Costa Rica Medical Device Regulations

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Major Regulations
Document Number Published Language
Download Regulations on registration, classification, import, and control of medical equipment and biological materials 34482-S 1973 Spanish
Download Establishing regulation of health products in Costa Rica 5395 1973 Spanish
General Guidance Documents
Document Number Published Language
Download Relating to Fees for Registering Medical Devices and other Biomedical Equipment 32780 10/2005 Spanish
Download Addresses formal recognition of US FDA approvals as exceeding Costa Rica's safety standards DM-F-1518-2011 2002 Spanish
Specific Guidance Documents
Document Number Published Language
Download Procedures to determine the equivalency of sanitary registration systems of biomedical device and material DAJ-RM-1151-08 2002 Spanish