00000nam 2200000zi 4500 9.878679 CaOODSP 20221107165316 m o d f cr cn||||||||| 190829t20202020onca ob f000 0 eng d 9780660324043 CaOODSP eng rda CaOODSP n-cn--- H14-334/2019E-PDF Guidance on medical device establishment licensing (MDEL). Guidance on medical device establishment licensing (MDEL) (GUI-0016) version 8 Ottawa, ON : Health Canada = Santé Canada, 2020. ©2020 1 online resource (42 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier Issued also in French under title: Document d'orientation concernant l'octroi d'une licence d'établissement d'instruments médicaux (LEIM). "GUI-0016." "April 1, 2020." "Pub.: 190319." Issued also in HTML format. Includes bibliographical references (pages 39-41). "This guidance document is intended for any person in the medical device industry and it provides guidance on regulatory requirements in relation to Medical Device Establishment Licences (MDEL), including when and how to apply for an MDEL, and how to maintain an MDEL once issued. This guidance document does not cover importing medical devices for personal use or for use on animals"--Purpose, page 6. Medical instruments and apparatus industry Licenses Canada. Canada. Health Canada, issuing body. Document d'orientation concernant l'octroi d'une licence d'établissement d'instruments médicaux (LEIM). (CaOODSP)9.878680 PDF 734 KB https://publications.gc.ca/collections/collection_2020/sc-hc/H14-334-2019-eng.pdf HTML N/A https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/guidance-medical-device-establishment-licensing-0016/document.html