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. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Ethiopia, to expedite the preparation of your medical device or IVD registration application.


Medical Device Regulations and Classification in Ethiopia

REGULATORY AUTHORITY: Medical devices are regulated by the FMHCACA (Food, Medicine, and Health Care Administration and Control Authority).

CLASSIFICATION SYSTEM: Devices are classified according to risk, with Class I being the lowest risk and Class III being the highest risk. IVD devices are classified similarly, with Class A as the lowest risk and Class D as the highest.

TIME FRAME: Medical devices are licensed within 3-6 months.

LICENSE VALIDITY: Licenses issued in Ethiopia are valid for five years.

AUTHORIZED REPRESENTATIVE: An authorized representative is required.

Last Updated on February 9 2015.


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