| Regulatory Authority | Ethiopian Food and Drug Authority |
|---|---|
| Regulatory Authority Website Link | Click Here |
| Device Classification | I,II,III,IV |
| Medical Device Regulations | Medical Device Guidelines | Click Here |
| IVD Classification | A,B,C,D |
| In Vitro Diagnostics Regulations | Guideline for Classification of In Vitro Diagnostic Medical Devices Guideline for Registration Requirements of In Vitro Diagnostic Medical Devices |
| Registration Process | Guideline for Registration of Medical devices 2014 | Click Here |
| Registration Timeline | 4 to 6 months whereas class I take around 45 days |
| Requirement of Authorized Representative | Yes |
| Language Requirement | Labels must be in English and/or Amharic Language |
| Database | eRIS | Click Here |
| Adverse Event Reporting Form | Download |
| Additional Information | Any applicant requesting special import permit (pre-import permit) of medicine and medical device should apply through the authority's Electronic Regulatory Information System (eRIS). |