The ML3 roadmap, explained
On September 16, 2026, WHO and EFDA agreed on a roadmap to WHO Maturity Level 3 for medical devices — after ML3 for medicines in October 2025 and a device self-benchmarking in July 2026.
Free field guide · PDF
Ethiopia Medical Device Registration2026 Field Guide
What manufacturers need to know before entering Africa's second-largest market — the WHO-EFDA ML3 roadmap, registry data, and how filing works today.
- H1 2026 approvals
- 848
- Registered devices
- 5,915
- People
- 130M
Sourced from WHO, EFDA, and June 2026 registry data.
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What's inside
Six pages, zero fluff
Every figure in this guide traces to a named source — WHO, EFDA, or the June 2026 registry analysis.
Registry numbers that matter
848 registrations cleared in H1 2026 (a record pace), 5,915 devices on the national register, and why China and India supply two-thirds of them.
How registration works today
Filings run through the eRIS portal, a local authorized representative is required, and what to watch as requirements evolve.
Sources & scope
- WHO Regional Office for Africa press release, 16 September 2026.
- EFDA official news, July 2026 — WHO-assisted self-benchmarking, 27–31 July 2026.
- MedDeviceGuide EFDA eRIS registry analysis (June 2026 data).
This guide is market-access intelligence, not legal or regulatory advice. Regulatory requirements change — professional review is required before business use.
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