Singapore Releases Draft of Proposed Regulatory Guidelines on Software-based Medical Devices

With computer software increasingly central to the operations of many medical devices, Singapore’s medical authority is developing guidelines designed to ensure the quality of devices sold in the country which employ softwares. A draft of the guidelines released in late January by the Medical Devices Branch of Singapore’s Health Sciences Authority includes proposed requirements for licensing and registration of downloadable or web-based software, labeling requirements, the establishment of quality management and cybersecurity systems, and guidelines for post-market management of medical devices that employ software, including artificial intelligence.