If it is to achieve a consistent success, the primary task of any business entity should be being legally acceptable. I want you to know the legal principle- “Ignorance of the law excuses no man from practicing it”. … Read More

From 2018 on, Food and Drug Authority (FDA) of Ethiopia started implementing the rules of appropriate bundling of different medical devices into a single registration request application. Bundling or grouping devices is a very important strategy to enable the assessors … Read More

In order to fully understand EFDA’s comprehensive registration requirements and make request for the Marketing Authorization of In vitro diagnostic medical devices, I recommend you to download and read the guideline that is attached below (in PDF format).

Here, I … Read More

In order to fully understand EFDA’s comprehensive registration requirements and make request for the Marketing Authorization of Non In vitro diagnostic medical devices, I recommend you to download and read the guideline that is attached below (in PDF format).

Here, … Read More