Guidance Document – Supporting Evidence for Implantable Medical Devices Manufactured by 3D Printing - Summary
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Overview
This guidance document is intended to aid manufacturers and regulatory representatives in preparing medical device licence applications for 3D-printed medical devices.
Who this guide is for
Medical Device manufacturers
In this guide
- 1. Introduction
- 1.1 Overview
- 1.2 Scope and application
- 1.3 Policy objectives
- 1.4 Policy statements
- 1.5 Background
- 2. Guidance for implementation
- 3. Contact Information
- 4. Appendices
Download PDF (271 KB, 18 pages)
Details and history
Published: April 30, 2019
Consulted: November 8, 2018 - January 8, 2019
Part of topic(s): Guidance on legislation, medical devices and 3D printing
For assistance
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By email: devicelicensing-homologationinstruments@hc-sc.gc.ca
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