Costa Rica Ministry of Health medical device registration under RTCR 505:2022. Single Costa Rica Registration Holder. All-inclusive annual fee included.
Timelines confirmed at proposal stage
Costa Rica's Ministerio de Salud registers medical devices under RTCR 505:2022 through the Regístrelo portal. Single Costa Rica Registration Holder (CRH), but the CRH can authorize multiple downstream distributors on one registration. bioaccess® acts as the CRH through our own Costa Rican 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 Costa Rica.