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Medical Device Establishment License (MDEL) Introduction
Class 1 medical device manufacturers must secure a Medical Device Establishment License (MDEL) if selling direct and not through a distributor. If you sell through distributors in Canada, and the distributor already has a Medical Device Establishment Licence, you do not need one. Class II,III and IV manufacturers do not require an MDEL.
Our GHTF Services Include:
We can help you to apply for your Medical Device Establishment License with Health Canada.
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