
Medical Device Establishment License
To manufacture, import, or distribute medical devices in Canada, you will need a Medical Device Establishment License (MDEL).
Establishment Registration
Domestic and foreign manufacturers, distributors, or importers of medical devices in USA must register their establishment with FDA.
Suspension of an Establishment Licence
Your establishment license will be suspended if you fail to comply with regulations, ‘present misleading statements’ in the application.
FDA Inspection
Every medical device manufacturing facility undergoes FDA inspection to ensure compliance with QS requirements.