Singapore’s medical device market regulator, the Health Services Authority (HSA), has issued a notification indicating that Phase I implementation of its Unique Device Identification (UDI) regulations that it first announced in October 2020 and we covered here is commencing.
Beginning November 1, 2022, all medical devices under the closed list of high-risk implantable devices in the GN-36 guidance must comply with the HSA’s UDI requirements. Singapore’s UDI guidance lays out an international identification and tracking process aligned with the internationally harmonized principles published by the International Medical Device Regulators Forum (IMDRF). It also states that nothing in the new guidance will supersede GN-23, the existing guidance on device labeling…
