- Blog
New Canada CARM System: Challenges for Clinical Trial Imports
6 Minutes
July 23, 2025
Last updated: May 12, 2026
Sponsors and CROs operating across borders may have recently encountered new and growing challenges when importing clinical trial materials into Canada.
Sponsors and CROs operating across borders may have recently encountered new and growing challenges when importing clinical trial materials into Canada. These challenges are closely tied to the recent rollout of the Canada Border Services Agency’s (CBSA) CBSA Assessment and Revenue Management (CARM) system. CARM compliance requires all commercial importers into Canada to be registered, introducing substantial procedural changes for organizations involved in global studies.
CARM compliance was introduced by the CBSA to manage commercial imports into Canada. CARM serves as the central platform for assessing and collecting duties and taxes on imported goods.
Imports are managed by the CARM system, particularly for non-resident entities, regulated product shipments, and logistics providers that have not yet adapted to the new requirements.
For clinical trials, the impact of these changes can extend well beyond customs documentation, affecting site readiness, drug availability, and even study viability.
A Changing Landscape for Clinical Imports
CARM was launched with the objective of modernizing and digitizing Canada’s import system. While the goal of CARM compliance is on efficiency and automation, the implementation has introduced new regulatory complexities.
The digitalization of Canada’s import system is especially relevant for sponsors managing clinical trial imports into Canada, including pharmaceuticals (particularly lab kits), investigational product logistics, and temperature-sensitive supply chains. Depending on device classification, importation may require a valid Medical Device Establishment License (MDEL) or prior approval from Health Canada.
Under this new CARM compliance framework, the requirements for acting as the Importer of Record (IOR) into Canada have become more stringent. Entities must ensure proper registration and system alignment, or risk clearance delays, including goods returned or even destroyed in customs.
The outcome of Canada’s CARM system can be costly for sponsors and may place significant strain on budgets and timelines for clinical trials in Canada.
The Effect of Canada’s CARM Compliance System on Non-Resident Importers
Historically, Canada’s Non-Resident Importer (NRI) program allowed foreign sponsors to act as Importer of Record (IOR) without needing a Canadian presence. This provided a practical approach to efficiently managing clinical logistics. However, under CARM compliance, even NRIs must now fulfill new obligations.
Many vendors who previously managed their own imports into Canada are unknowing to CARM compliance.
CARM Compliance and Risks for Clinical Trial
This shift has introduced new risks for studies that rely on outdated compliance approaches. In some instances, investigational products and critical study equipment have been delayed at customs, affecting activation timelines and compromising supply availability in Canada.
CARM compliance has raised complexities in the processes for both CROs and sponsors. Clinical trial sites are typically either unaware of the new requirements or unwilling to assume the additional reporting and financial responsibility.
Sponsors are unaware that ethics board approval in one country does not equate to authorization for importation to Canada. Without proper licensing, device shipments may be detained or rejected, regardless of their role in an approved protocol.
Medical Device Imports into Canada with CARM: Elevated Scrutiny
Regulatory Missteps Can Have a Costly Ripple Effect
In a highly regulated and time-sensitive environment, these risks carry significant weight. Ensuring that proper procedures are in place for Canadian imports is no longer optional; it is critical to the successful execution of studies.
TecEx Medical Can Help You Import Clinical Trials to Canada with the CARM System
TecEx Medical provides import CARM compliance support specifically tailored to the needs of the clinical research sector. Our team works with pharmaceutical sponsors, CROs, and clinical trial vendors to navigate complex regulatory environments with clarity and precision.
We help ensure that shipments reach their destination on time and in full compliance with Health Canada and CBSA requirements. Our clients rely on us for the seamless importation of investigational products, medical devices, lab equipment, and other regulated goods into Canada and other key markets.
If your organization is navigating import requirements under CARM or preparing for an upcoming study in Canada, TecEx Medical is here to help with CARM compliance. Our entity in Canada is, and continues to be, fully registered and licensed to act as a compliant Importer of Record (IOR), ensuring smooth and legally sound importation.
Who is required to register for CARM?
All commercial importers (resident and non-resident) must be registered under CARM.
What happens when you’re not registered under CARM?
Your shipment will NOT be cleared at the Canadian border.
Do USA importers need to register under CARM?
Yes, USA-based companies that import into Canada need an acting Importer of Record (IOR) or must independently register under CARM.
When are medical imports viable for CARM compliance?
CARM registration is mandatory for all importers; ALL commercial imports are viable for CARM registration.
Are clinical trial imports exempt from duties and taxes under CARM?
Clinical trial imports are NOT automatically exempt from duties and taxes under the CBSA’s CARM system.
