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 |