Canada Issues Draft Guidance on 3D Printing for Implantable Devices

Health Canada issued draft guidance for devicemakers on preparing applications for 3D-printed implantable devices.

The guidance covers the evidence required to support pre-market Class III and Class IV licenses applications for implantable devices manufactured by 3D printing under ISO 13485. The guidance also covers design and manufacturing processes, material controls, device testing and labeling of 3D devices.

Class III and IV medical devices by additive manufacturing are subject to the Medical Device Regulations and “require a review of submitted evidence of safety and effectiveness before a license can be issued,” the agency said.