR5 version 3
• Implementing Rule On The Validation Of Documents - MDS - IR6 version 3
• Implementing Rule On Post- Marketing Surveillance - MDS - IR 7 version 1
• Implementing Rule on Safeguard Procedures - MDS-IR8

General Guidance Documents

• Guidance for Medical Devices Importers and Distributers - MDS - G1
• Guidance for Local Manufacturers - MDS - G2
• Guidance for Medical Device Authorised Representatives - MDS - G3
• Guidance for Overseas Manufacturers - MDS - G4
• Guidance on Marketing Authorization Procedures - MDS - G5

Forms and Applications

• Marketing Authorization Application form - MDS – IR 6

Additional Information

• Marketing Authorization application fees and review times - MDS - AN003
• Authorised Representative application fees and review times - MDS - AN005
• Establishment licensing application fees and review times - MDS - AN006