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Saudi Arabia Medical Device Registration Fees
SFDA government fees for 2025
SAR 15,000
Low Risk Min
SAR 23,000
High Risk Max
SFDA
Authority
2025-12-16
Last Updated
Complete Fee Breakdown
| 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 |
Important Notes
- •Fees increase by risk class
- •UDI registration required
- •Custom pricing for >500 UDIs
- •SFDA accepts CE/FDA for expedited review
Frequently Asked Questions
Government fees are subject to change. Last data update: 2025-12-16. Always verify current fees with SFDA.