Honduras ARSA medical device registration for FDA-cleared and CE-marked products. Local legal representative required. Manufacturer-funded processing service.
Timelines confirmed at proposal stage
Honduras registers medical devices through ARSA under Acuerdo No. 0631-ARSA-2023 (signed 28 December 2023; published in La Gaceta No. 36,646 on 21 September 2024 and in force 20 days after publication). The regulation requires a local legal representative domiciled in Honduras for each registration and a responsible technical professional at the establishment. Article 40 allows two or more registrations of the same device by different registrants when there is no exclusive distributor, but whoever pays for a registration controls it: a distributor that funds the filing will hold it hostage and refuse transfer. bioaccess® processes your ARSA registration funded by you, the manufacturer — dossier, translations, agency liaison — while your distributor is titleholder and importer of record on paper only, with tight transfer-upon-demand clauses in your distribution agreement (reviewed by local counsel) forcing transfer to your designee on your demand. See the LATAM Importer of Record guide for the full country breakdown.
bioaccess® sells registration processing — not a holder subscription — in Honduras: the local legal representative must be the importing entity, so there is no annual holder fee to quote. ARSA government submission fees are set by the regulator; certified Spanish translation of IFU, labels, and technical file is typically required. RF homologation for wireless devices runs through Honduras's separate telecom authority. Registration processing and hostage-proof contracting are quoted as a scoped engagement: dossier preparation, translations, agency liaison, and tecnovigilancia.
Market Access hub · LATAM registration pricing · LATAM Importer of Record guide
Related: Clinical trials in Honduras.