Medical Device Regulatory Requirements in Costa Rica
| Regulatory Authority |
Ministry of Health |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
I,II,III,IV |
| Medical Device Regulations |
Medical Device Regulation: Decree No. 34482-S
| Click Here
|
| Registration Timeline |
For FDA approved products, it takes 3 months else 8 months |
| Requirement of Authorized Representative |
Yes |
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.
The above information is last updated on 09/Apr/2025