Senegal medical device registration timeline
Source-linked clocksAgence sénégalaise de Réglementation pharmaceutique (ARP) (Agence sénégalaise de Réglementation pharmaceutique (ARP)) review clocks and end-to-end planning ranges, using the 4-class (A, B, C, D) — IMDRF/WHO model adopted nationally by décret n° 2023-2419, with a separate A/B/C/D table for IVDs classification system.
2 pathways2 of 2 clocks verifiedvalidity 5 years for a class B, C or D marketing authorisation (renewable); the class A and B declaration line in the tariff carries no stated validityMDSAP not acceptedreviewed 2026-09-16arp.sn
| Class / pathway | Review clock | Planning total | With prior approval | Provenance |
|---|---|---|---|---|
| Establishment agrément — manufacture, import, registration, export, distribution and maintenance of medical devices(Agrément d'établissement decided by the ARP Director-General (décret n° 2023-2419, art. 28; arrêté, arts. 2-14), after a prior inspection for manufacturing and wholesale-import establishments) Arrêté, art. 29: « L'Agence sénégalaise de Réglementation pharmaceutique statue sur toute demande d'agrément dans un délai de trois (03) mois à compter de la réception d'un dossier complet. Lorsque le dossier est déclaré incomplet, elle notifie au demandeur, dans un délai de deux (02) jours ouvrables, les pièces manquantes. Le délai d'instruction est alors suspendu jusqu'à réception des pièces requises. » | 3 months | 4-6 months | — | Verified |
| ARSN authorisation — device or installation using ionizing radiation(Autorisation issued by the ARSN under loi n° 2021-44 du 31 décembre 2021, with separate application forms for importation, exportation, détention et utilisation, and transport) ARSN, « Combien de temps prend le traitement d'une demande ? »: « Le délai de traitement varie selon le type d'autorisation, généralement entre 15 et 30 jours après réception d'un dossier complet. » The range is published for authorisations generally, not for a device class, so it is carried as a route-wide clock. | 15-30 days | 30-60 days | — | Verified |
Review clocks exclude applicant hold time · planning totals are estimatesPlanning steps and estimates; these are not regulator deadlines.
Senegal Medical Device Registration Process
Step-by-step Agence sénégalaise de Réglementation pharmaceutique (ARP) registration process. Total estimated timeline: 4-6 months.
Step 1: Pre-Submission Preparation
1-3 monthsGather technical documentation, quality management system (QMS) records, and clinical data required by Agence sénégalaise de Réglementation pharmaceutique (ARP). Appoint a Représentant local (mandated by the manufacturer).
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to Agence sénégalaise de Réglementation pharmaceutique (ARP) including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksAgence sénégalaise de Réglementation pharmaceutique (ARP) reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
3 monthsIn-depth technical assessment of device safety and performance. Agence sénégalaise de Réglementation pharmaceutique (ARP) may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, Agence sénégalaise de Réglementation pharmaceutique (ARP) issues Senegal market authorization certificate.
Summary: The Senegal medical device registration process through Agence sénégalaise de Réglementation pharmaceutique (ARP) (Agence sénégalaise de Réglementation pharmaceutique (ARP)) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.
Prior approval recognition
EU CE marking / notified-body certificateNot a substitute for ARP registration, but the technical file, the déclaration de conformité and the test reports behind a CE certificate are the same evidence the ARP requires for the enregistrement dossier.
WHO prequalificationNo reliance route is published: the ARP assesses the dossier itself, and the UEMOA harmonisation leaves the marketing authorisation with the national authority (Décision n° 03/2022/CM/UEMOA, art. 2).
Key requirements
- Importation of any medical device, whatever its class, needs a prior ARP authorisation (décret n° 2023-2419, art. 36; arrêté, art. 25).
- A class B, C or D device needs a marketing authorisation issued by ARP decision and valid five years, renewable; a class A device is filed as a declaration on the basis of a conformity assessment (arrêté, arts. 15-17).
- The marketing-authorisation dossier is deposited by the applicant through its local representative (arrêté, art. 18), so a foreign manufacturer needs a Senegal-based representative.
- Renewal must be filed 120 days before the authorisation expires (arrêté, art. 21).
- Technical documentation, identification and instructions must be established in the official national language, French (décret, art. 34).
- A certificat de mise en service is issued by the ARP before any first use of a high-risk device, in particular classes C and D (décret, art. 40).
- The ARP fixes the national list of devices subject to homologation and it must contain at least classes B, C and D (décret, art. 38).
- Radioelectrical equipment needs a prior ARTP agrément before use on Senegalese territory (loi n° 2018-028, art. 70); the ARTP procedure publishes dossier requirements and fees but no review period.
- A device using ionizing radiation needs an ARSN authorisation held by the operator, for which the ARSN publishes generally 15-30 days after a complete dossier.
Primary regulator sources
arp.sn · Décret n° 2023-2419 du 27 décembre 2023 fixant les conditions de fabrication, d'importation, d'enregistrement, d'exportation et de distribution des dispositifs médicaux, Journal officiel n° 7704 du 24 février 2024, arts. 34, 36, 38, 39 and 40 arp.sn · Arrêté du Ministre de la Santé et de l'Hygiène publique pris en application de l'article 28 du décret n° 2023-2419, fixant les modalités d'octroi d'agrément pour les établissements de fabrication, d'importation, d'enregistrement, d'exportation, de distribution et de maintenance des dispositifs médicaux — arts. 15-21, 25 and 29 (registered 22 May 2026) artp.sn · ARTP procédure d'agrément d'équipement radioélectrique — requirements under art. 70 of loi n° 2018-028 du 12 décembre 2018 portant Code des Communications électroniques arsn.sn · ARSN, « Combien de temps prend le traitement d'une demande ? » — published treatment time, validity and renewal of a radioprotection authorisation
Reviewed 2026-09-16. End-to-end totals remain planning estimates.
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Source-linked review clocks verified against Agence sénégalaise de Réglementation pharmaceutique (ARP) publications · full review 2026-09-16 · row IDs are stable — cite as registration-timeline:senegal:arp-establishment-agrement