Ethiopia's journey towards economic prosperity and improved healthcare has been marked by significant progress in recent years. With the goal of attaining lower-middle-income status by 2025, the Government of Ethiopia introduced the ambitious 10 Years Perspective Plan (2020/2021 to 2029/2030). … Read More

This blog simplifies the Ethiopian Food and Drug Authority's (EFDA) guideline on obtaining a special import permit for medical products.

Ensuring Access to Critical Medical Products

The healthcare system relies on a steady flow of vital medical products. But sometimes, … Read More

The world of medical products can be complex, especially when it comes to borderline products that blur the lines between medical devices and medicinal products. This ambiguity can pose challenges for manufacturers and healthcare professionals alike. This article aims to … Read More

The Ethiopian market is seeing a rise in medical devices, and ensuring their safety and effectiveness is crucial. The Food and Medicine Administration Proclamation No. 1112/2019 plays a key role in this by requiring registration for all medical devices. But … Read More

Ethiopian Food and Drug Authority is a governmental organization mandated by Food and Medicine Administration Proclamation 1112/2019, that has been in effect since February 2019, to ensure a high level of protection of public health and safety. Public trust and … 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, distribution, use to disposal. These regulatory controls are divided into different sequential regulatory functions/pathways- … 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

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