Elevation Fees of Medical Device Marketing Authorization (MDMA) New Applications (Based on Risk Classification for Medical Devices) Fee Group Risk Classification Lead Time Elevation Fee FG (1) Class A 35 - 60 15,000 SAR FG (2) Class B Working Days 19,000 SAR (Based on Product FG (3) Class C type, risk classification 21,000 SAR FG (4) Class D and number of products 23,000 SAR included within the application) Update and Renew Applications Type of Change Request Fee Type Elevation Fee Renew Reduced 5,000 SAR Add device(s) Add model(s) Change brand name Update technical file of device(s) Transition period letter Minor change in manufacturer name/address Update label(s) only Administrative 1,100 SAR Update IFU(s) only Update advertising materials only Change risk classification Full Full fee according to risk classification Change legal manufacturer name/address For inquiries, please contact the Registration Support Team at MD.RS@sfda.gov.sa Restricted - مقيد
