Medical Device Registration in
Ministry of Health
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
Class I, II, III, IV
- 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.
- 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)
3 to 6 months
Labelling should be provided in English or Arabic