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Costa Rican Medical devices regulation basics
Here below are reported some of the most relevant guidance for Medical Device Registration in Costa Rican market:
Major Regulations
Regulation Year Establishing regulation of health products in Costa Rica 1973 Regulations on registration, classification, import, and control of medical equipment and biological materials 1973 General Guidance Documents
Document Year Addresses formal recognition of US FDA approvals as exceeding Costa Rica’s safety standards 2002 Relating to Fees for Registering Medical Devices and other Biomedical Equipment 2005 Specific Guidance Documents
Document Year Procedures to determine the equivalency of sanitary registration systems of biomedical device and material 2002 Doubts?
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Doubts ?
Reach out to us and we will help you clarify your situation