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. ...
Asia
The article provides a brief overview of Pakistan’s regulatory requirements in the sphere of importation and exportation of medical devices and highlights the key points to be considered by medical device manufacturers and other parties involved in placing medical...
Ethiopia
The new article provides additional details regarding the documents to be included in the submission dossier and also highlights some important aspects related to the procedures to be followed when applying for marketing approval. The general principles and...
FDA
The first article provides an overview of the guidance document dedicated to the human factors and the way they should be considered when developing user interfaces for medical devices. Table of Contents The Food and Drug Administration (FDA or the...
FDA
The present article details FDA guidance on software testing, including tests performed by the manufacturer (software developer) regarding potential changes to the software. The basics of software testing are described in the initial article. The Food and Drug...
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