Q: Are Saudi Arabia medical device fees annual or one-time?

Fee structure: Per application. See the full breakdown for details on each fee category.

Question 1

How much does Saudi Arabia medical device registration cost?

Accepted Answer

Saudi Arabia (SFDA) medical device registration fees range from SAR 15,000 to $18 depending on device class. Fees increase by risk class

Question 2

What fees does SFDA charge for medical devices?

Accepted Answer

Application Assessment - Class A: SAR 15,000. Application Assessment - Class B: SAR 19,000. Application Assessment - Class C: SAR 21,000. Application Assessment - Class D: SAR 23,000. UDI Code Fee (<150 codes): $15. UDI Code Fee (<500 codes): $18.

Question 3

Are Saudi Arabia medical device fees annual or one-time?

Accepted Answer

Fee structure: Per application. See the full breakdown for details on each fee category.

Fee Item	Amount	Frequency
Application Assessment - Class A	SAR 15,000	Per application
Application Assessment - Class B	SAR 19,000	Per application
Application Assessment - Class C	SAR 21,000	Per application
Application Assessment - Class D	SAR 23,000	Per application
UDI Code Fee (<150 codes)	$15	Per batch
UDI Code Fee (<500 codes)	$18	Per batch

Saudi Arabia Medical Device Registration Fees

How much does Saudi Arabia medical device registration cost?

Are these one-time or annual fees?

What other costs should I budget for?