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,...
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...
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...
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...
The new article describes in detail the main principles to be followed when advertising medical devices in Singapore. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulator agency in the sphere of healthcare products, has published a guidance...
The article provides an overview of the Singaporean regulatory requirements for advertising medical devices marketed in the country. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has...