Singapore Drafts Guidelines for Regulation of 3D-Printed Medical Devices

With the use of 3D-printed medical devices expanding rapidly in Singapore, government health authorities have released a set of guidelines for their regulation.

Released in draft form in late January by Singapore’s Health Sciences Authority (HSA), the guidelines are designed to ensure that devices manufactured using 3D printing technology are safe and effective, officials say. Manufacturers were invited to submit input and seek clarification on the guidelines during the month of February.

3D printing technology is increasingly employed to make custom prosthetics and other devices with complex, patient-specific designs, but current regulatory frameworks do not always apply to it. As drafted, the new guidelines will classify 3D-printed medical devices as “mass-produced” if they are manufactured in batches and use a common design, even if the device is matched for use by a specific patient. Devices will be classified as “custom-made” if they are made at the request of a practitioner in accordance with unique design specifications, and if they are based on the physical and pathological characteristics of a specific patient.

The draft guidelines do not apply to in-vitro diagnostics.