| Regulatory Authority | Center for State Control of Medicines, Equipment and Medical Devices., CECMED |
|---|---|
| Regulatory Authority Website Link | Click Here |
| Device Classification | I,IIa,IIb,III and IV |
| Medical Device Regulations | Approved Regulatory Provisions (Same Regulations for IVD) | Click Here |
| IVD Classification | A,B,C,D |
| In Vitro Diagnostics Regulations | Approved Regulatory Provisions |
| Device Classification Guidelines |
In Cuba, each piece of medical equipment or device is assigned one of the four existing Risk Classes, using classification rules . These rules correspond to the classification rules adopted in Europe. | Click Here |
| Registration Process | CECMED Resolution No. 19/2024: Regulation E 119-24 | Click Here |
| Requirement of Authorized Representative | YES |
| Language Requirement | Labels must be in Spanish Language |
| Clinical Trials Information |
CECMED is the competent authority responsible for evaluating and authorising the initiation of each clinical trial planned or proposed during the clinical evaluation strategy for the development of an investigational product. | Click Here |
| Adverse Event Reporting Form | Download |