Medical Devices and In Vitro Diagnostic Medical Devices Market Opportunities in Ethiopia
Ethiopia's journey towards economic prosperity and improved healthcare has been marked by significant progress in recent years. With the goal ...
Medicines and medical devices special import permit by Ethiopian Food and Drug Authority
This blog simplifies the Ethiopian Food and Drug Authority's (EFDA) guideline on obtaining a special import permit for medical products ...
Identification of Borderline medical devices from medicinal products.
The world of medical products can be complex, especially when it comes to borderline products that blur the lines between ...
Simplifying Medical Device Approval in Ethiopia: A Guide to Low-Risk Devices Registration
The Ethiopian market is seeing a rise in medical devices, and ensuring their safety and effectiveness is crucial. The Food ...
Medical device manufacturing sites’ Quality management system audit by Ethiopian Food and Drug Authority
Ethiopian Food and Drug Authority is a governmental organization mandated by Food and Medicine Administration Proclamation 1112/2019, that has been ...
In Vitro Diagnostic medical devices Classification in Ethiopia (by Ethiopian FDA)
In order to permit the marketability of medical devices in the Country, the Ethiopian Food and Drug Authority (EFDA) exercises ...
Guidelines for Classification of Medical devices other than In Vitro diagnostic medical devices
In order to permit the marketability of medical devices in the Country, the Ethiopian Food and Drug Authority (EFDA) exercises ...
Regulatory Process of In Vitro Diagnostic Medical devices in Ethiopia
Ethiopian Food and Drug Authority (EFDA) is a national regulatory body mandated to regulate food, medical products, tobaccos, and other ...
Food and Medicine Administration Proclamation No: 1112/2019
If it is to achieve a consistent success, the primary task of any business entity should be being legally acceptable ...
How to group or bundle medical devices and submit in one application to register with EFDA
From 2018 on, Food and Drug Authority (FDA) of Ethiopia started implementing the rules of appropriate bundling of different medical ...