Health Canada Drafts Policies on 3D-Printed Implantable Devices
Posted 09 November 2018 | By
Health Canada released draft guidance Thursday to aid manufacturers in preparing license applications for implantable medical devices produced by additive manufacturing or 3D-printing.
The guidance “represents the first phase of 3D-printing policy in Canada” because Health Canada intends to continuously adapt its policies to emerging issues on the topic “due to the fast-changing technological environment,” the regulator said.
3D-printed medical devices may be subject to certain data requirements in addition to those that apply to conventionally manufactured medical devices, according to the draft guidance. It includes considerations for device designs and manufacturing processes, as well as policies on material controls, device testing and labeling on 3D-printed implantable medical devices.
The policies are intended to provide clarifications on what agency review staff would expect to be included as part of a complete premarket Class III and Class IV license application for a 3D-printed implantable medical device in accordance with ISO 13485. Definitions in the guidance document were developed via the International Medical Device Regulators Forum.
Under device description policies, the draft guidance calls for stating whether the entirety of or a component of a device is 3D-printed. Additional descriptors should be included for a device that is manufactured to be patient-specific, such as the location and thickness of porous features.
“Hospitals that manufacture 3D-printed implantable medical devices for distribution beyond their institution qualify as a manufacturer, and should comply with the same obligations as other medical device manufacturers,” Health Canada clarified.
The consultation for stakeholders to provide feedback on the technical considerations outlined in the draft guidance document will remain open until 8 January 2019.
Consultation on the Draft Guidance Document: Licensing Requirements for Implantable Medical Devices Manufactured by 3D Printing