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Guidance on medical device establishment licensing (MDEL).: H14-334/2019E-PDF

"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.

Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.878679&sl=0

Publication information
Department/Agency
  • Canada. Health Canada, issuing body.
TitleGuidance on medical device establishment licensing (MDEL).
Variant title
  • Guidance on medical device establishment licensing (MDEL) (GUI-0016) version 8
Publication typeMonograph
Language[English]
Other language editions[French]
FormatDigital text
Electronic document
Note(s)
  • 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).
Publishing information
  • Ottawa, ON : Health Canada = Santé Canada, 2020.
  • ©2020
Description1 online resource (42 pages)
ISBN9780660324043
Catalogue number
  • H14-334/2019E-PDF
Subject terms
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