Health Canada is developing guidance to help devicemakers seeking to license 3D-printed medical devices.
Also called additive manufacturing, 3D printing is increasingly being used by hospitals to manufacture 3D-printed implanted medical devices. Hospitals that print such devices and distribute them beyond their institutions qualify as device manufacturers and as such must comply with the same regulatory obligations as other devicemakers, the agency said.
The 3D-printed devices are subject to the same pre- and post-market requirements as conventionally manufactured devices, but there are additional considerations such as patient-specific issues and software, the agency said.
The draft guidance will focus on pre-market Class III and Class IV applications for 3D implantable devices covered under ISO 13485.