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Health Sciences Authority
Regulatory Updates

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

Audiences

Healthcare professional

Industry member

Product type

Medical devices

25 May 2021

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

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) [PDF, 924 KB] (opens in new tab)

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 (opens in new tab) by 30 June 2021. Please indicate "Guidance on the Medical Device UDI System" in Question 6 of the form.

guidance-feedback-form14 KB [XLSX, 15 KB] (opens in new tab)