ABSTRACT

Singapore, a microcosm of Asia and Asia's gateway is ideal for medical technology companies seeking to expand their reach. Medical devices to be manufactured, imported, or sold in Singapore are regulated by the Health Sciences Authority (HSA). Telehealth products are instruments, apparatus, machines, software, and mobile applications that are used in the provision of telehealth services. Telehealth service is the provision of healthcare services over distance via infocomm technologies and is categorized into three broad service areas: clinical services, education, and administration. The HSA, a statutory board of the Singapore Ministry of Health, was formed with a vision to be the leading innovative authority protecting and advancing national health and safety and comprises the following: Health Products Regulations Group, Blood Services Group, and Applied Sciences Group. A Dental Grouping Terms (DGT) grouping of dental medical devices is a collection of dental devices. All adverse event (AE) reports received by the HSA are reviewed and subject to trend detection analysis.