Guidance on Medical Device Establishment Licensing (GUI-0016) - Summary

Name: Guidance on Medical Device Establishment Licensing (GUI-0016) - Summary
Creator: Health Canada
License: https://open.canada.ca/en/open-government-licence-canada

This document provides guidance on regulatory requirements in relation to medical device establishment licence (MDEL), such as when and how to apply for an MDEL, as well as how to maintain it once it is issued.