![EFDA Guidelines on Marketing Authorization: Requirements for Virtual Manufacturers](https://www.regdesk.co/wp-content/uploads/2022/04/MT2101_Advanced_-Manufacturing_1536997286_1200.jpeg)
Apr 14, 2022
Ethiopia
The new article describes in detail specific aspects related to the products placed on the market by virtual manufacturers and highlights the main points related to the responsibilities of all the parties involved in supplying medical devices in Ethiopia. ...
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![EFDA Guidelines on Marketing Authorization: Post Approval](https://www.regdesk.co/wp-content/uploads/2022/04/istockphoto-647374066-612x612-1.jpeg)
Apr 9, 2022
Ethiopia
The new article addresses the aspects related to the post-approval stage, such as the validity of the certificates or changes thereto. Table of Contents The Ethiopian Food and Drug Authority (EFDA), a country’s regulatory agency in...
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![EFDA Guidelines on Marketing Authorization: Exemptions and Application Review](https://www.regdesk.co/wp-content/uploads/2022/04/ethiopia-flag-pin-map-paper-series-image-67800269.jpeg)
Apr 4, 2022
Ethiopia
The new article provides an overview of the exemption rules to be applied when considering the applicability of the medical device registration rules. Table of Contents The Ethiopian Food and Drug Authority (EFDA), a country’s regulatory...
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![EFDA Guidance on Application Pathways: Documents and Procedures](https://www.regdesk.co/wp-content/uploads/2022/03/Medical-Device-Design-and-Development-A-Definitive-Guide-for-Medtech-Professionals-1280x720-1-1080x675.jpeg)
Mar 29, 2022
Ethiopia
The new article provides additional details regarding the documents to be included in the submission dossier and also highlights some important aspects related to the procedures to be followed when applying for marketing approval. The general principles and...
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![EFDA Guidelines on Submission Pathways and Requirements: General Principles and Requirements](https://www.regdesk.co/wp-content/uploads/2022/03/ethiopia-flag-weaving-beautiful-orange-sunset-clouds-background-193350587.jpeg)
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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![EFDA Guidelines on Conformity Assessment of Medical Devices: Documentation](https://www.regdesk.co/wp-content/uploads/2022/03/medical-mask-flag-ethiopia-hands-doctor-stethoscope-flat-lay-coronavirus-pandemic-209529233.jpeg)
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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