Côte d'Ivoire medical device registration timeline
Source-linked clocksAutorité Ivoirienne de Régulation Pharmaceutique (AIRP) review clocks and end-to-end planning ranges, using the 4-class (A, B, C, D) — IMDRF/WHO model adopted for the UEMOA member states by UEMOA Décision n° 03/2022/CM/UEMOA (annexe I-1), with a separate A/B/C/D DMDIV table (annexe I-2) classification system.
1 pathways1 of 1 clocks verifiedvalidity 5 years for an AIRP Autorisation de Commercialisation (renewable); ARSN enregistrement 5 years, ARSN agrément 2 years and ARSN licences 1 to 3 years according to the practice listed in art. 33 of décision n° 000010; the ARTCI homologation certificate publishes no validity periodMDSAP not acceptedreviewed 2026-09-16api.airpdigital.com
| Class / pathway | Review clock | Planning total | With prior approval | Provenance |
|---|---|---|---|---|
| ARSN authorisation, licence, enregistrement or agrément — a device or installation using ionizing radiation(Autorisation or agrément issued by the ARSN under loi n° 2013-701 du 10 octobre 2013 and décision n° 000010 ARSN/DG du 6 janvier 2026, after a mandatory inspection of the applicant's premises before the grant) Décision n° 000010 ARSN/DG du 6 janvier 2026, art. 18: "L'ARSN dispose d'un délai de quarante-cinq (45) jours calendaires à compter de la complétude du dossier pour accorder ou refuser une autorisation ou un agrément au demandeur." The clock runs from dossier completeness, not from deposit, and an inspection must be carried out before the grant (art. 17). | 45 days | 2-4 months | — | Verified |
Review clocks exclude applicant hold time · planning totals are estimatesPlanning steps and estimates; these are not regulator deadlines.
Côte d'Ivoire Medical Device Registration Process
Step-by-step AIRP registration process. Total estimated timeline: 2-4 months.
Step 1: Pre-Submission Preparation
1-3 monthsGather technical documentation, quality management system (QMS) records, and clinical data required by AIRP. Appoint a Importateur ou distributeur de dispositifs médicaux agréé par l'AIRP, mandaté par le fabricant (représentant du fabricant).
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to AIRP including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksAIRP reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
45 daysIn-depth technical assessment of device safety and performance. AIRP may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, AIRP issues Côte d'Ivoire market authorization certificate.
Summary: The Côte d'Ivoire medical device registration process through Autorité Ivoirienne de Régulation Pharmaceutique (AIRP) 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 the AIRP Autorisation de Commercialisation, but a certified copy of the attestation de conformité obtained through the international procedures recognised by the AIRP is a required item of the Ivorian dossier, so the CE technical file is reusable evidence.
WHO prequalificationNo unilateral reliance route for devices was read in the instruments cited here: the AIRP evaluates the dossier itself, and the UEMOA harmonisation leaves the device marketing authorisation with the national authority (Décision n° 03/2022/CM/UEMOA, art. 2).
Key requirements
- Every actor in the device supply chain must file a prior declaration ("listing des Dispositifs Médicaux") with the AIRP before introducing any device into Côte d'Ivoire, whatever its class, and the Autorisation de Commercialisation is granted only on an evaluation of conformity against the UEMOA essential requirements.
- The Autorisation de Commercialisation application is filed in four copies with the AIRP Director-General by an AIRP-agréé importation/commercialisation company mandated by the manufacturer, and must name the manufacturer, the applicant and the manufacturer's representative.
- The administrative dossier must include a certified copy of the attestation de conformité obtained through the international procedures recognised by the AIRP, any GMP certificate in force, a document attesting first marketing in the country of origin, a valid batch conformity certificate, the attestation de Prix Grossiste Hors Taxe in CFA francs with the price structure, and proof of payment of the homologation fees.
- The technical dossier (CD-ROM or DVD-ROM) must carry the stability studies where applicable, a lifecycle risk-management plan, a check-list demonstrating conformity with the essential requirements and the corresponding standards, a summary of the technical specifications in French, and the labelling and instructions-for-use models.
- Three samples of the final sales model must be supplied in French with at least twelve months of validity, with certificates of analysis; all documents must be in French, in a box or binder naming the product, the laboratory, the representation agency and a telephone contact.
- The Autorisation de Commercialisation is valid for five years and renewable, and the tariff prices registration, major and minor variations and renewal by class.
- A supplementary technical evaluation can be required on the expert committee's advice, with the evaluation fees fixed according to the protocol required and charged to the applicant.
- Any equipment to be connected to a public Telecommunications/ICT network, and any radioelectrical equipment, must be homologated by the ARTCI and hold its certificate before being connected; the test laboratories used must be accredited by the ARTCI, recognised under international agreements or otherwise authorised under Ivorian law.
- Any activity or practice involving exposure to ionizing radiation requires an ARSN authorisation (licence or enregistrement according to the 30 kV / source-category thresholds) or an ARSN agrément for the listed service activities, granted after an inspection, and the operator must designate a Personne Compétente en Radioprotection.
Primary regulator sources
api.airpdigital.com · AIRP, « Modalités d'homologation des dispositifs médicaux », N° 0970/AIRP, dated « Abidjan, le 26.05.2023 » — declaration/listing, the Autorisation de Commercialisation dossier and its five-year validity, the conformity check-list, and the persons authorised to apply website.arsn.ci · Décision n° 000010 ARSN/DG du 6 janvier 2026 modifiant la décision n° 000005 ARSN/DG du 3 mai 2021 portant conditions de délivrance, de renouvellement, de modification, de suspension, de retrait d'une autorisation, d'un agrément en matière de radioprotection, de sûreté et de sécurité nucléaires — arts. 3-8, 12-14, 16-19, 33-35 and 39 website.arsn.ci · ARSN — Autorisastion: definition of an authorisation, licence and enregistrement scopes, downloadable forms; Agrément: the service activities subject to agrément artci.ci · Ordonnance n° 2012-293 du 21 mars 2012 relative aux Télécommunications et aux Technologies de l'Information et de la Communication, titre VI, arts. 88-93 (Journal officiel du 14 août 2012) and the ARTCI homologation procedure page
Reviewed 2026-09-16. End-to-end totals remain planning estimates.
Keep researching this market
More Côte d'Ivoire medical device resources
Continue with this market
Source-linked review clocks verified against AIRP publications · full review 2026-09-16 · row IDs are stable — cite as registration-timeline:cote-divoire:arsn-authorisation-or-agrement