REGULATORY AUTHORITY: Ethiopian Food and Drug Authority (EFDA)
CLASSIFICATION SYSTEM:
Medical Devices: I/II/III/IV
IVDs: A/B/C/D
TIME FRAME: No official timelines are published by the authority, however, according to our experience it will take up to 1 month to register low-risk products and up to 6 months to register medium to high-risk products.
SPECIAL REQUIREMENTS: Inspection to a foreign manufacturing facility (for high risk devices) might be required after or before the dossier evaluation is completed. A desktop inspection (document review) is applicable for manufacturers approved by Stringent Regulatory Authorities (SRAs) and/or World Health Organization (WHO) prequalified products.
LOCAL FEES (New Application):
Medical Devices and IVDs (all classes)
New product registration: USD 65 (including dossier pre-screening and evaluation)
Minor variation: USD 15
Major variation: USD 20
Annual retention fee (renewal): USD 20
LOCAL FEES (Manufacture):
Foreign manufacturing facility inspection:
On-site: USD 7,500
Desktop: USD 3,500
LICENSE VALIDITY: 5 years
LICENSE TRANSFER: The license holder can be switched to the new one by cancelling the old license holder and then appointing the new one. New product registration is required.
AUTHORIZED REPRESENTATIVE: Manufacturers without local presence must appoint a company or legal person established within Ethiopia to become their Authorized Representative (AR).
Other Sub-Saharan African Countries: Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Central African Republic, Chad, Comoros, Congo, DR Congo, Equatorial Guinea, Eritrea, Gabon, Gambia, Ghana, Guinea, Guinea – Bissau, Ivory Coast, Kenya, Lesotho, Liberia, Madagascar, Mali, Mozambique, Namibia, Niger, Nigeria, Rwanda, Senegal, Sierra Leone, Somalia, South Africa, South Sudan, Swaziland, Tanzania, Togo, Zanzibar
