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, through the Dirección de Regulación de Productos de Interés Sanitario, registers medical devices under Reglamento Técnico RTCR 505:2022 — "Equipo y Material Biomédico. Clasificación, Registro, Importación, Etiquetado, Publicidad, Vigilancia y Control" — submitted through the Regístrelo portal governed by Decreto Ejecutivo N° 37988-S, under the authority of Ley General de Salud N° 5395. RTCR 505:2022 confirms that the product title holder or their legal representative can authorize third parties for importation or distribution — as long as it is indicated in the registration request. There is still a single registered title holder — the CRH — but the CRH can authorize multiple downstream distributors on one registration. bioaccess® acts as the CRH through our own Costa Rican entity. See the LATAM Importer of Record guide for the full country breakdown.
Costa Rica is quoted case by case and is not part of the published fixed-price plan (Mexico, Colombia, Brazil, Peru, Argentina). Your quote states government fees, translations and holder service. RF homologation for wireless devices runs through Costa Rica's separate telecom authority and is quoted separately.
Market Access hub · LATAM registration pricing · LATAM Importer of Record guide
Related: Clinical trials in Costa Rica.