| Regulatory Authority | National Association of Medicines, Foods and Medical Technology (ANMAT) |
|---|---|
| Regulatory Authority Website Link | Click Here |
| Device Classification | I,II,III,IV |
| Medical Device Regulations | Medical Products Regulations | Click Here |
| Registration Process | Registration of Medical Products | Click Here |
| Registration Timeline | Class I and II take 4 to 6 months whereas Class III and IV takes 6 to 8 months |
| Technical Documentation Format |
Essential Requirements for Medical Products | Click Here |
| Requirement of Authorized Representative | Yes |
| Language Requirement | Labels must be in Spanish Language |
| Database | Medical Products Database | Click Here |
| Reportable Incidents |
Tecnovigilancia | Click Here |
| Additional Information | Based on the device's classification, it may be necessary to get either a Certificate of Free Sale (CFS) or a Good Manufacturing Practices (GMP) certificate. |