Agence sénégalaise de Réglementation pharmaceutique (ARP) current fee schedule, reviewed for 2026, in XOF.
13 fee lines100% exact amountscurrency XOFFX rates 2026-09-17reviewed 2026-09-16
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| Marketing authorisation — Class D device, registration (enregistrement) Section 6, row « Dispositif Médical de classe D »; the authorisation is valid five years and renewable (arrêté, art. 17). | XOF 1,000,000 | $1,754 | Per product | Verified |
| Marketing authorisation — Class D device, renewal (renouvellement) Renewal must be filed 120 days before expiry (arrêté, art. 21). | XOF 500,000 | $877 | Per product, every 5 years | Verified |
| Marketing authorisation — Class D device, major variation Décret n° 2023-2419, art. 20 makes any modification of the dossier subject to a variation request. | XOF 1,000,000 | $1,754 | Per variation | Verified |
| Marketing authorisation — Class D device, minor variation Section 6, « Variation mineure » row for class D. | XOF 250,000 | $438 | Per variation | Verified |
| Marketing authorisation — Class C device, registration (enregistrement) Section 6, row « Dispositif Médical de classe C ». | XOF 500,000 | $877 | Per product | Verified |
| Marketing authorisation — Class C device, renewal (renouvellement) The tariff's validity cell for the C and D rows reads « 05 ANS ». | XOF 250,000 | $438 | Per product, every 5 years | Verified |
| Marketing authorisation — Class C device, major variation Section 6, « Variation majeure » row for class C. | XOF 500,000 | $877 | Per variation | Verified |
| Marketing authorisation — Class C device, minor variation Section 6, « Variation mineure » row for class C. | XOF 250,000 | $438 | Per variation | Verified |
| Class A and class B devices — declaration (déclaration de dispositifs médicaux) The tariff's validity cell for this row reads « aucun délai » (no time limit). The tariff groups class A and class B under a declaration while the arrêté requires a marketing authorisation for class B (arts. 15-16); the two instruments are not reconciled here. | XOF 10,000 | $17.54 | Per product | Verified |
| Locally manufactured device — registration (cas des industries locales) Section 6 carries a separate schedule for « CAS DES INDUSTRIES LOCALES » with five-year validity. | XOF 500,000 | $877 | Per product | Verified |
| Locally manufactured device — renewal (cas des industries locales) Local-industry renewal is priced at the same amount as local-industry registration. | XOF 500,000 | $877 | Per product, every 5 years | Verified |
| Locally manufactured device — major variation (cas des industries locales) Section 6, local-industry schedule. | XOF 250,000 | $438 | Per variation | Verified |
| Locally manufactured device — minor variation (cas des industries locales) Section 6, local-industry schedule. | XOF 125,000 | $219 | Per variation | Verified |
Government fees only — service and testing costs are separate- Amounts are in CFA francs (XOF), which has no subunit; the tariff publishes whole francs.
- The schedule also prices a late renewal as a formula rather than an amount — « 1% du montant du renouvellement par jour de retard » for classes C and D — and publishes no numeric amount for it, so it is not stated here as a fee row.
- Radio-equipment agrément fees are charged separately by the ARTP under art. 70 of loi n° 2018-028: XOF 59,000 dossier fee and XOF 236,000 agrément fee per equipment, VAT included, per the ARTP procedure cited in the certification dataset.
- Décret n° 2023-2419, art. 39 makes a technical evaluation by a comité d'experts and a validation by a commission nationale part of homologation, but the schedule prices no separate expert-committee or commission fee.
- Class B, C and D marketing authorisations are issued by ARP decision and are valid five years; the class A and B declaration line carries no stated validity period.
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Exact amounts verified against the Agence sénégalaise de Réglementation pharmaceutique (ARP) fee schedule · full review 2026-09-16 · row IDs are stable — cite as government-fees:senegal:class-d-enregistrement