#device vigilance

From the desk of TGA- June 22, 2021 TGA has revised its guidance on 3D-printed devices to feature changes that reflect the new regulatory framework and updates to the legislation. This is the third version of the guidance. The new guidance starts with a history of the regulation of personalized medical devices in Australia, before going on to explain the definitions established by the new rules.…

3D Printing of Medical Devices

Additive manufacturing is an official industry standard term (ASTM F2792) for the process of joining materials to make objects from 3D model data, usually layer upon layer, as opposed to subtractive manufacturing methodologies.

3D printing is a type of additive manufacturing, process that creates a three-dimensional object by building successive layers of raw material. Each new layer is…