Health Canada, a Federal institution of the Government of Canada responsible for helping Canadians maintain and improve their health has issued draft guidance document to aid manufacturers in preparing license for implantable medical devices manufactured using 3D printing.
The guidance document is intended to aid manufacturers and regulatory representatives in preparing medical device licence applications for 3D-printed medical devices.
The policy guidance comes as a result of fast-changing technological environment and as a move by Health Canada to adapt its policy approach to the continuously evolving 3D printing technology. The guidance is thus being represented as the first phase of 3D printing policy in Canada.
According to the draft guidance, hospitals that manufacture 3D-printed implantable medical devices for distribution beyond their institution qualify as manufacturers and have the same obligations as other medical device manufacturers.
As per the draft guidance, 3D printed medical devices are subject to certain data requirements in addition to those that are applicable to medical devices manufactured using traditional manufacturing methods. The draft guidance also offers considerations for device designs and manufacturing process. For example, as per the guidance document issued by Health Canada, “devices produced by additive manufacturing, or 3D printing, are subject to the Medical Devices Regulations (Regulations) and require a review of submitted evidence of safety and effectiveness before a licence can be issued”.
As per the device description policies, manufacturers need to state whether 3D printing was used to produce only a part of the component or to produce the device in entirety. In addition, when 3D printing patient-specific devices, manufacturers will also have to provide additional descriptors such as the location and thickness of porous features.
The draft guidance is now open for consultation to seek stakeholder feedback on the technical considerations outlined in the draft guidance document until 8 January, 2019.