Canada: Health Canada provides Guidance on 3D printed implantable devices

02-05-2019

Canada: Health Canada provides Guidance on 3D printed implantable devices

(Source: RAPS 2019-05-03)

Health Canada on Tuesday unveiled new guidance discussing what evidence is required to support pre-market Class III and Class IV license applications for implantable medical devices manufactured via 3D printing.

While making distinctions between patient-matched 3D printed devices and devices manufactured to prespecified sizes, the guidance explains everything from how the devices should be designed to what preclinical and clinical studies should be run, in addition to shelf life considerations.

“As part of the evidence to demonstrate the safety and effectiveness of a Class III or IV 3D printed device, manufacturers should submit the additional information outlined in this guidance document with their application,” Health Canada says.

To continue reading this article please go to RAPS

New Article