Costa Rica Medical Device Regulations
Costa Rica Medical Device Regulations
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 |