Solumark is a Costa Rican regulatory firm that publishes a “Servicio de Representación de Registros de equipo médico” for foreign companies with no office in Costa Rica. The service is described on its services page at solumarkcr.com/servicios (retrieved 21 October 2026). This article uses only what Solumark publishes, then compares it with the multi-country market access offer from bioaccess®.
What Solumark publishes
Solumark explains that a Costa Rican sanitary registration involves four parties: the Responsable Sanitario / Titular del Registro (a national natural or legal person), the product owner, the manufacturer, and the distributors that the registration holder authorizes to import and sell. A company without a local office must designate a registration holder to deal with the Ministry of Health for it.
Solumark says it acts as that responsable sanitario for companies with no direct operation in Costa Rica that want to keep control of their registrations, so the rights to the registration are not handed to a distributor. The service, as published, covers:
- Coordinating and completing the registration documents required by the Costa Rican Ministry of Health.
- Managing changes, modifications, renewals, changes of distributor and cancellations of the registration certificate.
Solumark states it is neutral, is not a medical device distributor in Costa Rica, and has more than 15 years of experience. It also handles cosmetics registrations and runs training workshops. We found no public price on the site.
The pitch fits Costa Rica. As summarized in the bioaccess® LATAM registration guide, Costa Rica uses a single Costa Rica Registration Holder that imports under the registration (RTCR 505:2022; Decreto 37988-S under Ley General de Salud N° 5395) and may authorize downstream distributors. A holder that is not your distributor lets you change or add distributors without giving up the registration.
Solumark vs bioaccess®
| Dimension | Solumark (Costa Rica) | bioaccess® |
|---|---|---|
| Public product | Responsable sanitario / registration holder service before the Costa Rican Ministry of Health, plus device and cosmetics registrations and workshops | 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 | Costa Rica | 19 Latin American and Caribbean markets, including Costa Rica |
| Product mix | Medical equipment and biomedical material, cosmetics | 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); Costa Rica quoted case by case |
| Contract term | Not published | No multi-year contract required |
| Bridge from a clinical trial | None published | Trial-to-Market Bridge: 20% off for bioaccess® clinical-trial clients |
Where each one fits
If Costa Rica is the only market on the plan and an independent local registration holder is the whole job, Solumark’s published offer covers it, and it makes the right point about not ceding the registration to a distributor.
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, importer of record where applicable, and tecnovigilancia contact. Costa Rica and the other covered markets are quoted case by case.
One country and a local holder 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.