Costa Rica Medical Device Regulations
Log into RAMS to download the documents listed below along with more regulations and guidances for Costa Rica.
Related services for Costa Rica:
Related resources:
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Log in | Decree 41387-S Modifications to the Executive Decree No. 34482-S | 41387-S | ||
| Log in | Law 5395 General Health Law | 5395 | 1973 | |
| Log in | Regulation for the Registration, Classification, Importation, and Control of Biomedical Equipment and Material | 34482-S | 1973 |
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Log in | Decree 32780-S Establishing the Fees for Registration of Biomedical Equipment and Material | 32780-S |
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Log in | Decree 36868-S Regulation for the Authorization and Sanitary Control of the Advertising of Products of Sanitary Interest | 36868-S | ||
| Log in | Decree 41423-S Regulation for the Collection Procedures for Changes Subsequent to the Registration of Products of Sanitary Interest | 41423-S | ||
| Log in | CRECEX Alerta Informativa 31 Implementation of Recognition of US FDA Approval (US CFG) | 31 | ||
| Log in | Decree 39342-S Regulation for the National System of Technovigilance | 39342-S | ||
| Log in | Comunicado DAC-UPS-002-11 Implementation of Recognition of US FDA Approval (US CFG) | DAC-UPS-002-11 |
