Health Canada issued final guidance for devicemakers on supporting evidence required for submitting applications for 3D-printed implantable devices.
In response to comments on the agency’s November 2018 draft, the final guidance makes the distinction between patient-specific devices with patient-matched devices, to align with the International Medical Device Regulators Forum (IMDRF)’s definitions for personalized medical devices.
The updated guidance covers the evidence required to support pre-market Class III and Class IV license applications for implantable devices manufactured by 3D printing.
