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]
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.