Côte d'Ivoire medical device registration resources

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).

Art. 19 gives the applicant "un délai de vingt et un (21) jours calendaires pour donner suite au courrier de demande de complément de son dossier", failing which a reasoned rejection notice is sent.

Art. 6 puts radioactive sources of category 1 to 4 and generators with a tension greater than or equal to 30 kV under a licence; art. 7 puts generators strictly below 30 kV and category 5 sources under enregistrement. The ARSN website still publishes a 40 kV licence threshold on its authorisation page, which the 2026 decision supersedes; the instrument governs.

This is not an AIRP device clock and does not replace one: a device that generates or contains a radiation source still needs its AIRP Autorisation de Commercialisation or its listing declaration, and the ARSN authorisation is held by the operator using the device.

The published period is route-wide rather than class-specific: it applies to every authorisation and agrément under the decision, whatever the practice, so the row carries the route-wide exemption rather than a risk-class link.