Saudi Arabia

Ministry of Health:     

Ministry of Health

Regulatory Authority:          

Saudi Food & Drug Authority (SFDA)

Medical Device Regulation:          

Medical Devices Interim Regulation

Official Language:      

Arabic

Classification:    

Class A, B, C & D

Registration Process:

• Determine the device classification
• Appoint an Authorized Representative
• Prepare the application form and required documentation.
• Submit the information for registration purposes
• Provide the medical device listing information to the Medical Device National Registry (MDNR)
• Submit Medical Device Marketing Authorization (MDMA)
• Once approved, the device can be marketed