Government health authorities in Singapore have finalized regulatory guidelines on the manufacture, sale, and distribution of medical devices made using 3D-printing technology. The guidelines, first released in draft form earlier this year, are designed to ensure the products, which are increasingly used in Singapore, are safe and effective.
The guidelines were formulated by Singapore’s Health Sciences Authority (HSA) and refined after input from manufacturers.
3D-printing technology, also known as Additive Manufacturing (AM), uses digital modeling to build an object. It is increasingly employed to make custom prosthetics, dental devices, surgical tools, implantable devices, and other devices with complex, patient-specific designs. Current regulatory frameworks do not always apply to the process.
The new guidelines classify 3D-printed medical devices 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. They classify 3D-printed 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.
The guidelines confer the same regulatory status on 3D-printed devices as devices manufactured conventionally. That means they are subject to the same safety and risk principles.
The new guidelines do not apply to in-vitro diagnostics.