Health Canada Medical Device Guidance: Terms and Conditions for Class II-IV Devices 

Health Canada has released a new guidance document outlining the use of Terms and Conditions (T&Cs) for Class II, III, and IV medical devices. Set to take effect on January 1, 2026, this framework establishes how Health Canada will impose, manage, and enforce T&Cs to ensure licensed medical devices continue to meet safety and effectiveness requirements under Sections 10–20 of the Medical Devices Regulations (MDR).  

Health Canada’s role in regulating medical devices is crucial for ensuring public health by fostering innovation while maintaining transparency, compliance, and enforcement throughout a device’s lifecycle. 

The new guidance also details the manufacturer’s obligations to ensure compliance with applicable requirements and maintain objective evidence of such compliance, including holding an amended authorization if their devices undergo specific changes affecting their classification or licensing. 

This article breaks down the key elements of the new guidance, what it means for medical device manufacturers, and how Dell Tech can help you stay compliant. 

What Are Terms and Conditions (T&Cs) for Medical Devices? 

Under Section 36 of the MDR, Health Canada has the authority to impose or amend terms and conditions on medical device licenses for Class II, III, and IV devices. These T&Cs are regulatory tools used to manage uncertainties, risks, and ongoing compliance through compliance and enforcement measures. The Minister may impose or amend T&Cs based on reasonable grounds, such as a belief that certain medical devices may not meet regulatory requirements or present a risk to public health. Medical device licence holders must comply with these terms and conditions to ensure their devices remain authorized for use.  

T&Cs help maintain post-market oversight, support risk mitigation, and enhance public health protection. The Minister may refuse a proposed amendment if it could lead to the device being unauthorized for certain medical conditions, emphasizing the importance of maintaining compliance with established regulations. 

Key Objectives of the Guidance Document 

• Provide a standardized framework for imposing or changing T&Cs on device licenses, specifying where the guidance document applies. 

• Ensure that devices continue to meet the same requirements for safety and effectiveness set by the MDR. 

• Emphasize the importance of clinical study data in regulatory decisions. 

• Improve transparency and communication between Health Canada and license holders. 

• Support post-market safety monitoring, enhanced by Vanessa’s Law (2014). 

• Highlight Health Canada’s ability to enhance oversight and assessment of medical devices through proposed regulations, ensuring proactive identification and addressing of issues during the product life cycle. 

• Effectively communicate risks to the public to ensure transparency and protect public health. 

Key Highlights of the Guidance? 

• T&Cs can be imposed or amended at any time on Class II–IV medical device licenses. 

• Health Canada must notify license holders and provide an opportunity for feedback before finalizing T&Cs.  

• T&Cs are designed to address uncertainties and support innovation in medical devices. 

• Compliance is mandatory, and non-compliance may result in license suspension or cancellation. 

• The Minister may refuse to amend an authorization if the proposed amendments could result in the device no longer being authorized for certain medical conditions. 

• Regulatory submissions must include requirements for the device referred, ensuring all manufacturing, labeling, and safety information is provided to address potential risks. 

Compliance and Enforcement 

Health Canada will actively monitor adherence to imposed T&Cs using: 

• Review of submitted documentation 

• Post-market surveillance 

• Inspection and audit results 

The licence holder is responsible for ensuring compliance with all regulatory terms and conditions. This includes maintaining up-to-date documentation, adhering to safety standards, and promptly addressing any issues identified during post-market surveillance or inspections. The same requirements must be continuously met to ensure ongoing compliance with established safety and effectiveness standards. Failure to comply may trigger regulatory actions ranging from warning letters to product recalls or market withdrawal. Non-compliance with these regulations, including the mishandling of confidential business information, may lead to enforcement measures, including fines and imprisonment, especially if there is a serious risk to human health associated with Class II, III, or IV medical devices. 

How Dell Tech Can Help Medical Device Companies 

Dell Tech Laboratories is a trusted regulatory partner with over 40 years of experience supporting manufacturers with: 

• Class II–IV medical device license applications 

• T&C interpretation and response strategy 

• Health Canada, FDA, and EU medical device submissions  

• Quality assurance support and regulatory compliance 

• Quality management system support 

We help you navigate changing regulatory requirements with confidence. 

Contact Dell Tech for Medical Device Regulatory Support 

Whether you need help with terms and conditions, device licensing, or post-market compliance for licensed medical devices, Dell Tech is here to support your business every step of the way. Our expertise includes navigating the regulatory landscape for medical devices to ensure quicker market entry.  

👉 Contact Us Today to speak with a regulatory consultant. 

DELL TECH HAS PROVIDED PROFESSIONAL, CONFIDENTIAL CONSULTING SERVICES TO THE SPECIALTY CHEMICAL INDUSTRY IN CANADA, THE USA, EUROPE AND ASIA FOR THE LAST 40 YEARS.