Feb 2, 2022
Ethiopia
The second article addresses the matters related to Quality Management System and documentation associated thereto. Table of Contents The Ethiopian Food and Drug Authority (EFDA), a country’s regulatory agency in the sphere of healthcare products, has...
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Feb 1, 2022
Ethiopia
The first article provides an overview of the guidelines published recently by the Ethiopian authority for storing and distributing medical devices. Table of Contents The Ethiopian Food and Drug Authority (EDFA) has published guidelines dedicated to the...
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May 7, 2021
Africa
Ethiopian Food and Drug Authority (EFDA), the country’s regulating authority in the sphere of healthcare products, has published guidelines dedicated to the regulatory procedures for placing low-risk medical devices on the market. The document constitutes the initial...
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May 20, 2020
Africa
The Ethiopian Food and Drug Authority (EFDA), Ethiopia’s national authority responsible for medical device regulation, has provided draft guidance regarding proposed changes to the rules and regulations on post-approval changes of medical devices. The appropriate...
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