ARCSA medical device registration in Ecuador for FDA-cleared and CE-marked products. Local Ecuadorian registration holder required under Resolución ARCSA-DE-026-2016-YMIH (as reformed 2023). 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.
All-inclusive annual subscription per country; pricing under review — contact us for a quote.
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.
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Related: Clinical trials in Ecuador.