FDA
The new article addresses the matters related to labeling requirements the devices should comply with in order to be allowed for marketing and use in the country. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in...
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 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...
