Ethiopia

General

Country: Ethiopia
Geographic region: East Africa
Income level (World bank): 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
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