Général
|
| Pays |
Ethiopia |
| Région géographique: |
East Africa |
| Le niveau de revenu (Banque mondiale ): |
Low income |
| Population (women 15-49 years) in millions, 2015: |
23,9 |
| Are condoms (male/female) regulated in the country? |
yes |
| If yes, describe the applicable regulation or directive: |
Guidelines for registration of medical devices in Ethiopia |
| Condom classification (medical device, medicines, others): |
Class II medical device |
| National competent (regulatory) authority: |
Food, Medicine & Healthcare Administration and Control Authority of Ethiopia (FMHACA) |
Essential Medicines List
|
| Condoms on EML? |
yes |
| Female condoms specified on EML? |
no |
| EML Version (year): |
2014 |
Registration Requirements
|
| Applicant eligibility: |
Manufacturer or authorised local representative |
| Administrative documents: |
Manufacturing license; All documents should be authenticated by Ethiopian Embassy in the country of origin. |
| Technical documents: |
"Quality system certification; Free sale certificate in the country of manufacture; Site master file; Product dossier; Stability study report; Report on pre-clinical and clinical studies; Copy of product label; List of countries where product is registered. " |
| Sample: |
Sample of product and labeling materials |
| Process: |
Complete set of documents (both hard and soft copies) must be submitted by the authorised local agent to product registration & licensing directorate. |
| Timeline: |
3 months from the date of submission |
| Registration Fee: |
US$ 500 |
| Validity of registration: |
5 years |
