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How do I go about getting a Medical Device Establishment Licence (MDEL) from Health Canada?

After determining that you are required to get a medical device establishment licence (MDEL) the best place to start is by visiting TPD’s webpage. You will find useful answers to most of your questions. 

When it comes to actually filling out the forms and obtaining guidance documents you will need the following:

Guidance on Medical Device Establishment Licensing

Medical Device Compliance and Enforcement Directive  Contains clear description of compliance and enforcement actions relating to the Medical Devices Regulations (Regulations) and sections of the Food and Drugs Act (Act) applicable to medical devices.

• Guidance on Medical Device Inspection Programme

• Medical Devices Establishment Licence Application Form

• Inspection strategy for Medical Device Companies

• Medical Device Establishment Licence Fee Reduction