Get In Touch:

Saudi Arabia

Medical Device Registration 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 

Documents Required:          

  • Application Form
  • Authorized Representative
  • MDNR Listing
  • Technical File
  • Conformity Assessment Report
  • Medical Device Market Authorization Certificate

Post-market surveillance:  

Adverse events to be reported to the SFA

Applicable QMS:          

ISO 13485

Registration Timeline:         

Class A – 1 month

Class B – 2-6 months

Class C – 4-8 months

Class D – 6-12 months

Authorized Representative:          

Yes

License Validity:          

3 years

Want to know more about this registration process?