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).
| 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 |
| 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 |
| Document | Language | Number | Published |
|---|---|---|---|
| Procedures to determine the equivalency of sanitary registration systems of biomedical device and material | es | DAJ-RM-1151-08 | 2002 |
Since the publication of ISO 13485:2016, risk management is a major concern for maintaining regulatory compliance in major medical device markets.
read moreAll documents were published by the Costa Rican Ministry of Health and are in PDF format. The Costa Rica Ministry of Health updates their database
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