Medical Device Regulatory Requirements in Bolivia
| Regulatory Authority |
State Agency for Medicines and Health Technologies |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
I,IIa,IIb,III |
| Medical Device Regulations |
Technical Inventory Manual of Medical Devices and Equipment and Infrastructure
| Click Here
|
| IVD Classification |
A,B,C,D |
| Registration Process |
Manual for Health Registration of Medical Devices
| Click Here
|
| Registration Timeline |
1 month to 12 months depending on classification |
| Language Requirement |
Labels must be in Spanish Language |
| Additional Information |
Within a period of 30 business days from the date of entry to the Directorate of Medicines and Health Technology, the original Health Registration Certificate will be delivered with a validity of 5 years |
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 We are not responsible for errors, omissions, or outdated content.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