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According to Export.gov, the Government of Ethiopia is working to strengthen the healthcare system to align it with the Millennium Development Goals and it has made significant investments in the public health sector which have led to improvements in the health outcomes. Nevertheless, communicable diseases like HIV/AIDS,TB, malaria, respiratory infection, and diarrhea remain a serious challenge in Ethiopia. High fertility rates, and low contraceptive prevalence continue to drive a rapidly increasing population in Ethiopia. With a growing middle class, the GOE is facing an increase in non-infectious diseases such as cancer, diabetes, heart diseases, hepatitis B&C and high blood pressure.
The Ethiopian Food, Medicine and Health Care Administration and Control Authority has reported that there are currently more than 16,600 healthcare centers deliver health services in Ethiopia. The government encourages private sector participation in the area of quality of care and quality of service.
The government is also working with the private sector to build advanced tertiary care hospitals to meet domestic demand that would otherwise be met through outbound medical tourism, and ultimately to attract medical tourism to Ethiopia. The Ethio-American Hospital, which began construction in April 2017 and plans to begin operations by December2019, is an example of the government’s commitment to developing major new healthcare facilities. This project also demonstrates the government’s commitment to encouraging foreign investment in the sector through public private partnership (PPP) arrangements, according to Export.gov.
The Food, Medicine and Healthcare Administration and Control Authority of Ethiopia (FMHACA) is responsiblefor medical device regulation in Ethiopia. MedicalDevices and IVDs are subject to registration procedure.
A Local Representative, representing themanufacturer to the Regulatory Authority, should beappointed. In general, it takes about 3 to 6 monthsto get approval for new registrations and theregistration is valid for 4 years.