Rwanda FDA current fee schedule, reviewed for 2026, in USD.
4 fee lines100% exact amountscurrency USDFX rates 2026-09-17reviewed 2026-09-16
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| Registration and marketing authorisation of imported machinery, medical equipment and devices - to be imported from the EAC Part I item 2, row 'Machinery, medical equipment and devices', column 'To be imported from EAC'. The fee covers a five-year registration and includes a GMP inspection. | USD 100 | $100 | Per product, five-year registration | Verified |
| Registration and marketing authorisation of imported machinery, medical equipment and devices - to be imported from SRAs or WHO Listed Authorities Part I item 2, column 'To be imported SRAs, WLAs'. The differential is expressed by origin of import, so a device made in a non-SRA country but holding an SRA approval is not obviously inside this row on the face of the table. | USD 400 | $400 | Per product, five-year registration | Verified |
| Registration and marketing authorisation of imported machinery, medical equipment and devices - to be imported from other sources Part I item 2, column 'To be imported from other sources'. The five-year registration includes a GMP inspection. | USD 600 | $600 | Per product, five-year registration | Verified |
| Notification of the registration of machinery, medical equipment and devices Annex II item I.3 waives the fee for the notification of the registration of machinery, medical equipment and devices, applicable to both domestic and imported products. A verified zero, not a missing value. | USD 0 | $0 | Per notification | Verified |
- The registration fee is set by the origin of import and not by device class, so both published bands carry the same spread: USD 100 for East African Community origin, USD 400 for SRA or WHO Listed Authority origin and USD 600 for other sources. There is no cheaper or dearer class row in the tariff.
- Every published amount in this record is an exact figure printed in the schedule; the tariff contains no formula rows for these items.
- Renewal is charged at 100% of the initial fee (Part IV item 11) and a major variation at 50% of the initial fee (Part III item 10). Both are percentages of another fee rather than published amounts, so they are excluded from the details and not converted into figures.
- The importer and wholesaler licence fee of FRW 100,000 (Part VI item 14) is denominated in Rwandan francs inside an otherwise US-dollar tariff, so it is excluded from this USD record rather than converted.
- The instrument is signed on 31/12/2024 and Article 10 provides that the regulations come into force on the date of publication in the Official Gazette; the effectiveDate recorded here is the date of the instrument.
- The fee row for imported devices sits in Part I, which covers registration and marketing authorisation of imported regulated products for five years.
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Exact amounts verified against the Rwanda FDA fee schedule Β· full review 2026-09-16 Β· row IDs are stable β cite as government-fees:rwanda:registration-imported-eac-origin