Geographical Location:
South Africa is located at the southern tip of the African continent, bordered by Namibia, Botswana, Zimbabwe, Mozambique, Eswatini (Swaziland), and Lesotho. It has a long coastline along the Atlantic and Indian Oceans.
Language(s):
South Africa … Read More
The regulation and registration of medical devices and in vitro diagnostic (IVD) devices in Ghana are overseen by the Ghana Food and Drugs Authority (FDA), under the Public Health Act, 2012 (Act 851). All medical devices and IVDs intended for … Read More
Ensuring the safety, efficacy, and quality of medicines is paramount for public health. In Ethiopia, this responsibility falls under the purview of the Ethiopian Food and Drug Authority (EFDA), which has established comprehensive guidelines to perform the regulation duties of … Read More
Kenya is one of African major countries who have established a regulatory framework for medical devices. The country performs all the core regulatory activities including- licensing of establishments, registration of products, regulatory inspection, clinical trial oversight and other regulatory functions … Read More
The ISO 13485- Medical devices- Quality management system- for regulatory purposes is an international standard developed by a recognized international standard body- International Organization for Standardization (ISO) first in 2003 with the latest version released in 2016. It is written … Read More
The medical devices market in Ethiopia is on the rise, driven by different factors. A growing population, increasing prevalence of chronic and infectious diseases, and increased healthcare expenditure are key contributors to the rise of medical device market opportunities in … Read More
This blog simplifies the procedures and guidelines set for medicines and medical devices special import permit by Ethiopian Food and Drug Authority.
The healthcare system relies on a steady flow of vital medical products. … 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
