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Original Data
Modernizing the Medical Device Establishment Licensing (MDEL) Framework
Record Modified: Feb 27, 2023
Record Released: Feb 27, 2023
Publisher: Health Canada
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HTML
Keywords:
MDEL
MDEL framework
modernizing MDEL
regulatory plan
enabling act
Similar Data
Health Canada issues Medical Device Establishment Licences (MDELs) to companies that import, distribute or manufacture Class I devices, and importers …
Record Modified: Apr 30, 2021
Record Released: Apr 30, 2021
Publisher: Health Canada
Formats:
HTML
Keywords:
COVID-19
guidance
Medical Device Establishment Licence (MDEL)
suspensions
What Medical Device Establishment Licence (MDEL) holders need to know about annual licence review for 2023
Record Modified: Feb 27, 2023
Record Released: Feb 27, 2023
Publisher: Health Canada
Formats:
HTML
Keywords:
An annual licence review (ALR) ensures that MDEL holders are complying with the regulatory requirements.
This guidance document is intended for any person in the medical device industry and it provides guidance on regulatory requirements …
Record Modified: Feb 27, 2023
Record Released: Feb 27, 2023
Publisher: Health Canada
Formats:
HTML
Keywords:
GUI-0016
regulatory requirements
medical-device
establishment licence
MDEL
This document provides guidance on regulatory requirements in relation to medical device establishment licence (MDEL), such as when and how …
Record Modified: Feb 27, 2023
Record Released: Feb 27, 2023
Publisher: Health Canada
Formats:
HTML
Keywords:
GUI-0016
regulatory requirements
medical-device establishment licence
MDEL
An annual licence review (ALR) ensures that MDEL holders are complying with the regulatory requirements.
Record Modified: Feb 27, 2023
Record Released: Feb 27, 2023
Publisher: Health Canada
Formats:
HTML
Keywords:
MDEL
MDEL holders
annual licence review
complying with regulatory-requirements