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. ...
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. ...
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...
The article provides an overview of Singapore’s classification system for in vitro diagnostic medical devices. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a...
The new article addresses the requirements to be applied in specific cases, such as: Medical devices incorporating or administering medicinal or biological substance; Implantable medical devices; Medical devices intended to emit radiation; In-vitro diagnostic medical...