Medexa is a Quito-based regulatory affairs firm that publishes a “Representación Legal y Holding Regulatorio” service for foreign manufacturers that want to register products in Ecuador without setting up a local company. The service page is at medexapro.com/representacion-legal-y-holding-regulatorio (retrieved 20 October 2026). This article uses only what Medexa publishes, then compares it with the multi-country market access offer from bioaccess®.
What Medexa publishes
Medexa says it acts as titular regulatorio in Ecuador for foreign manufacturers with no local structure, “especialmente en dispositivos médicos.” The holding page lists two parts:
- Representación regulatoria: formal action before ARCSA, Agrocalidad and other authorities; acting as the local solicitante for registros sanitarios and notificaciones sanitarias; coordination with manufacturers, distributors and logistics operators; follow-up of requirements, renewals and post-registration processes.
- Holding regulatorio: regulatory titularity independent of the commercial distributor, continuity if the importer or commercial strategy changes, and central management of a portfolio of Ecuadorian registrations.
Its FAQ says a foreign manufacturer does not necessarily need an Ecuadorian company, that who keeps the titularity “depends on the regulatory strategy,” and that the structure can be migrated by a regulated transfer if the manufacturer later opens its own subsidiary. Medexa also covers pharmaceuticals, cosmetics, foods and supplements, and veterinary and aquaculture products, plus BPM/HACCP/ISO systems and trademark registration before SENADI. We found no public price on the site.
The pitch fits Ecuador. As summarized in the bioaccess® LATAM registration guide, an Ecuadorian registration must be held by a local Ecuadorian company, a single holder, under Resolución ARCSA-DE-026-2016-YMIH (as reformed), which Resolución ARCSA-DE-2026-003-DASP will replace when it takes effect on 28 January 2027. A titular that is not your distributor lets you change or add importers without losing the registro.
Medexa vs bioaccess®
| Dimension | Medexa (Ecuador) | bioaccess® |
|---|---|---|
| Public product | Local representation and regulatory holding before ARCSA, plus dossiers, quality systems and trademarks | Medical device registration and market access across Latin America, with holder, importer of record where applicable, and tecnovigilancia roles in the published-price countries |
| Geography | Ecuador | 19 Latin American and Caribbean markets, including Ecuador (ARCSA) |
| Product mix | Devices, pharmaceuticals, cosmetics, foods, veterinary and aquaculture products | Medical devices, with a first-in-human clinical trial path before registration |
| Public pricing | None published | Published two-part pricing for Mexico, Colombia, Brazil, Peru and Argentina (one-time registration fee, then a lower annual holder fee from year 2); Ecuador quoted case by case |
| Contract term | Not published | No multi-year contract required |
| Bridge from a clinical trial | None published | Same firm can run the LATAM clinical trial and then hold the commercial registration |
Where each one fits
If Ecuador is the only market on the plan and a local titular separate from your distributor is the whole job, Medexa’s published offer covers it, and it says the right things about keeping the registration independent of the seller.
bioaccess® is a different product. It runs first-in-human trials and then registers devices across Latin America. In Mexico, Colombia, Brazil, Peru and Argentina the pricing is published on the LATAM registration rate card: a one-time registration fee per country and class, then a lower annual holder fee from year 2, with initial government fees and certified translations included up to a stated cap. Where local law requires a local party in those countries, bioaccess® acts as registration holder (in Colombia, as your attorney-in-fact), importer of record where applicable, and tecnovigilancia contact. Ecuador and the other covered markets are quoted case by case.
One country and a local titular is enough? Hire the shop that publishes that job. Several LATAM labels under one partner who is not your distributor? Start at bioaccess® market access or request a registration quote.