| 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 |
| Contact Phone | (591-2) 2119831 - (591-2) 2112598 |
| Contact Address | Aspiazu Street No. 666 (Between Abdón Saavedra and Ecuador) Sopocachi Area |