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የኢትዮጵያ ምግብና መድኃኒት ባለስልጣን
Ethiopian Food and Drug Authority

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የኢትዮጵያ ምግብና መድኃኒት ባለስልጣን
Ethiopian Food and Drug Authority
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EFDA
Ethiopian Food and Drug Administration
EFDA
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EFDA
  • Home
  • About Us
    • About EFDA
    • Our Vision, Mission and Objectives
    • Organizational Structure
    • Advisory Board
    • Accreditations
    • Powers and Duties
  • News and Events
  • Services
    • Our Services
    • e-service
    • Traceability
      • FAQ’s
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    • Food Rapid Alert
    • Medical Device Safety
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    • All Publications
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      • Proclamations
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      • Strategic Plan
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      • Medicine Guidelines
      • Medical Device Directives
      • Cosmetic Directive
      • Food Directives
      • Pharmacovigilance
      • Clinical Trials
      • Tobacco
    • Strategies
    • Manuals
    • Drugs lists and formularies
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      • Food Bulletin
      • Drug Bulletin
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  • Directorates
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      • Medicine Sector Deputy Director General
      • Medical Device Sector Deputy Director General
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      • Director General Office
      • Branch Coordination Lead Executive Officer
      • Intelligence & illegal Trade Prevention Lead Executive Officer
      • Chief Executive Officer
    • Medicine Sector Deputy Director General
      • Medicine Manufacturers Inspection and Enforcement Lead Executive Officer
      • Medicine Quality Control Lead Executive Officer
      • Medicine Evaluation & Market Authorization Lead Executive Officer
      • Pharmacovigilance & Clinical Trial Lead Executive Officer
    • Food Sector Deputy Director General
      • Food Registration and Licensing Lead Executive Officer
      • Food Safety and Quality Testing Lead Executive Officer
      • Food Inspection and Enforcement Lead Executives Officer
    • Medical Device Sector Deputy Director General
      • Medical Device Manufacturers Inspection and Enforcement Lead Executive Officer
      • Medical Device Quality Control Lead Executive Officer
      • Medical Device Registration & Market Authorization Lead Executive Officer
    • Chief Executive Officer
      • Basic Service Executive Officer
      • Competence & Human Resource Management Executive Officer
      • Information & Technology Executive Officer
      • Organizational Change Management Executive Officer
      • Procurement & Finance Executive Officer
      • Strategic Affair Executive Officer
      • Women & Inclusive Social Affair Executive Officer
    • Branch Office Head
      • Administration and Finance Team
      • Entry and Exit Products Inspection Lead Executive Officer
      • Food & Medicine Quality Control lead Executive Officer
      • Food Control Lead Executive Officer
      • Medicine & Medical Device Control Lead Executive Officer
  • COVID19
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      • Ethiopian Public Assessment Report
      • Summary of product characteristics
      • Patient information leaflets
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የኢትዮጵያ ምግብና መድኃኒት ባለስልጣን
Ethiopian Food and Drug Authority
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  • amhአማርኛ
 
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Medical Devices Adverse Event Reporting (MDAER) form

By EFDAJuly 18, 2024

Ethiopian Food and Drug Authority (EFDA) Medical Devices Adverse Event Reporting (MDAER) form for Healthcare professionals and Users MDAER form

Guidelines for Software as Medical Devices

By EFDASeptember 28, 2022

Guidelines for Software as Medical Devices

Guidelines for Medical Device Refurbishment

By EFDASeptember 28, 2022

Guidelines for Medical Device Refurbishment

Guidelines for Medical Device Donations

By EFDASeptember 16, 2022

2022 08 29_Guidelines for Medical Device Donations

Guidelines for Medical devices Clinical Investigation Authorization

By EFDAJuly 26, 2022

Guidelines for Medical devices Clinical Investigation Authorization

Medical devices Decommissioning and Disposal Guideline

By EFDAJuly 18, 2022

Medical devices Decommissioning and Disposal Guideline

Medical Devices Recall Guideline

By EFDAJuly 18, 2022

Medical Devices Recall Guideline

Medical devices Post Marketing Surveillance Guideline

By EFDAJuly 18, 2022

Medical devices Post Marketing Surveillance Guideline

Guidelines for Medical Devices GMP Inspection

By EFDAMay 18, 2022

Guidelines for Medical Devices GMP Inspection

Guidelines for Medical device Labeling

By EFDAApril 28, 2022

Guidelines for Medical device Labeling

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  • Home
  • About Us
    • About EFDA
    • Our Vision, Mission and Objectives
    • Organizational Structure
    • Advisory Board
    • Accreditations
    • Powers and Duties
  • News and Events
  • Services
    • Our Services
    • e-service
    • Traceability
      • FAQ’s
    • Electronic Regulatory Information System(eRIS)
    • How eRIS works
    • e-Reporting of ADR
    • Food Rapid Alert
    • Medical Device Safety
  • Publications
    • All Publications
    • Policies, Legislation and Strategic Plan
      • Policies
      • Proclamations
      • Regulations
      • Strategic Plan
    • Directives and Guidelines
      • Medicine Directives
      • Medical Device Guidelines
      • Medicine Guidelines
      • Medical Device Directives
      • Cosmetic Directive
      • Food Directives
      • Pharmacovigilance
      • Clinical Trials
      • Tobacco
    • Strategies
    • Manuals
    • Drugs lists and formularies
      • Drug Lists
      • Drug Formulary
    • Bulletins and Newsletter
      • Food Bulletin
      • Drug Bulletin
      • Pharmacovigilance Newsletter
      • EFDA Newsletter
      • Articles
    • Ethiopian Traceability System
  • Directorates
    • Director General
      • Food Sector Deputy Director General
      • Medicine Sector Deputy Director General
      • Medical Device Sector Deputy Director General
      • QMS Lead Executive Officer
      • Director General Office
      • Branch Coordination Lead Executive Officer
      • Intelligence & illegal Trade Prevention Lead Executive Officer
      • Chief Executive Officer
    • Medicine Sector Deputy Director General
      • Medicine Manufacturers Inspection and Enforcement Lead Executive Officer
      • Medicine Quality Control Lead Executive Officer
      • Medicine Evaluation & Market Authorization Lead Executive Officer
      • Pharmacovigilance & Clinical Trial Lead Executive Officer
    • Food Sector Deputy Director General
      • Food Registration and Licensing Lead Executive Officer
      • Food Safety and Quality Testing Lead Executive Officer
      • Food Inspection and Enforcement Lead Executives Officer
    • Medical Device Sector Deputy Director General
      • Medical Device Manufacturers Inspection and Enforcement Lead Executive Officer
      • Medical Device Quality Control Lead Executive Officer
      • Medical Device Registration & Market Authorization Lead Executive Officer
    • Chief Executive Officer
      • Basic Service Executive Officer
      • Competence & Human Resource Management Executive Officer
      • Information & Technology Executive Officer
      • Organizational Change Management Executive Officer
      • Procurement & Finance Executive Officer
      • Strategic Affair Executive Officer
      • Women & Inclusive Social Affair Executive Officer
    • Branch Office Head
      • Administration and Finance Team
      • Entry and Exit Products Inspection Lead Executive Officer
      • Food & Medicine Quality Control lead Executive Officer
      • Food Control Lead Executive Officer
      • Medicine & Medical Device Control Lead Executive Officer
  • COVID19
    • COVID19 FAQ’s
    • COVID19 publications
    • COVID-19 Quick Access
    • Privacy Policy
  • Public Information
    • Approved Medicine Product Information
      • Ethiopian Public Assessment Report
      • Summary of product characteristics
      • Patient information leaflets
    • Products and Institutions
    • Appointed Inspectors
    • Measure Taken
  • Announcement
    • Tender
    • Notices
    • Vacancy
  • Contact