Consultation for Guidance on the Medical Device Unique Device Identification (UDI) System

The Medical Devices Branch (MDB) has published a draft document "Guidance on the Medical Device Unique Device Identification (UDI) System" for comments. This document is intended to provide clarity on the regulatory requirements for Unique Device Identification (UDI) implementation in Singapore and the details on the steps to submit UDI information into the Singapore Medical Device Register (SMDR) and Class A Medical Device Database. We would like to invite our stakeholders to provide feedback on this document:

For Consult Guidance on UDI System (25May_pub)923 KB

The Consultation period for this document is from 25 May 2021 to 30 June 2021. Please submit your feedback using the prescribed guidance feedback form via our online UDI enquiry form by 30 June 2021. Please indicate "Guidance on the Medical Device UDI System" in Question 6 of the form.

guidance-feedback-form14 KB

Published: 25 May 2021

Regulatory Updates