Health Canada Regulatory Solutions  

The main objective of this module is to provide our clients with the services they need to comply with the various Health Canada regulations as needed. 

Consulting services available within this module are:

  • Health Canada Medical Device Classification

  • Health Canada Medical Device Licensing (MDL)

  • Health Canada Medical Device Establishment Licensing (MDEL)

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Health Canada Medical Device Classification

What is the Health Canada medical device class for your medical device(s)? 

How have you confirmed the accuracy of this information?  

Sometimes MD&D manufacturers can assume that the Health Canada medical device class for their product(s) will be similar to that in the USA or Western Europe. This can result in significant avoidable costs, delays, liability exposure, and business disruption.  

The fact is that Health Canada classifies medical devices independently of other jurisdictions. Therefore, as a manufacturer, it is crucial to accurately classify your medical devices specific to Health Canada rules and regulations. 

To provide you with the maximum possible certainty, we offer our professional services to interpret your device information, apply Health Canada rules, recommend a device classification, and facilitate a formal classification ruling for medical devices directly from Health Canada.    

Health Canada Medical Device Licensing (MDL)

Does your medical device require a Health Canada Medical Device License (MDL)? For which device class? 

As per Health Canada, medical devices are classified into one of four classes by means of classification rules, where Class I represents the lowest risk and Class IV represents the highest risk. Class II, III and IV medical devices must be licensed prior to importation or sale in Canada. A license is issued to the device manufacturer for each application submitted, provided the requirements of the Medical Devices Regulations (MDR) are met. 

We manage the entire application process for Class II, III, or IV Health Canada medical device licenses (MDL). This includes a comprehensive review of the medical device information, a gap analysis vs. Health Canada requirements, preparation of application package, submission, facilitating responses to any Health Canada questions, and finally the MDL issuance and subsequent maintenance. 

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Health Canada Medical Device Establishment Licensing (MDEL)

Do you need a Health Canada Medical Device Establishment License (MDEL)? For which device classes and activities? 

As per Health Canada, any person who imports into Canada, or sells in Canada, a medical device for human use requires an establishment license (some exceptions apply). 

We manage the entire application process for Health Canada medical device establishment licenses (MDEL) right up to the MDEL issuance on behalf of our clients. This includes but is not limited to developing the required standard operating procedures (SOPs), reviewing existing SOPs, a gap analysis vs. Health Canada requirements, preparation of application package, submission, facilitating responses to any Health Canada questions, and finally the MDEL issuance and subsequent maintenance.

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