Medical Device Registration in
Ethiopia
Ministry of Health
Regulatory Authority
Ethiopian Food and Drug Authority
Medical Device Regulation
GUIDELINE FOR REGISTRATION OF MEDICAL DEVICES
Guideline on Requirements of Medical Devices Clearance at Port of Entry
Official Language
Amharic
Classification
Class I, II, III, IV
Medical Device Registration in Ethiopia
- Medical Devices and IVDs are subject to the registration procedures.
- Determine the device classification
- Appoint an Authorized Representative.
- The Local Representative should hold a license (issued by the Ministry of Trade) and a certificate of competence at the time of importation of the product.
- Prepare the registration document and submit to EFDA.
- Once approved, the device can be marketed in Ethiopia.
Documents Required
- Application form dated and signed by an authorized representative of a company.
- List of devices covered by the scope of application, together with additional information about them.
- Authorization letter and agency agreement
- Marketing authorization status in other countries.
- Product information, including packaging and labelling
- Quality Management System certificate
- Free Sale Certificate or Certificate of Marketing Authorization
- Declaration of Conformity (DoC)
Applicable QMS
ISO 13485
Registration Timeline
3 to 6 months
Authorized Representative
Yes
License Validity
5 years
Special Notes
Labelling should be provided in English or Arabic