Medical Device Regulatory Requirements in Colombia
| Regulatory Authority |
National Institute for Food and Drug Surveillance (Invima) |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
I,IIa,IIb,III |
| Medical Device Regulations |
Medical Device Market Authorization
| Click Here
|
| IVD Classification |
I, II, III |
| In Vitro Diagnostics Regulations |
In Vitro Diagnostic Reagents and In Vitro Reagents |
| Registration Timeline |
For low-risk devices, it takes up to 1 month and for high-risk devices, it takes 5 to 6 months. |
| Requirement of Authorized Representative |
Yes |
| Language Requirement |
Labels must be in Spanish Language |
| Additional Information |
Health records and marketing permits will be valid for ten (10) years from the issuance of the corresponding administrative act. |
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 We are not responsible for errors, omissions, or outdated content.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