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Medical devices are regulated by the FMHCACA (Food, Medicine, and Health Care Administration and Control Authority).
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.
Medical devices are licensed within 3-6 months.
Licenses issued in Ethiopia are valid for five years.
An authorized representative is required.
Last Updated on February 9 2015.
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For more information on registration in Ethiopia, check out the following articles on our blog:
Country at a Glance: Ethiopia