ANMAT
The article provides an overview of the new regulation and highlights the key points associated thereto.
HSA
The new article highlights the aspects related to the information to be included in the submissions with respect to manufacturing processes and sites involved. Table of Contents The Health Sciences Authority (HSA), a Singapore’s regulatory agency in the sphere of...
FDA
The article addresses the aspects related to the existing legal framework associated with AST system devices and highlights the key points to be considered. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in...
Africa
This article highlights what CE marking is, how to obtain it, and the steps to follow to comply with EU regulations. Table of Contents Medical devices manufacturers willing to market products in the European Union (EU), must comply with the regulations established...
Canada
This article highlights he current regulations for medical devices in Canada, the process of registering compliant devices, potential changes being considered, and the potential impact on stakeholders. Table of Contents The use of medical devices is essential in...
CDRH
This article highlights the details of the adverse event reporting regulations in the European Union (EU) and the United States (US), their similarities, differences, and their impact on medical device safety. Table of Contents Ensuring the safety and effectiveness of...
