FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

Health Canada Issues Final Guidance on 3D-Printed Implantable Devices

May 14, 2019
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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.

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