FDA The new article highlights specific aspects related to the clinical studies and the way they should be undertaken to ensure the accuracy and reliability of the results, including the patient demographics, safety endpoints, and analysis. The document constitutes a...
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. ...
Asia The new article highlights additional aspects related to the change notification process, including the turn-around time and fees. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of...
FDA The article addresses the aspects related to the study duration, and also the inclusion/exclusion criteria to be considered. The document constitutes a draft guidance the authority has published in order to collect feedback from industry representatives and other...
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. ...
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...
