Costa Rica Medical Device Regulations
Log into RAMS to download the documents listed below along with more regulations and guidances for Costa Rica.
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Download | Regulations on registration, classification, import, and control of medical equipment and biological materials | 34482-S | 1973 | Spanish |
| Download | Establishing regulation of health products in Costa Rica | 5395 | 1973 | Spanish |
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Download | Relating to Fees for Registering Medical Devices and other Biomedical Equipment | 32780 | 10/2005 | Spanish |
| Download | Addresses formal recognition of US FDA approvals as exceeding Costa Rica's safety standards | DM-F-1518-2011 | 2002 | Spanish |
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Download | Procedures to determine the equivalency of sanitary registration systems of biomedical device and material | DAJ-RM-1151-08 | 2002 | Spanish |
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