Singapore Issues Proposal for Unique Device Identification System
Singapore is planning to introduce a unique device identification (UDI) system for medical devices that is harmonized with the UDI approach developed by the International Medical Device Regulators Forum.
Singapore’s Health Sciences Authority (HAS) has issued a draft document on implementation plans for the new system that includes information on labeling requirements for UDIs and processes for submitting information.
The system will require UDIs in human readable and automated identification formats on device package labels and product identifier codes that include serial numbers, lot/batch numbers, software versions and manufacturing and expiration dates.
HSA is accepting comments on the proposed UDI system until June 30.