Ethiopia has begun a WHO-assisted self-benchmarking exercise to strengthen oversight of medical devices, with the Ethiopian Food & Drug Authority (EFDA) assessing the country’s regulatory system. The assessment evaluated the system against more than 250 indicators, covering product registration, post-market surveillance, inspections, laboratory testing and clinical trial oversight. It identified regulatory strengths and gaps that will guide revisions to EFDA’s institutional development plan and the preparation of a roadmap for formal WHO benchmarking. The initiative is expected to improve patient safety, support local medical-device manufacturing and promote regulatory harmonisation. It is also intended to improve access to export markets.

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