Africa The new article describes in detail the responsibilities of the parties involved in operations with medical devices in terms of post-marketing surveillance. Table of Contents The Ministry of Health of Kenya has published a guidance...
Africa The article provides an overview of the Kenyan regulatory requirements in the sphere of post-market surveillance for healthcare products. Table of Contents The Pharmacy and Poison Board, a division of the Kenyan Ministry of Health,...
Africa The article describes in detail the regulatory requirements related to the procedure of medical device establishment license renewal in South Africa based on the respective documents. Table of Contents The South African Health Products...
Africa The second article in our series covering EDA guidance on unique device identification, this article focuses on aspects related to the importation and delivery of medical devices. It also provides the definitions of the most important terms and concepts used in the...
Africa The Egyptian Drug Authority (EDA), a country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the unique device identification (UDI) requirements for medical devices. The document is intended to provide...
Africa The Egyptian Drug Authority (EDA), the country’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the requirements for unique device identification (UDI) for medical devices. The document is intended to provide...
