In Singapore, telehealth devices must undergo product registration and obtain market clearance prior to importation. The process for product registrations is the same as that currently used in the healthcare industry.
The introduction of telehealth technology has revolutionized the healthcare industry in Singapore. With this technology, patients located in rural areas can be assessed remotely by doctors and can manage and monitor their health without attending a hospital. According to recent news, a trial concluded at the end of 2017 by the National University Health System (NUHS) was the first to utilize telehealth technology in Singapore.
With the rapid growth of this technology, the monitoring of the usage, safety, and performance of such devices has been enforced by the Singapore Health Science Authority (HSA). The HSA has published guidelines to ensure that telehealth products marketed in Singapore comply with the rules and regulations stipulated by the Authority.
According to the HSA, a telehealth product is defined as an instrument, apparatus, machine or software (including mobile applications) that are involved in the provision of healthcare services over physically separated environments via infocomm technologies (including mobile technology). These include telecollaboration, teletreatment, telemonitoring and telesupport devices.2
Prior to importation and supply, such devices must undergo product registration and obtain market clearance following current processes used by the industry. Similar to the product registration requirements for medical devices in Singapore, the product owner must appoint a ‘Registrant’ and utilize a local distributor to distribute the product locally.