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  MDEL Services Include:

We can help you to apply for your Medical Device Establishment License with Health Canada.