The Ethiopian Food and Drug Authority (EFDA) has completed an assisted self-benchmarking of the country’s regulatory system for medical devices and in vitro diagnostics, conducted with technical support from WHO from 27 to 31 July 2026.
For device manufacturers, importers and distributors working in Ethiopia, the exercise signals where regulatory requirements are heading. The assessment covered seven functions — national regulatory systems, registration and marketing authorisation, post-market surveillance, market surveillance and control, licensing of establishments, regulatory inspections and laboratory testing, and clinical trial oversight — and its findings feed into an updated Institutional Development Plan. Companies should expect requirements in registration, establishment licensing and post-market surveillance to tighten as EFDA works towards formal benchmarking. For local device manufacturers, a maturity rating for devices would matter commercially: it is the mechanism through which regulatory work-sharing and export-market recognition operate.
The exercise 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 and is distinct from formal benchmarking, in which WHO independently evaluates a system to determine its maturity level. EFDA staff carried out the assessment against the indicators while WHO experts provided guidance and supported verification of findings. The exercise concluded with agreement on an updated Institutional Development Plan and a roadmap towards formal 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 that achievement had prepared the authority to apply the same commitment to medical devices.
Professor Francis Kasolo, WHO Representative to Ethiopia, the African Union and the UN Economic Commission for Africa, said strong regulatory systems protect patients and create an enabling environment for innovation, local manufacturing and economic opportunity. Agnes Sitta Kijo, technical officer with WHO’s Regulatory Systems Strengthening team, set out the seven functions covered. Kasolo reaffirmed WHO’s support for Ethiopia across medical products including vaccines and blood products.
No findings from the assessment were published, and neither strengths nor gaps identified were disclosed. No date was given for formal benchmarking, and no maturity level currently applies to Ethiopia’s regulation of medical devices.
Source: World Health Organization, Addis Ababa: https://www.afro.who.int/countries/ethiopia/news/advancing-regulation-medical-devices-through-who-assisted-self-benchmarking
