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Health Sciences Authority
Regulatory Updates

Consultation on Regulatory Guidelines for 3D Printed Medical Devices

Audiences

Healthcare professional

Industry member

Product type

Medical devices

25 January 2021

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

[Updated on 25 January 2021]

The Medical Devices Branch (MDB) has published a draft document "Regulatory Guidelines for 3D Printed Medical Devices" for comments. This document intends to provide clarity on the current regulatory requirements for 3D printed medical devices. We would like to invite our stakeholders to provide feedback on this document:

Guidelines on 3DP Medical Devices [PDF, 520 KB] (opens in new tab)

The Consultation period for this document is from 25 January 2021 to 28 February 2021. Please email your feedback using the prescribed feedback form to HSA_MD_INFO@hsa.gov.sg (opens in new tab) by 28 February 2021. Please indicate "Regulatory Guidelines for 3D Printed Medical Devices" in the email subject header.

Guidance Feedback Form14 KB [XLSX, 15 KB] (opens in new tab)