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.

Data and Resources

Additional Info

Field Value
Source
Version
Author
Author Email
Maintainer
Maintainer Email
Data Level
Agreement Required
Purpose Constraints
Redistribution Allowed
AI Training Allowed
Data Steward
Title (French) Orientation concernant l’octroi d’une licence d’établissement d’instruments médicaux (GUI-0016)
Update Frequency as_needed
Geographic Scope []
Criticality Level []
Sensitivity Level unrestricted
Language
Contact Person
Contact Email
Data Dictionary
Open Canada Date Published 2020-03-01 00:00:00
Open Canada Date Modified
Open Canada Subject ["health_and_safety"]
Open Canada Keywords {"fr": ["Orientation concernant l’octroi d’une licence d’établissement d’instruments médicaux", "industrie des instruments médicaux", "exigences réglementaires en lien avec une licence d’établissement d’instruments médicaux"], "en": ["Guidance on Medical Device Establishment Licensing", "medical device industry", "regulatory requirements of Medical Device."]}
Open Canada Collection publication
Principal Organization
Reference Data
Official Source