SFDA current fee schedule, reviewed for 2026, in SAR.
13 fee lines100% exact amountscurrency SARFX rates 2026-09-24reviewed 2026-08-25
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| Application Assessment - Class A | SAR 15,000 | $4,000 | Per application | Verified |
| Application Assessment - Class B | SAR 19,000 | $5,067 | Per application | Verified |
| Application Assessment - Class C | SAR 21,000 | $5,600 | Per application | Verified |
| Application Assessment - Class D | SAR 23,000 | $6,133 | Per application | Verified |
| Establishment licence - medical-device manufacturer | SAR 5,000 | $1,333 | Per 5-year licence | Verified |
| Establishment licence - authorised representative | SAR 2,600 | $693 | Per year (1–10 years, per contract) | Verified |
| Establishment licence - distributor/importer Class A | SAR 25,000 | $6,667 | Per year | Verified |
| Establishment licence - distributor/importer Class B | SAR 15,000 | $4,000 | Per year | Verified |
| Establishment licence - distributor/importer Class C | SAR 8,000 | $2,133 | Per year | Verified |
| Establishment licence - distributor/importer Class D | SAR 5,000 | $1,333 | Per year | Verified |
| Establishment licence - warehouse | SAR 800 | $213 | Per year (1–5 years; SAR 800 each additional year) | Verified |
| Advertising approval - directed to lay persons | SAR 3,000 | $800 | Per approval | Verified |
| Advertising approval - directed to health practitioners | SAR 6,000 | $1,600 | Per approval | Verified |
Government fees only — service and testing costs are separate- SFDA marketing-authorization assessment fee by risk class (fee circular effective 28 February 2016, still linked by the current SFDA FAQ).
- Establishment-licence periods and fees follow MDS-REQ9 v2.0 Annex 2; upgrading to a higher class costs the fee difference.
- Advertising approvals follow MDS-REQ8 v4.0 (20 July 2026).
- UDI, testing, and commercial service costs are excluded.
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Exact amounts verified against the SFDA fee schedule · full review 2026-08-25 · row IDs are stable — cite as government-fees:saudi-arabia:application-assessment-class-a