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.



ARE YOU INTERESTED IN REGISTRATION IN ETHIOPIA? REQUEST A FREE QUOTE>​

For​ more information on registration in Ethiopia, check out the following articles on our blog:
Country at a Glance: Ethiopia
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