Asia
The new article highlights the aspects related to the form and manner of reporting, responsible parties, as well as procedures and activities associated with reporting. Table of Contents The Health Sciences Authority (HSA), a Singapore’s regulatory agency in the...
Asia
The article provides an overview of the changes to the applicable classification rules with respect to a specific category of medical devices. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products,...
Asia
The new article highlights the key points related to reporting adverse events associated with in vitro diagnostic medical devices and also describes the applicable reporting timelines. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory...
Asia
The article provides an overview of the regulatory requirements in the sphere of adverse event reporting. Table of Contents The Health Sciences Authority (HSA), a Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document...
Asia
The new article covers the aspects related to the device-specific advertising requirements, as well as to the corrective measures to be taken with respect to non-compliances identified. Table of Contents The Health Sciences Authority (HSA), a Singapore’s regulatory...
