On April 1, 2026, Health Canada released the updated Guidance on Terms and Conditions for Class II to IV Medical Devices, which took effect immediately. This guidance follows the expansion of the Terms and Conditions (T&Cs) authority under the Medical Devices Regulations (MDR) on January 1, 2026, marking another significant step toward a lifecycle-based regulatory framework for medical devices in Canada.
What exactly are T&Cs? What does it mean if additional terms are attached to a Medical Device Licence (MDL)? How will these changes affect manufacturers planning to enter or expand in the Canadian market? This article provides an overview of the new regulatory framework.
1. What Are Terms and Conditions (T&Cs)?
Terms and Conditions (T&Cs) are regulatory requirements that Health Canada may impose on or amend within a Class II, III, or IV Medical Device Licence (MDL).
In practice, T&Cs allow Health Canada to exercise continuous regulatory oversight throughout a device’s lifecycle, ensuring that licensed medical devices continue to meet the safety and effectiveness requirements set out in Sections 10–20 of the Medical Devices Regulations.
2. Regulatory Background: Why Were T&Cs Expanded?
Canada’s enhanced post-market regulatory authority originated with Vanessa’s Law (Protecting Canadians from Unsafe Drugs Act), enacted in 2014. The legislation strengthened Health Canada’s authority to collect post-market safety information and empowered the Minister of Health to take action when significant health risks are identified.
Building on this framework, amendments to Section 36(2) of the Medical Devices Regulations expanded the scope of T&Cs. The amendments took effect on January 1, 2026, enabling the Minister to impose or amend licence conditions at any point during the lifecycle of a medical device.
The updated guidance issued on April 1, 2026, further clarifies the scope, implementation process, and regulatory expectations for T&Cs.
3. T&Cs at a Glance
| Category | Details |
|---|---|
| Legal Basis | Medical Devices Regulations Section 36(2); Vanessa’s Law |
| Applicable Devices | Class II, III and IV Medical Device Licences (MDLs) |
| Effective Dates | Regulatory amendments: January 1, 2026; Updated guidance: April 1, 2026 |
| Authority | The Minister may impose or amend T&Cs at any stage of the device lifecycle |
| Procedural Requirement | Licence holders must be notified and given an opportunity to provide comments before T&Cs are imposed or amended |
| Regulatory Objective | Lifecycle oversight, management of uncertainties associated with innovative devices, and continuous regulatory compliance |
4. What Can Health Canada Require Under T&Cs?
According to the updated guidance, Health Canada may require licence holders to provide various types of post-market evidence, including:
- Stability study results (e.g., real-time aging data)
- New evidence generated through post-market studies
- Device performance data collected over time
- Clinical evidence from underrepresented populations (including sex- and gender-based analyses)
- Real-world evidence, such as annual sales data and adverse event reports from Canada or international markets
- Long-term clinical follow-up study results
In essence, T&Cs enable Health Canada to tailor additional post-market obligations to individual devices in order to address ongoing uncertainties and emerging risks.
5. Three Major Regulatory Changes
1) Dynamic Regulatory Authority
Health Canada may now impose or revise T&Cs at any stage of a medical device’s lifecycle, from initial licensing through post-market surveillance. T&Cs are no longer static licence conditions but have become an adaptive regulatory tool.
2) Broader Scope of Application
The updated framework expands the circumstances in which T&Cs may be used, particularly for innovative technologies where long-term evidence continues to evolve after commercialization.
3) Stronger Post-Market Oversight
Health Canada will actively monitor compliance with T&Cs through document reviews, post-market surveillance activities, inspections, and audits. Manufacturers are expected to continuously demonstrate compliance rather than relying solely on initial market authorization.
6. Other Key Regulatory Developments (2025–2026)
Mandatory REP Electronic Submission
Beginning January 2026, all Class II–IV MDL applications must be submitted through the Regulatory Enrolment Process (REP) using the Common Electronic Submission Gateway (CESG). Email submissions are no longer accepted.
Updated MDL Application Management Guidance
The revised Guidance on Managing Applications for Medical Device Licences took effect on February 2, 2026, introducing enhanced screening procedures and stricter timelines for responding to information requests.
Adoption of the IMDRF Table of Contents
In November 2025, Health Canada formally adopted the International Medical Device Regulators Forum (IMDRF) Table of Contents format for medical device applications, promoting greater alignment with other major regulatory jurisdictions.
MDEL Phase II Reform
Public consultation on the second phase of the Medical Device Establishment Licence (MDEL) reform concluded on January 17, 2026. Proposed changes include eliminating mandatory MDEL requirements for foreign distributors while introducing additional supplier listing obligations.
7. Recommendations for Medical Device Manufacturers
Strengthen MDL Application Readiness
Manufacturers should:
- Obtain MDSAP certification as early as possible.
- Prepare technical documentation using the IMDRF Table of Contents structure.
- Complete REP account registration and validate CESG submission capability before filing applications.
Build an Ongoing T&C Compliance System
Manufacturers should establish internal procedures to:
- Monitor licence conditions continuously.
- Integrate T&C obligations into their quality management system.
- Maintain evidence supporting ongoing compliance throughout the product lifecycle.
T&C-related activities should also be incorporated into annual MDSAP surveillance audits where applicable.
Ensure Supply Chain Compliance
Foreign manufacturers marketing medical devices in Canada must continue working with Canadian importers holding valid Medical Device Establishment Licences (MDELs). Although proposed reforms may remove mandatory MDEL requirements for foreign distributors, manufacturers remain responsible for ensuring their Canadian import partners maintain regulatory compliance.
Conclusion
Canada’s medical device regulatory system is shifting from a traditional pre-market approval model toward a risk-based, lifecycle-oriented regulatory framework.
The expanded T&Cs authority reflects Health Canada’s expectation that manufacturers demonstrate continuous compliance, rather than one-time regulatory approval.
Manufacturers preparing for the Canadian market should prioritize:
- Obtaining MDSAP certification;
- Upgrading technical documentation to align with the IMDRF Table of Contents;
- Preparing for mandatory REP/CESG electronic submissions;
- Establishing robust post-market surveillance and T&C compliance processes.
Early preparation will help manufacturers adapt efficiently to Canada’s evolving regulatory landscape and maintain long-term market access.