Costa Rica Ministry of Health medical device registration under Reglamento Técnico RTCR 505:2022. Single Costa Rica Registration Holder authorizes multiple downstream distributors. All-inclusive annual fee.
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.
First device family low-to-mid risk USD 7,500/yr, all-inclusive. Additional families +USD 3,500/yr.
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 Costa Rica.