00000nam 2200000zi 4500 9.870631 CaOODSP 20221107163153 m o d f cr cn||||||||| 190326t20192019onc ob f000 0 eng d 9780660302812 CaOODSP eng rda CaOODSP n-cn--- H164-274/2019E-PDF Guidance document : supporting evidence for implantable medical devices manufactured by 3D printing. Ottawa, ON : Health Canada = Santé Canada, 2019. ©2019 1 online resource (18 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier Issued also in French under title: Ligne directrice : données sur les instruments médicaux implantables fabriqués par impression 3D. Cover title. "Date adopted: 2019/04/30. Effective date: 2019/04/30." "Publication date: April 2019." "Pub.: 180937." Issued also in HTML format. Includes bibliographical references. "This guidance document is intended to aid manufacturers and regulatory representatives in preparing medical device licence applications for 3D printed medical devices. As with all Class III and IV medical devices, devices produced by additive manufacturing or 3D printing, are subject to the Medical Devices Regulations (Regulations) and require a review of submitted evidence of safety and effectiveness before a licence can be issued. This guidance document should be read in conjunction with the Guidance Document on supporting evidence to be provided for new and amended licence applications for Class III and Class IV medical devices, not including In Vitro Diagnostic Devices (IVDDs)"--Introduction, page 5. gccst Medical products Canada. Health Canada. Ligne directrice : (CaOODSP)9.870632 PDF 496 KB https://publications.gc.ca/collections/collection_2019/sc-hc/H164-274-2019-eng.pdf HTML N/A https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/3d-licensing-requirements/document.html