ARCSA medical device registration in Ecuador for FDA-cleared and CE-marked products. Local company must hold and import. Manufacturer-funded processing service.
Timelines confirmed at proposal stage
Ecuador is a single-holder market. ARCSA requires that a registration be applied for by a locally registered Ecuadorian company, which becomes the single registration holder — foreign manufacturers cannot hold ARCSA registrations directly. Because the holder is local and single, registration ownership is a real commercial lever: a distributor that becomes the holder controls market access. Registration ownership is not divisible. Whoever pays for the registration controls it: a distributor that funds the filing will hold it hostage and refuse transfer. bioaccess® processes your ARCSA 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 Ecuador: the titleholder must also be the importer, so there is no annual holder fee to quote. ARCSA 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 Ecuador'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 Ecuador.