Health Canada’s 2026 Terms & Conditions Update: What MedTech Companies Need to Know

Health Canada has recently issued guidance clarifying how it will apply Terms & Conditions (T&Cs) on Class II–IV medical device licenses, with the update coming into effect in January 2026. For Medtech companies planning to enter or operate in the Canadian market, understanding this update is critical for maintaining compliance and ensuring a smooth regulatory journey.

What Are Terms & Conditions?

T&Cs are specific obligations that Health Canada may attach to a medical device licence. While the authority to impose T&Cs has existed for some time under the Food and Drugs Act, this guidance explains how Health Canada intends to exercise that authority in practice. The goal is to provide companies with clear expectations for licensing, post-market surveillance, and risk management. The following are some examples of what medical device licence holders may be required to provide through T&Cs:

stability study results, such as real-time aging results
new evidence from post-market studies
performance data to confirm acceptable variations over time
clinical data collected from under-represented groups

for example, to assess impacts based on sex or gender

real-world evidence

for example, yearly submissions of sales and incident data in Canada or internationally

clinical study results, such as:

in select cases, long-term, ongoing follow-ups of clinical studies

The key implications for MedTech innovators is to actively monitor new information about the device’s real-world performance that creates uncertainty about whether the safety and effectiveness requirements of sections 10 to 20 of the MDR are still being met.

Why This Matters

By clarifying how T&Cs will be applied, Health Canada aims to make regulatory expectations more transparent and predictable. For manufacturers, this means fewer surprises and clearer pathways to compliance. However, it also places greater responsibility on companies to maintain vigilance and readiness across their device portfolios.

How Concept2Clinic Can Help

Navigating Health Canada’s regulatory landscape can be complex, especially when updates like this come into effect. At Concept2Clinic, we specialize in helping medtech companies:

Understand and interpret Health Canada guidance
Ensure device licensing and importation compliance
Implement robust post-market and risk management processes

Our team acts as your outsourced regulatory partner in Canada, helping you anticipate regulatory requirements, respond promptly to Health Canada requests, and streamline your entry into the Canadian market.

With the January 2026 T&C guidance approaching, now is the time to review your licensing and compliance processes. Staying ahead ensures your devices remain compliant, your market access is uninterrupted, and your focus remains on delivering innovative solutions to Canadian patients.