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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Feb 16, 2022
Ethiopia
The new article covers the aspects related to recalls of medical devices to be taken by responsible entities to eliminate risks to patients, including the factors to be considered when deciding on the actions to be taken. Table of Contents The...
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Feb 9, 2022
Ethiopia
The new article provides additional details regarding the documents required when importing medical devices in Ethiopia, as well as the information these documents should contain. Additionally, the article describes the procedures to be followed when importing medical...
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Feb 8, 2022
Ethiopia
The second article addresses certain specific matters related to periodic management reviews, complaints handling, and also the actions to be taken for returned medical devices. Table of Contents The Ethiopian Food and Drug Authority (EFDA), a country’s...
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Feb 5, 2022
Ethiopia
The first article provides an overview of importation requirements and outlines the main principles thereof. Table of Contents The Ethiopian Food and Drug Authority (EFDA), a country’s regulating authority in the sphere of healthcare products, has...
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