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Does my medical device need ARSN authorisation, licence, enregistrement or agrément for ionizing-radiation activities in Côte d'Ivoire?

Describe your device to check whether ARSN authorisation, licence, enregistrement or agrément for ionizing-radiation activities may apply, why, what facts are missing, and which official source to review.

1 maintained routes3 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.

Maintained country rule

What this ARSN authorisation, licence, enregistrement or agrément for ionizing-radiation activities check is screening

Separates product, supplier, import, facility, source-holder, and operator radiation obligations. Applies when the product, feature, component, or use is in scope.

Source association reviewed. The source association has been reviewed. This does not verify every rule, date or product-specific conclusion; read the cited provisions and their limits.

Requirement family: Ionizing radiation and radioactive sources
Regulatory object: radiation generator source or product practice
Maintained rule status: mandatory if feature
Useful product facts: X-ray or radioactive source, modality, energy, import purpose, installation site, and operator role.

Décision n° 000010 ARSN/DG du 6 janvier 2026, art. 4 requires any legal person intending an activity or practice involving exposure to ionizing radiation to obtain an authorisation or an agrément from the ARSN beforehand; art. 6 puts radioactive sources of category 1 to 4 and generators whose tension (kV) is greater than or equal to 30 under a licence, and art. 7 puts generators strictly below 30 kV and category 5 sources under enregistrement. The ARSN's own pages list the agrément activities (including "Installation des appareils de radiologie émetteur de rayonnements ionisants") and define an authorisation as permission to carry out a practice under loi n° 2013-701 du 10 octobre 2013. A device that generates or contains a radiation source therefore needs an ARSN authorisation held by the operator in addition to its AIRP registration.

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.

Product approval

A certificate or approval attached to the finished product, component, or radio host.

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

Other Côte d'Ivoire routes to check

Check every Côte d'Ivoire route →

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

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

Reviewed source associations

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.

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

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.