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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Feb 28, 2022
Ethiopia
The new article describes the aspects related to various operations with medical devices and the way they should be undertaken by all the parties involved. Table of Contents The Ethiopian Food and Drug Authority (EFDA), the country’s regulating...
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Feb 19, 2022
Ethiopia
The new article addresses the regulatory aspect related to premises used to store medical devices before they will be supplied and describes the approach to be applied when receiving new medical devices and organizing their storage. Table of...
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Sep 3, 2021
EU MDR/IVDR
SwissMedic, the Swiss regulating authority in the sphere of medical devices, has published a guidance document dedicated to the obligations of parties involved in operations with medical devices, other than manufacturers: authorized representatives, importers, and...
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