Costa Rica Regulatory Framework Medical Device registration
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
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
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 |
