Health Canada has published guidance on the design and manufacturing, material controls, labelling and related issues for 3D-printed medical devices.
The guidance concerns companies with Class III and Class IV implantable devices produced via additive manufacturing.
In publishing the guidance, Health Canada said:
“Health Canada is committed to supporting the integration of 3D printed technologies into health care systems in Canada, and providing Canadians with the highest possible quality of care.
“The federal government is actively working and collaborating with international counterparts to keep pace with the research and development of 3D printing. Canada’s licensing approach for implantable medical devices manufactured by 3D printing is well aligned with international best practices.”
In addition, Health Canada also looked to the future of the technology environment for medical devices stating that this represents the ‘first phase’ of 3D-printing policy in Canada.
“Due to the fast-changing technological environment, Health Canada will continue to adapt its policy approach to 3D printing as issues on the topic evolve. This guidance document therefore represents the first phase of 3D printing policy in Canada.”
Read more from the guidance here.