Product approval
A certificate or approval attached to the finished product, component, or radio host.
Free · No signup · Official source linksCôte d'Ivoire medical device certification and licence checker
Check Côte d'Ivoire requirements beyond medical-device classification, including radio, electrical, metrology, radiation, import, environmental, and product-specific routes.
6 maintained routes10 official source links
Preliminary applicability · country-specific scope
What you receive
Not just a yes or no
A route-by-route answer. Separate product certificates, dossier evidence, import documents, and facility licences stay separate.
Trigger reasoning. See which product facts matter and which missing facts prevent a reliable conclusion.
Official starting points. Open the regulator or government sources behind the maintained country matrix.
How to read the answer
Classification is only the first layer
A device may have one medical risk class and still trigger separate radio, electrical, measurement, radiation, environmental, import, or installation requirements. The checker keeps each regulatory object separate.
Dossier or import evidence
Testing can belong inside the medical dossier, while some documents apply to each shipment.
Site or operator licence
Radiation, installation, use, or measurement controls may apply to a facility or operator.
Country-specific scope
Medical device certification routes in Côte d'Ivoire
EMC
AIRP conformity assessment — electromagnetic compatibility
Evidence is normally handled inside the medical-device registration route.
Source association reviewed
Electrical safety
AIRP conformity assessment — protection against electrical hazards
Evidence is normally handled inside the medical-device registration route.
Source association reviewed
Wireless / radio
ARTCI homologation of radioelectrical equipment
Maintained as a mandatory pre-market route.
Source association reviewed
Telecom terminal
ARTCI homologation of terminal equipment connected to a public network
Maintained as a mandatory pre-market route.
Source association reviewed
Radiation
ARSN authorisation, licence, enregistrement or agrément for ionizing-radiation activities
Applies when the product, feature, component, or use is in scope.
Source association reviewed
Import CoC / PVoC
AIRP prior declaration (listing) by every actor in the device supply chain
Handled as an import or shipment-level obligation.
Source association reviewed
Official starting points
Use these authority pages to confirm current scope, technical rules, application routes, and transition dates. A linked source does not turn a preliminary result into an authority decision.
AIRP (Autorité Ivoirienne de Régulation Pharmaceutique)
Modalités d'homologation des dispositifs médicaux — declaration/listing of every supply-chain actor, the Autorisation de Commercialisation dossier and its five-year validity, the conformity check-list against the essential requirements, and the redevances table
AIRP (Autorité Ivoirienne de Régulation Pharmaceutique)
UEMOA Décision n° 03/2022/CM/UEMOA portant adoption des lignes directrices relatives à l'harmonisation de la réglementation des dispositifs médicaux — published in the AIRP's own document library
UEMOA — Commission de l'Union économique et monétaire ouest-africaine (texte intégral des lignes directrices et de leurs annexes, hébergé par l'Agence béninoise du médicament)
Décision n° 03/2022/CM/UEMOA and annexes I-1 (device classes and rules), I-2 (DMDIV classes and rules), II-1 (essential requirements for devices) and II-2 (essential requirements for DMDIV)
ARTCI (Autorité de Régulation des Télécommunications/TIC de Côte d'Ivoire)
Ordonnance n° 2012-293 du 21 mars 2012 relative aux Télécommunications et aux Technologies de l'Information et de la Communication, titre VI « Homologation des équipements et agrément d'installateurs », arts. 88-93, Journal officiel du 14 août 2012, p. 154
ARTCI
Homologations — demande d'homologation d'équipement terminal et/ou radioélectrique and the lists of equipment homologated by the ARTCI
ARTCI
Formulaire de demande d'homologation d'équipement terminal et/ou radioélectrique — application form, technical characteristics annex
ARSN (Autorité de Radioprotection, de Sûreté et de Sécurité Nucléaires)
Décision n° 000010 ARSN/DG du 6 janvier 2026 modifiant la décision n° 000005 ARSN/DG du 3 mai 2021 — conditions de délivrance, de renouvellement, de modification, de suspension et de retrait d'une autorisation ou d'un agrément (arts. 3-8 thresholds, 12-14 dossier contents, 16-19 the 45-day and 21-day periods, 33-35 validity, 39 renewal window)
ARSN
Autorisastion — the ARSN's definition of an authorisation, the licence and enregistrement scopes, and the downloadable forms
ARSN
Agrément — the service activities subject to ARSN agrément, including installation of ionizing-radiation radiology equipment
Ministère de la Santé, de l'Hygiène Publique et de la Couverture Maladie Universelle — Direction de l'Activité Pharmaceutique
Politique Pharmaceutique Nationale — Côte d'Ivoire (version 2, 10 October 2023): the AIRP's creating law (loi n° 2017-541 du 3 août 2017) and organising decree (décret n° 2018-926 du 12 décembre 2018), and the DPML-to-AIRP reform
About this checker
A preliminary tool, not a regulatory determination
Describe the complete product — radio, power, measurement, radiation, battery, materials, accessories, intended use, import route, and existing approvals. The free checker maps those facts to the maintained Côte d'Ivoire scheme matrix and links each route to its maintained source associations, with reviewed, candidate and unresolved states shown separately.
Use the result to identify questions and official sources. Final scope can depend on exact models, modules, bands, components, claims, HS codes, import structure, installation site, and current authority interpretation.
- Is this the same as medical device classification in Côte d'Ivoire?
- No. Risk classification determines the main medical-device pathway. This checker runs after classification and looks for additional product certificates, dossier evidence, import documents, and facility or operator licences.
- Does “no separate certificate” mean no testing is required?
- No. Safety, EMC, performance, or other evidence can still be required inside the medical-device dossier even when there is no separate national product certificate.
- Is the result an official regulatory determination?
- No. It is a preliminary applicability assessment. Review the linked official source and confirm the final route with the relevant authority, certification body, importer, or regulatory professional.
DJ Fang
MedTech Regulatory Expert
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