The China Food and Drug Administration (CFDA) has published new guidance into the registration requirements for 3D printed medical devices.
3D Printed ball
The draft guidance is intended to address industry questions into how the CFDA will approach the regulation for 3D-printed medical devices on the Chinese market.
The guidance covers 3D-printed implantable devices for orthopaedic and dental applications; biomaterials and pharmaceuticals produced using additive manufacturing.
The CFDA will also require validation testing for 3D printing manufacturing equipment and processes, as well as materials, software and final products.
Other key proposals of the guidance include environmental parameters which should include temperature, pressure, humidity, gas composition, printing speed, energy density and related factors.
The guidance also proposes that Product validations should include usability tests, that clinicians and healthcare professionals be involved in the design of 3D printed devices and that the use of 3D-printed medical implants should involve contracts between patients, manufacturers and healthcare providers.
It also states that additive manufacturers must conduct cleaning processes which may not be outsourced given the complexity of 3D printed medical devices.
The CFDA is awaiting comments from the industry and is aiming to issue a final version of the guidance to address the 3D printing sector.