Ethiopia's healthcare sector is undergoing rapid transformation, with increasing emphasis on access to quality medical devices and in vitro diagnostics (IVDs). To ensure the safety, quality and performance of these products, the Ethiopian government has established a robust regulatory framework. … Read More
The medical devices market in Ethiopia is on the rise, driven by a confluence of factors. A growing population, increasing prevalence of chronic and infectious diseases, and rising healthcare expenditure are key contributors the medical device market opportunities in Ethiopia. … 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
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
