Mar 28, 2022
Ethiopia
The new article provides an in-depth review of existing application submission pathways an interested party may follow when placing its product on the market. In particular, the present article describes the general principles and requirements to be considered when...
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Mar 21, 2022
Ethiopia
The new article provides a detailed overview of the regulatory requirements related to documentation to be submitted by an entity interested in placing its medical device on the market. Table of Contents The Ethiopian Food and Drug Authority...
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Mar 14, 2022
Ethiopia
The new article highlights the most important aspects related to conformity assessment of medical devices intended to be marketed and used in Ethiopia. In particular, the present article provides an overview of the conformity assessment in general and also outlines...
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Mar 10, 2022
Ethiopia
The present article describes in detail the aspects related to the Ethiopian classification rules for both general and in vitro diagnostic medical devices, as well as the criteria for medical devices grouping when applying for marketing authorization. ...
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Mar 5, 2022
Ethiopia
The new article addresses the matters related to ancillary activities conducted by the entities involved in operations with medical devices including but not limited to dispatching medical devices to end-users, and also the activities that could be outsourced. ...
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