Medical Device Regulatory Requirements in Argentina
| 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 |
| Requirement of Authorized Representative |
Yes |
| Language Requirement |
Labels must be in Spanish Language |
| Database |
Medical Products Database
| 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. |
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 We are not responsible for errors, omissions, or outdated content.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