![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » Health Canada Issues Final Guidance on 3D-Printed Implantable Devices
Health Canada Issues Final Guidance on 3D-Printed Implantable Devices
May 13, 2019
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.
Upcoming Events
-
21Oct