EFDA current fee schedule, reviewed for 2026, in ETB.
5 fee lines100% exact amountscurrency ETBFX rates 2026-09-17reviewed 2026-09-16
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| New application screening Table 6 item 1. Payable before submitting the dossier or in parallel with the application submission. | ETB 350 | $2.16 | Per application | Verified |
| New application evaluation Table 6 item 2. Payable before submitting the dossier or in parallel with the application submission. | ETB 1300 | $8.03 | Per application | Verified |
| Renewal application evaluation Table 6 item 4. | ETB 870 | $5.37 | Per renewal application | Verified |
| Major variation application evaluation Table 6 item 5. EFDA administers post-approval changes under EFDA/GDL/098. | ETB 870 | $5.37 | Per variation application | Verified |
| Minor variation application evaluation Table 6 item 6. | ETB 650 | $4.01 | Per variation application | Verified |
Government fees only — service and testing costs are separate- Table 6 of EFDA/GDL/046 reproduces the rates and states they are payable 'as per the Rate of Service Fees issued by Council of Minister Regulation No. 370/2015'.
- The tariff is flat across risk classes: screening and evaluation cost the same for a Class I and a Class IV device or for a Class A and a Class D IVD, so the low-risk and high-risk bands carry the same published total of 350 + 1300 birr.
- Two rows of Table 6 are denominated in US dollars - laboratory test at 200 US dollars and agency agreement at 50 US dollars - and are excluded here rather than converted, because this record publishes the birr tariff only.
- EFDA/GDL/046 Version 005 was approved on 05.06.2026 and its effective date is recorded in the document history as 25.06.2026.
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Exact amounts verified against the EFDA fee schedule · full review 2026-09-16 · row IDs are stable — cite as government-fees:ethiopia:new-application-screening