Towards Providing Patient Quality Care
Health Canada, a department of the Canadian government, is committed to supporting the integration of 3D printed technologies into health care systems in the country, hence, providing Canadians with the highest possible quality of care.
Health Canada has issued new guidance for the 3D printing of medical devices. The guidelines aim to give the proper and required information for the manufacture of moderate to high risk devices, including orthopedic implants, and pacemakers. It has been deemed the “first phase” policy for the country.
After several revisions since its first draft in November 2018, it has now been published as Guidance Document – Supporting Evidence for Implantable Medical Devices Manufactured by 3D Printing.
It’s quite a comprehensive document that informs 3D manufacturers about the standard information required for conventionally made medical devices, that the 3D printed products should have an overview of the 3D printing process, key device design parameters, design parameters altered to meet patient-matched specifications, and a description of critical features. It should also have a Medical Device License (MDL) application. It is imperative that all manufacturers should have undergone Health Canada preclinical performance testing for the devices and give overviews of the software-related workflows used. And for some clinical devices, clinical data is also needed when utilizing novel designs, materials or intended uses.
The guidelines are intended for any Class III (moderate risk) and Class IV (high risk) medical devices made using 3D printing, and do not cover the production of anatomical models, standalone software, 3D bio-printed objects, or patient-specific devices. Patient-specific devices require a separate classification on an as-needs basis. The guidelines are also applicable to the volume production of 3D printed medical devices that have an equivalent already on the market, e.g. spine implants, hip cups and stents.
Health Canada realizes that due to the fast-changing technological pace in 3D printing and its growing accepted usage, it will continue adapting its policy approach to 3D printing as issues evolve.