Guidance on Medical Device Establishment Licensing (GUI-0016)

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.

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Additional Info

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Agreement Required
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Title (French) Orientation concernant l’octroi d’une licence d’établissement d’instruments médicaux (GUI-0016)
Update Frequency as_needed
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Sensitivity Level unrestricted
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Data Dictionary
Open Canada Date Published 2022-10-04 00:00:00
Open Canada Date Modified
Open Canada Subject ["health_and_safety"]
Open Canada Keywords {"fr": ["GUI-0016", "exigences réglementaires", "licence d'établissement d'instruments médicaux", "LEIM"], "en": ["GUI-0016", "regulatory requirements", "medical-device", "establishment licence", "MDEL"]}
Open Canada Collection publication
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