Medical Device Registration in
Ministry of Health
Medical Device Regulation
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