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Ethiopian Medical Devices Regulatory Authority

The regulatory body for medical device registration in Ethiopia is the Ethiopian Food and Drug Authority (EFDA), which is under the jurisdiction of the Ministry of Health.

EFDA is mainly responsible for the market access, quality management, and post-market supervision of medical devices.

Regulatory Authority's Official Website Link:https://www.efda.gov.et/

Administrative Regulation

[ Food and Medicine Administration Proclamation 1112 ]

[GUIDELINE FOR REGISTRATION OF MEDICAL DEVICES]

Risk Level Classification of Medical Device and IVD Products

Medical device classification:

IVD Product classification:

Entry Requirements

ISO 13485 certificate

Product information, including packaging and labelling, a list of devices covered by the scope of application, and relevant additional information

Ethiopian Authorized Representative: Letter of attorney and agency agreement

Free sale certificate or marketing authorization certificate

Declaration of Conformity (DOC)

Registration Language

English.

Authorized Representative of Ethiopia

Foreign manufacturers should appoint an Ethiopian local representative who will be responsible for submitting applications and communicating with the regulatory authorities on behalf of the manufacturer.

Local representatives should hold the import license certificate issued by EFMHACA when importing medical device products.

The application process must be carried out by the local representative.

Registration Flow, Cycle & Official Fee

1. Registration Flow

2. Official Fee

Official fees

Application initial review fee for new applicants: 350 Bils

New application review fee: 1300 birr

Laboratory testing fee: $20

Renewal application review fee: 870 Bils

Review fee for major change application: 870 Bils

Minor change application review fee: 650 Bils

Agency agreement fee: $50

Chapter 3 FAQ

Q: How to do the renewal of the registration of medical devices in Ethiopia?

A: After four years, 120 days before the expiration of the application, submit the required data or documents to the regulatory authority to ensure continued compliance with the equipment.

Q: How to deal with changes in the process of medical device registration application?

A: Changes: If there are any significant changes that may affect the safety or effectiveness of medical devices, such as changes in manufacturing processes, facilities, equipment, quality control procedures, equipment design, intended use, etc., the authority shall be notified and approved before implementation. Other changes shall be immediately notified to the Authority and may be implemented without prior approval.

Application for Amendment: An application for amendment to an existing registered product (such as an addition of a product) is generally considered a new application for documentation purposes, but certain administrative documents (such as institutional agreements and company profiles) may not be required. Applicants should follow the appropriate sections of this Guide to prepare documentation based on the proposed product category.

All requests for changes and amendments should be made in writing and accompanied by the appropriate fee.

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