Ethiopian Food and Drug Authority (EFDA) (Ethiopian)
The Ethiopian Food and Drug Authority (EFDA) is a federal regulatory body established under Proclamation No. 1263/2021 and its mandate defined under regulation No. 531/2023. EFDA was established to safeguard the public’s health by ensuring the safety and quality of food, the safety, quality, and efficacy of medicines, the safety, quality, and functionality of medical devices, as well as the safety of cosmetics and other health products. It also regulates alcohol and tobacco products to reduce their consumption and protect the public from devastating consequences of death, disability and disease.
1. Product Registration with EFDA
All medical devices must obtain Marketing Authorization from EFDA prior to importation. The registration process involves:
- Application Submission: Through EFDA’s Electronic Regulatory Information System (eRIS).
- Required Documentation:
- Completed application form.
- Device description and intended use.
- Technical documentation, including design and manufacturing details.
- Quality Management System (QMS) certificates, such as ISO 13485.
- Clinical evaluation reports, if applicable.
- Labeling and Instructions for Use (IFU) in English.
- Certificate of Free Sale or equivalent from the country of origin.
- Declaration of Conformity.
EFDA recognizes approvals from Stringent Regulatory Authorities (SRAs) like US FDA, EMA, Health Canada, and others.
2. Appointment of a Local Authorized Representative
Foreign manufacturers are required to appoint a local authorized representative in Ethiopia. This representative must:
- Be a legally registered entity in Ethiopia.
- Hold a valid import business license.
- Possess a certificate of proficiency issued by EFDA.
- Be responsible for the registration process, communication with EFDA, and post-market surveillance activities.
An agency agreement between the manufacturer and the local representative is mandatory.
3. Importation Requirements
Once the device is registered, the following documents are required for importation:
- Import Permit issued by EFDA.
- Commercial Invoice.
- Packing List.
- Airway Bill (AWB) or Bill of Lading (B/L).
- Certificate of Analysis (CoA) for sterile devices.
- Certificate of Refurbishment, if applicable.
EFDA conducts inspections at ports of entry to verify compliance with regulatory requirements before releasing the products.
4. Special Import Permits
In certain situations, such as emergencies, shortages, or for personal use, EFDA may grant Special Import Permits for unregistered medical devices. Applicants must:
- Submit a justification letter explaining the need for the special import.
- Provide relevant supporting documents.
- Apply through EFDA’s eRIS platform.
These permits are typically granted to hospitals, research institutions, non-profit organizations, or individuals with documented medical needs.
5. Post-Market Surveillance
Manufacturers and their local representatives are responsible for:
- Monitoring the performance of the medical devices in the market.
- Reporting adverse events and taking corrective actions when necessary.
- Ensuring continuous compliance with EFDA regulations.