This is where the documents including proclamation, regulation, directives and guidelines that are approved and currently being used by Ethiopian Food and Drug Authority for Medical device regulation are published.
In order to permit the marketability of medical devices in the Country, the Ethiopian Food and Drug Authority (EFDA) exercises different regulatory controls from their manufacture, distribution, use to disposal. These regulatory controls are divided into different sequential regulatory functions/pathways- … Read More
In order to permit the marketability of medical devices in the Country, the Ethiopian Food and Drug Authority (EFDA) exercises different regulatory controls from their manufacture to disposal. These regulatory controls are divided into different sequential regulatory functions/pathways- premarket product … Read More
Ethiopian Food and Drug Authority (EFDA) is a national regulatory body mandated to regulate food, medical products, tobaccos, and other similar products in the country before being distributed/marketed and used. Therefore, all devices which fulfil the medical device definition provided … Read More
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
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
