Asia The first article describes the regulatory background for labeling requirements, provides definitions of key terms, and also highlights the main points related to the general requirements for labeling including the way the safety and use-related information should be...
Asia The second article of the HSA series provides an in-depth review of the Singapore structure of the submission for marketing approval and the details about the product and manufacturing process it should contain. Table of Contents The Health Sciences...
Asia The first article highlights the most important aspects related to the application for medical device registration and the way it should be submitted. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of...
Asia The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of medical devices and other healthcare products, has published a FAQ document dedicated to 3D-printed medical devices. The document provides additional clarifications on the applicable...
Asia The second article in our series covering HSA Guidance in Telehealth Products focuses the applicable classification rules for Telehealth products, and also specific regulatory controls these products are subject to. The Health Sciences Authority (HSA), Singapore’s...
