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)


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 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).

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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.


Did you know you can onboard your medical device or IVD compliance information to our system in less than 15 minutes?

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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