Chapter 1 Ethiopian EFDA Administration Information Abstract

1. Administration and Abstract

The administration for the registration of medical devices in Ethiopia is the Ethiopian Food and Drug Authority (EFDA), which is under the Ministry of Health. EFDA is mainly responsible for market access, quality management, and post-market supervision of medical devices.

2. Administrative Regulation

[ Food and Medicine Administration Proclamation 1112 ]   

[GUIDELINE FOR REGISTRATION OF MEDICAL DEVICES]

3. Risk Level Classification of Medical Device and IVD Products

Medical device classification:

IVD Product classification:

4. 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)

5. Registration Language

English.

6. Authorized Representative of Ethiopia

The foreign manufacturer shall appoint a local representative in Ethiopia who will represent the manufacturer in filing and communicating with the regulatory authority.

The local representative shall hold an import license issued by EFMHACA when importing medical device products.

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

Chapter 2 Registration Flow, Cycle & Official Fee

1. Registration Flow

2. Cycle & Official Fee

Registration cycle

New product Registration: $65 (including pre-review and evaluation of documents)

Official fees

New product Registration: $65 (including pre-review and evaluation of documents)

Minor changes: $15

Major variance change: $20

Annual retention fee (renewal) : $30

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.