The Ethiopian Food and Drug Authority (EFDA), with technical support from the three levels of the World Health Organization (WHO), conducted an assisted self-benchmarking of Ethiopia’s national regulatory system for medical devices, including in vitro diagnostics, from 27 to 31 July 2026.
The exercise assessed strengths and gaps in the regulatory system and informed the updating of EFDA’s Institutional Development Plan. It marks an important step towards strengthening public health protection, building confidence in medical devices, advancing regulatory harmonization and work-sharing, and supporting local manufacturing and access to export markets.
The assessment used the WHO Global Benchmarking Tool Plus Medical Devices (GBT+MD), which evaluates regulatory systems against more than 250 indicators. Assisted self-benchmarking is a WHO-guided preparatory assessment distinct from the formal benchmarking, through which WHO independently evaluates a regulatory system to determine its maturity level.
Opening the exercise, Professor Francis Kasolo, WHO Representative to Ethiopia, the African Union and the United Nations Economic Commission for Africa, emphasized that strong regulatory systems not only protect patients but also create an enabling environment for innovation, local manufacturing and economic opportunities.
Agnes Sitta Kijo, Technical Officer with WHO’s Regulatory Systems Strengthening team, explained that the assessment covered seven regulatory functions: national regulatory systems; registration and marketing authorization; post-market surveillance; market surveillance and control; licensing of establishments; regulatory inspections and laboratory testing; and clinical trial oversight.
During the week-long exercise, EFDA staff assessed the regulatory system against the GBT+MD indicators, while WHO experts provided technical guidance and supported verification of the findings. The exercise concluded with EFDA and WHO reviewing the findings and agreeing on an updated Institutional Development Plan and a roadmap towards formal WHO benchmarking.
Ethiopia achieved WHO Maturity Level 3 for the regulation of medicines and vaccines as a non-producing country in 2025. EFDA Director General Heran Gerba said the experience and institutional capacity gained through this achievement had prepared EFDA to apply the same commitment to strengthening the regulation of medical devices.
Medical devices – from diagnostic tests and thermometers to surgical equipment – are essential for disease prevention, diagnosis, treatment and monitoring. With an estimated 2 million kinds of medical devices available globally, effective regulatory oversight is critical to ensuring their safety, quality and performance.
Professor Kasolo reaffirmed WHO’s commitment to supporting Ethiopia in strengthening its regulatory system for medical devices and other medical products, including vaccines and blood and blood products, contributing to improved access to safe, effective and quality-assured health products.
Distributed by APO Group on behalf of WHO Regional Office for Africa.
