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.
Other Sub-Saharan African Countries:
Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Central African Republic, Chad, Comoros, Congo, DR Congo, Equatorial Guinea, Eritrea, Gabon, Gambia, Ghana, Guinea, Guinea – Bissau, Ivory Coast, Kenya, Lesotho, Liberia, Madagascar, Mali, Mozambique, Namibia, Niger, Nigeria, Rwanda, Senegal, Sierra Leone, Somalia, South Africa, South Sudan, Swaziland, Tanzania, Togo, Zanzibar
* Note: If you use your general ISP e-mail address, such as gmail, yahoo etc. your LinkedIn profile address is required to process your request.