The new article describes the implementation process related to changes to registered medical devices. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document...
The new article highlights the key points related to the application process to be followed when notifying the authority about the changes to registered medical devices. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the...
The new article provides an overview of flowcharts describing the change type assessment. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the...
The new article highlights the aspects related to the changes to registered medical devices implemented in response to adverse events, the context of field safety corrective actions, and also the ones that are not subject to change notification requirements. Table of...
The article describes in detail the way the changes to medical devices are divided into categories and also highlights the key points to be considered in this respect. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere...