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Resources

Learning Materials

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Governance Documents

Association Bylaw & Regulations

The official governing bylaw of the Medical Advancement Association. (Document is in Amharic.)

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Ethiopia Digital Health Policy

Digital Health in Ethiopia: Policy Framework for Private Sector Engagement

A 2021 policy framework examining how the private sector can support Ethiopia's digital health ecosystem.

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Ethiopia Digital Health Blueprint

The national blueprint guiding the design and implementation of Ethiopia's digital health system.

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Ethiopia Information Revolution Strategic Plan (2018–2025)

The Ministry of Health's strategic plan for using health information to strengthen the health system.

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Ethiopia's Information Revolution: Using Digitalization to Improve the Health System

A practice brief on Ethiopia's Information Revolution initiative and its impact on health data and services.

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Digital Ethiopia 2030

Ethiopia's national digital transformation strategy and vision through 2030.

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Health Sector Transformation Plan II (2020/21–2024/25)

Ethiopia's Ministry of Health five-year plan for transforming the national health sector.

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Innovation & Bioeconomy Strategy

Ethiopian Bioeconomy Strategy

Ethiopia's national strategy for building a sustainable, innovation-driven bioeconomy.

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Ethiopia's Readiness for Establishing a National Bio-Innovation Hub

An assessment of Ethiopia's readiness to establish a national hub for bio-innovation.

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National Science, Technology and Innovation Policy of Ethiopia

Ethiopia's national policy for building competitiveness through science, technology, and innovation.

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Legal & Regulatory Documents

Ethiopian Standard Industrial Classification (ESIC)

The official classification system for economic activities and industries in Ethiopia.

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Ethiopia Startup Proclamation No. 1396/2025

The proclamation establishing Ethiopia's legal framework for startups.

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Personal Data Protection Proclamation No. 1321/2024

Ethiopia's law governing the collection, use, and protection of personal data.

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Research Institution and Industry Linkage Proclamation

The proclamation governing collaboration between research institutions and industry in Ethiopia.

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Software & AI in Medical Devices

FDA Perspective on Software as a Medical Device

The US FDA's overview of how software is regulated as a medical device.

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Guidelines for Software as a Medical Device (Ethiopian FDA)

The Ethiopian Food and Drug Authority's guidelines for software and AI-based medical devices.

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Software as a Medical Device (SaMD): Clinical Evaluation — FDA Guidance

FDA guidance for industry on the clinical evaluation of software as a medical device.

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US FDA Artificial Intelligence and Machine Learning Discussion Paper

An FDA discussion paper exploring regulatory approaches for AI/ML-based medical software.

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