Ethiopia
The new article provides additional details regarding the regulatory requirements to be applied concerning labeling for certain types of medical devices, including the in vitro diagnostic (IVD) and sterile products, as well as active and implantable medical devices. ...
Ethiopia
The new article describes in detail certain specific aspects related to the labeling for medical devices intended to be marketed and used in Ethiopia, including the way the labeling should be placed and the information it should contain. ...
Ethiopia
The article provides an overview of the regulatory requirements for medical device labeling introduced in Ethiopia. Table of Contents The Ethiopian Food and Drug Authority (EFDA), a country’s regulatory agency in the sphere of healthcare...
Asia
The first article describes the regulatory background for labeling requirements, provides definitions of key terms, and also highlights the main points related to the general requirements for labeling including the way the safety and use-related information should be...
EU MDR/IVDR
The Spanish Agency of Medicines and Medical Devices (AEMPS) announced the extension of the period provided for medical device manufacturers to implement changes to labeling required due to Brexit. A General Overview of the Brexit Consequences It is important to...
