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 November 8th, 2021.
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.
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): Not applicable.
LICENSE VALIDITY: 5 years
LICENSE TRANSFER: The license holder can be switched to the new one by cancelling the old license holder and then appoint the new one. New submission by the new license will be 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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