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Costa Rica

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Regulatory

Costa Rica Medical Device Registration Guide: Ministry of Health Process, Spanish Documentation, and LATAM Strategy

Complete guide to registering medical devices in Costa Rica — Ministry of Health (Ministerio de Salud) process under Decree No. 34482-S, four-tier classification based on Health Canada rules, two-phase legal and technical review, simplified pathway for FDA-cleared devices, Registration Holder requirements, Free Sale Certificate, Spanish labeling and IFU obligations, import permits, fees, timeline, and Central America market strategy.

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