Ethiopia Begins WHO-Backed Assessment Of Medical Device Regulation

August 17, 2026
By Mintesinot Nigussie

Ethiopia has begun a WHO-backed assessment of its national regulatory system for medical devices and in vitro diagnostics, in a move aimed at identifying regulatory gaps and strengthening oversight of health products.

The Ethiopian Food and Drug Authority conducted the assisted self-benchmarking exercise from July 27 to 31, 2026, with technical support from the three levels of the World Health Organization.

The assessment used the WHO Global Benchmarking Tool Plus Medical Devices, which evaluates regulatory systems against more than 250 indicators. It covered seven regulatory functions, including product registration and marketing authorisation, post-market surveillance, market surveillance and control, licensing of establishments, regulatory inspections and laboratory testing, and clinical trial oversight.

The findings will be used to update the Ethiopian Food and Drug Authority’s Institutional Development Plan and establish a roadmap towards formal WHO benchmarking of the country’s medical device regulatory system.

The assisted assessment is distinct from formal WHO benchmarking. In the formal process, WHO independently evaluates a national regulatory system to determine its maturity level.

During the five-day exercise, Ethiopian Food and Drug Authority staff assessed the country’s regulatory system against the WHO indicators, while WHO experts provided technical guidance and helped verify the findings. The two sides concluded the exercise by reviewing the results and agreeing on an updated institutional development plan and roadmap.

Professor Francis Kasolo, WHO representative to Ethiopia, the African Union and the United Nations Economic Commission for Africa, said strong regulatory systems protect patients while creating an environment that supports innovation, local manufacturing and economic opportunities.

Heran Gerba, director-general of the Ethiopian Food and Drug Authority, said the authority’s experience in achieving WHO Maturity Level 3 for medicines and vaccines had strengthened its institutional capacity to regulate medical devices.

Ethiopia reached Maturity Level 3 for the regulation of medicines and vaccines as a non-producing country in 2025.

The medical device assessment covers products ranging from diagnostic tests and thermometers to surgical equipment. The WHO estimates that about two million types of medical devices are available globally, increasing the importance of effective regulatory oversight of their safety, quality and performance.

The assessment is also expected to support regulatory harmonisation and work-sharing, strengthen public confidence in medical devices, and help create conditions for local manufacturing and access to export markets.

WHO reaffirmed its support for Ethiopia’s efforts to strengthen regulation of medical devices and other health products, including vaccines and blood and blood products.

Source: FSX Business News