| Regulatory Authority | ANDID (National Agency for Medical Devices, Innovation, and Development) |
|---|---|
| Regulatory Authority Website Link | Click Here |
| Device Classification | I,II,III,IV |
| Medical Device Regulations | Decree 825 | Click Here |
| Registration Process | Registration and Authorization | Click Here |
| Registration Timeline | 3 months |
| Requirement of Authorized Representative | Yes |
| Language Requirement | Labels must be in Spanish Language |
| Additional Information | The authorization granted by the Institute will have a duration of three years and will be deemed successively and automatically renewed for equal periods |