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
| Department/Agency | Canada. Health Canada, issuing body. |
|---|---|
| Title | Guidance on medical device establishment licensing (MDEL). |
| Variant title | Guidance on medical device establishment licensing (MDEL) (GUI-0016) version 8 |
| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Format | Electronic |
| 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 |
| Description | 1 online resource (42 pages) |
| ISBN | 9780660324043 |
| Catalogue number |
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| Subject terms | Medical instruments and apparatus industry -- Licenses -- Canada. |
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