Notice: Publication of the Guidance Document: Supporting Evidence for Implantable Medical Devices Manufactured by 3D Printing

April 30, 2019

Our file number: 19-105025-325

Health Canada is pleased to announce the finalization of the Guidance Document: Supporting Evidence for Implantable Medical Devices Manufactured by 3D Printing. This guidance document is intended to aid manufacturers and regulatory representatives in preparing medical device licence applications for implantable 3D-printed medical devices.

The draft version of this document was posted to the Health Canada website on November 8, 2018 for a 60-day consultation. Stakeholder comments received on the draft version of this document were considered in the finalization of this guidance document. A summary of comments received is available upon request.

This guidance document is effective immediately.

Questions or concerns regarding this guidance document should be directed to:

Device Licensing Services Division
Medical Devices Bureau
Therapeutic Products Directorate
Health Canada
11 Holland Avenue
Address Locator: 3002A
Ottawa, Ontario
K1A 0K9

Email: device_licensing@hc-sc.gc.ca
Telephone: 613-957-7285
Fax Number: 613-957-6345

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