Costa Rica Medical Device Regulations

All documents were published by the Costa Rican Ministry of Health and are in PDF format. The Costa Rica Ministry of Health updates their database of approved devices on a monthly basis: Costa Rica Ministry of Health database of approved devices (in Spanish).

Major Regulations

Establishing regulation of health products in Costa Rica es 53951973
Regulations on registration, classification, import, and control of medical equipment and biological materialses 34482-S1973

General Guidance Documents

Addresses formal recognition of US FDA approvals as exceeding Costa Rica's safety standardses DM-F-1518-20112002
Relating to Fees for Registering Medical Devices and other Biomedical Equipmentes 3278010/2005

Specific Guidance Documents

Procedures to determine the equivalency of sanitary registration systems of biomedical device and materiales DAJ-RM-1151-082002