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008190326t20192019onc     ob   f000 0 eng d
020 |a9780660302812
040 |aCaOODSP|beng|erda|cCaOODSP
043 |an-cn---
0861 |aH164-274/2019E-PDF
24500|aGuidance document : |bsupporting evidence for implantable medical devices manufactured by 3D printing.
264 1|aOttawa, ON : |bHealth Canada = Santé Canada, |c2019.
264 4|c©2019
300 |a1 online resource (18 pages)
336 |atext|btxt|2rdacontent
337 |acomputer|bc|2rdamedia
338 |aonline resource|bcr|2rdacarrier
500 |aIssued also in French under title: Ligne directrice : données sur les instruments médicaux implantables fabriqués par impression 3D.
500 |aCover title.
500 |a"Date adopted: 2019/04/30. Effective date: 2019/04/30."
500 |a"Publication date: April 2019."
500 |a"Pub.: 180937."
500 |aIssued also in HTML format.
504 |aIncludes bibliographical references.
520 |a"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.
69207|2gccst|aMedical products
7101 |aCanada. |bHealth Canada.
77508|tLigne directrice : |w(CaOODSP)9.870632
85640|qPDF|s496 KB|uhttps://publications.gc.ca/collections/collection_2019/sc-hc/H164-274-2019-eng.pdf
8564 |qHTML|sN/A|uhttps://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/3d-licensing-requirements/document.html