Medical Device Regulatory Requirements in Chile
| 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 |
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 We are not responsible for errors, omissions, or outdated content.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