Regulatory Authority
Food, Medicine and Healthcare Administration and Control Authority of Ethiopia (FMHACA)
Classification
I, II, III, IV
Quality system
ISO 13485:2016 or equivalent
Medical Devices and IVDs are subject to registration procedure.
A Local Representative, representing the manufacturer to the Regulatory Authority, should be appointed.
The Local Representative should hold a license (issued by the Ministry of Trade) and a certificate of competence (issued by FMHACA) at the time of importation of the product.
Application procedure must be performed by the Local Representative.
Applicant
Local Representative.
Timeframe and fees
In general, it takes about 3 to 6 months to get approval for new registrations.
In case of modifications / changes from the existing registrations, the timeframe is exactly the same.
Validity
4 years
Labelling and documentation language
Documentation and labelling must be provided in English.
Useful information
Product Registration and marketing experience at least in a Country other than the Country of origin is required.
