Medical Device Registration and Approval in Ethiopia
General country-specific regulatory information is provided on this page for medical device registration and approval in Ethiopia .
Last updated on February 17th, 2022.
Medical Device Regulations and Classification in Ethiopia
REGULATORY AUTHORITY: Ethiopian Food and Drug Authority (EFDA)
Medical Devices: I/II/III/IV
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
Please fill out your contact information so we can better assist you.
* Note: If you use your general ISP e-mail address, such as gmail, yahoo etc. your LinkedIn profile address is required to process your request.