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