Ethiopia
Ethiopia is located in the Horn of Africa region of East Africa and is the second most populous country on the continent, after Nigeria, with over 130 million inhabitants.
Ranked 6th in terms of GDP, it is a state with over 80 different ethnic groups with as many different languages spoken. Coffee is one of the main export products next to the growing export of flowers and plants. Ethiopia is one of the most rapidly urbanizing countries in the world, although its population is still largely rural. Addis Ababa being the capital and by far the largest city. Around 4% of GDP is spend on healthcare, with the majority being out-of-pocket spending. Besides governments spending, there is also a community-based health insurance scheme (CBHI) which targets informal sector workers and rural communities. A Social Health Insurance (SHI) scheme for the formal sector has its challenges when it comes to the implementation. International donors and development partners play a significant role as well (which makes the system vulnerable on the long term).
Healthcare system structure
The healthcare system is organized into three tiers:
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Primary Level:
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Health Posts: Community-level facilities staffed by health extension workers (HEWs) providing basic preventive and promotive services.
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Health Centers: Serve as referral centers for health posts, offering outpatient, inpatient, and basic laboratory services.
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Primary Hospitals: Provide more comprehensive care, including basic surgical and obstetric services.
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Secondary Level:
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General Hospitals: Serve as referral facilities for primary hospitals, offering specialized care and diagnostic services.
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Tertiary Level:
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Specialized Hospitals: Offer advanced medical care and serve as teaching and research institutions.
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Governance and decentralization
The Federal Ministry of Health (FMoH) is responsible for the national health policy, strategic planning, and resource mobilization. The Regional Health Bureaus (RHBs) oversee healthcare delivery within Ethiopia's federal regions. Finally, the District Health Offices (Woreda or District Level): Implement health programs at the community level.
Like in many African countries, Ethiopia has a shortage of skilled health professionals and faces an uneven distribution, with most professionals concentrated in urban areas. Incorporating digital health solutions (telemedicine and eHealth tools) is an important strategy of the Ethiopian government going forward.​
Key health issues
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High prevalence of communicable diseases like HIV/AIDS, malaria, tuberculosis, and neglected tropical diseases.
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Increasing burden of NCDs. Growing focus on diabetes, hypertension, and cancer as lifestyles change.
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Maternal Mortality: While improving, maternal mortality remains a concern at ~267 deaths per 100,000 live births (2023 estimate).
Medical device and IVD registration
The registration and regulation of Medical devices and IVDs in Ethiopia falls under the responsibility of the Ethiopian Food and Drug Authority (EFDA). The aim is to ensure safety, quality, and performance of these products.
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Device classification
Medical devices and IVDs are classified according to different systems of classification where each system takes into account several criteria.
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Medical devices are classified into four classes (I, II, II, IV) based on their risk:
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Class I: Low risk (e.g., tongue depressors, Surgical retractors).
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Class II: Low-Moderate risk (e.g., Hypodermic needles/ suction equipment).
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Class III: Moderate-High risk (e.g., Lung ventilators, bone fixation plate)).
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Class IV: High risk (e.g., Heart valves/ implantable defibrillator).
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IVDs are classified into four classes (A,B,C & D) based on their risk as below:
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Class A: Low individual risk & low public health risk (e.g., Clinical Chemistry Analyzer, Prepared selective culture media)
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Class B: Moderate individual risk &/or low public health risk (e.g., Vitamin B12, pregnancy self-testing, urine test strips, Anti-Nuclear Antibody)
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Class C: High individual risk &/or moderate public health risk (e.g., blood glucose self-testing, HLA typing, PSA screening, Rubella)
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Class D: High individual risk & high public health risk (e.g., HIV blood donor screening, HIV blood diagnostic)
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Pre-Registration Requirements / authorized representative (AR)
Foreign manufacturers must appoint a local agent or authorized representative registered in Ethiopia. The local agent will acton the behalf of the legal manufacturer in relation with regulatory affairs, keep the communication with EFDA and will be responsible for submitting applications and ensuring compliance.
The application is to be processed via the EFDA online portal and then physically submitted /handed over at the EFDA offices along with all required documentation:
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Completed application form
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Application Letter
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Agency Agreement: this agreement should be signed between the Legal manufacturer and its local authorize representative in Ethiopia who would act on the manufacturer’s behalf in relation with Regulatory affairs.
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Certificate of Free Sale (CFS) or equivalent from the country of origin.
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Quality Management System Certificate: ISO 13485 or equivalent.
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Declaration of Conformity: Demonstrating compliance with international standards (e.g., CE marking, FDA approval).
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Receipt of service fees, (non-refundable)
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Product Labelling and Instructions for Use (IFU).
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Technical File: Including device description, design, manufacturing, and performance data.
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Clinical Data or Evidence: Especially for higher-risk devices.
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Post-Market Surveillance (PMS) Plan.
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Risk Analysis Report: Identification and mitigation of potential risks.
Further documents along with specific labeling requirements are requested based on the class of the medical device and on other criteria as well.
We recommend to work closely with a local expert to identify which documents are required for each case.
Submission, validity and post approval obligations
A thorough evaluation and assessment process is mainly reserved for medical devices and IVDs with high risk level, while Class I/A MDs/VDS have been exempted from such a process. Therefore, the timeline would be lower compared to the timeline which is necessary to get higher risk medical devices and IVDs registered.
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Once the Application is successfully submitted, EFDA evaluates the documentation for completeness and technical compliance. If compliant, EFDA issues a Certificate of Registration, valid for five years. For imported devices, an Import Permit may also be required.
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Post-market monitoring is mandatory, especially for high-risk devices. Adverse events, malfunctions, or product recalls must be reported to EFDA.
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Applications for Minor and/or major variations must be submitted to EFDA along with the payment of the related service fee.
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Applications for renewal must be submitted to EFDA along with the payment of the related service fee at least six months before the certificate expires.
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Risk-Based Timelines: Class I/A devices have shorter approval timelines compared to Class II/C and IV/D.
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Onsite Inspection: EFDA may conduct inspections of the local distributor, manufacturer facilities, as well as foreign manufacturing facilities particularly for higher-risk devices.
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Donor-Funded Products: Devices funded by donors (e.g., WHO, UNICEF) often have expedited pathways but still require EFDA approval.
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Lengthy approval times for complex devices.
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EFDA's growing adoption of digital tools and harmonized regulatory standards is making the process more efficient.
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Increasing focus on local manufacturing and innovation.
