- Blog
New Canada CARM System: Challenges for Clinical Trial Imports
6 Minutes
July 23, 2025
Last updated: November 18, 2025
Sponsors and CROs operating across borders may have recently encountered new and growing challenges when importing clinical trial materials into
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) Canadian Assessment and Revenue Management (CARM) system, which has introduced substantial procedural changes for organizations involved in global studies.
CARM is reshaping how imports are managed, 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 its goals focus on efficiency and automation, the implementation has introduced new regulatory complexities. These developments are especially relevant for sponsors managing pharmaceutical imports (particularly lab kits), investigational product logistics, and temperature-sensitive supply chains.
Under this new framework, the requirements for acting as Importer of Record (IOR) have become more stringent. Entities must ensure proper registration and system alignment, or risk facing avoidable clearance delays such as the goods being returned to sender – or worse – destroyed in customs. These outcomes can be costly for Sponsors and may place significant strain on clinical trial budgets and timelines.
The Effect of Canada’s CARM 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 offered a practical route to manage clinical logistics efficiently. However, under CARM, even NRIs must now fulfill new obligations. Many vendors who previously managed their own imports have not yet met these standards.
This shift has introduced new risk exposure for studies relying on outdated compliance approaches.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.
Medical Device Imports into Canada with CARM: Elevated Scrutiny
Clinical trials involving devices must also account for Canada’s distinct regulatory requirements. Depending on device classification, importation may require a valid Medical Device Establishment License (MDEL) or prior approval from Health Canada.
Clinical trial sites are typically either not aware of these requirements, or unwilling to take on this additional reporting and financial responsibility, adding complexity for sponsors and CROs attempting to get medical devices into Canada.
Many 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.
In a highly regulated and time-sensitive environment, these risks carry significant weight. Ensuring proper procedures are in place for Canadian imports is no longer optional; it is critical to successful study execution.
Working With TecEx Medical
TecEx Medical provides import 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. 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.
Connect with our team to ensure your trial logistics are fully compliant and aligned with your study timeline.
