Ministry of Health

Ministry of Health (Ethiopia)

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

Registration Process

• 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