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 .

We review our Regulatory Information frequently; please check back often for updates

Medical Device Regulations and Classification in Ethiopia

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

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For detailed device-specific compliance information for each market, including Ethiopia , to expedite the preparation of your medical device or IVD registration application.

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And, in less than a minute, you can start your device-specific registration application and a complete county-specific registration process in this country or any of the other 140+ countries available for you through the Arazy Group Medtech registration platform.

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