ARCSA medical device registration and local holder in Ecuador for FDA-cleared and CE-marked products. Required local company. All-inclusive annual fee.
Timelines confirmed at proposal stage
ARCSA requires a locally registered Ecuadorian company as the single registration holder. Foreign manufacturers cannot hold ARCSA registrations directly. bioaccess® holds through our own local Ecuadorian entity.
Market Access Essentials / LATAM Launch Subscription: USD 7,500 per year per country for the first device family. Includes government submission fees, sworn translations, in-country titular/RH/IOR, and tecnovigilancia as holder. Additional families quoted on request.
All-inclusive annual subscription includes government submission fees, in-country registered agent, regulatory liaison, and certified/sworn translations where required. Electrical/EMC and RF homologation for wireless devices are handled through the country’s telecom authority at vendor cost plus a 20% G&A handling fee.
Market Access hub · LATAM registration pricing · LATAM Importer of Record guide
Related: Clinical trials in Ecuador.