Singapore HSA Publishes Regulatory Guideline for 3D-Printed Medical Devices

On 15th July 2021, HSA has finalised the Regulatory Guideline for 3D-printed medical devices. A separate FAQ has been compiled to further clarify on specific queries highlighted during the consultation that took place from 25th July to 28 February 2021.

Medical devices manufactured using 3D printing technology are subject to the current regulatory framework and requirements as those manufactured using traditional manufacturing techniques, based on risk classification of the device.

3D-printed medical devices must comply with the Essential Principles of Safety and Performance as described in GN-16: Guidance on Essential Principles for Safety and Performance of Medical Devices.

Unlike custom made medical devices, all Class B, C and D patient-matched medical devices are required to be registered on Singapore Medical Device Register (SMDR). Companies supplying patient-matched medical devices locally should submit their product registration application to HSA by 01 August 2022 to continue supplying their devices in Singapore.

Link to Regulatory Guidelines:

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