- Blog
Who is Responsible for Importing Clinical Trial Materials?
5 Minutes
September 1, 2026
The entity that acts as the Importer of Record (IOR) depends on who can bear legal, financial, and regulatory accountability.
Before importing clinical trial materials globally, every trial operator must consider complex regulatory compliance, strict import-export licensing, specialized cold-chain logistics, and customs clearance procedures. Under government and customs authority laws, a designated Importer of Record (IOR), who is responsible for importing clinical trial materials, must be appointed to assume legal responsibility for a medical shipment.
Who is responsible for importing clinical trial materials largely depends on the entity that bears legal, financial, and regulatory accountability for the shipment. They must ensure compliance with local customs laws, pay all tariffs and taxes, and guarantee the safety and legality of the medical products entering the country.
Not everyone involved in a global clinical trial shipment can act as the IOR. While various parties, such as consignees, freight forwarders, and brokers, play important roles, only a registered local entity or its appointed IOR partner can legally assume this responsibility.
Can the Sponsor be the Importer of Record?
The pharmaceutical company or institution running the study can act as its own IOR. This arrangement is generally applicable where the sponsor’s local subsidiary or affiliate maintains a physical office in the destination country. Under such circumstances, the sponsor assumes full responsibility for the associated risks and functions as the IOR for the duration of the study shipment timeline.
However, this extended role adds complexity for the sponsor that can impact the trial. These usually include classification issues and the lack of relevant licenses. This overexposes the shipment, delays it, or causes holdups in customs.
An issue we continuously see Sponsors face is realizing too late that they spent money on VAT they weren’t meant to pay. With TecEx Medical and our extensive knowledge, you can reclaim VAT upfront.
Can a CRO Act as Importer of Record?
The CRO (Clinical Research Organization), acting as the sponsor’s partner and running the trial, can serve as the IOR. However, A CRO will have limited country capabilities, thereby limiting the clinical trial reach.
An IOR role places a financial obligation on the CRO. There are certain elements of expertise the CRO needs to fulfill, so different services, such as a broker, will need to be onboarded. This adds additional complexity to project management and introduces an entirely new area of finance that must run through the CRO’s books.
In countries such as Switzerland, customs legislation changes annually, leaving CROs unable to release shipments on their own. For example, brokers previously weren’t required to hold security deposits, but now shipments can be delayed if a broker lacks sufficient cash flow.
TecEx Medical is a CRO- and vendor-neutral IOR. We work with your supply chain to expand the reach of your trials.
Can a Site or Hospital Be the Importer of Record?
A site or hospital can act as an IOR for the trial, but this can place heavy legal and financial liability on the healthcare facility. Instead, hospitals usually act only as the consignee.
Having healthcare facilities act as their own IOR has become increasingly complex due to constant customs law changes. For instance, we continually see consignees struggle with Canada CARM changes. Consignees are unaware of changes to specific licensing requirements, under which healthcare facilities are not legally permitted to release shipments in Canada.
What is the Difference Between the Consignee and the Importer of Record?
The entity serving as the IOR, who is responsible for importing clinical trial materials, brings specialized expertise in customs systems and the classification of medical materials. The consignee is the physical recipient or final destination of the clinical shipment after it clears customs. Normally, the consignee’s job is to run the trial, so they may lack the knowledgeable staff required to fulfill the job of an IOR.
Each site location acting as its own IOR constitutes multiple points of contact for the sponsor. A specialized IOR reduces the burden of several points of contact to one central point of contact.
Which Third Parties Can Specialize as the IOR for a Clinical Trial?
A specialized clinical trial IOR provider is an outsourced partner handling all medical import compliance on behalf of the sponsor. An IOR provider’s job is to stay up to date with global changes and developments, making it a master of the global trade industry.
TecEx Medical is not only a specialist IOR but also has extensive knowledge of the medical industry, particularly with global clinical trials. Drawing on our knowledge of country-specific shipping clearance timelines, from protocol idealization to submission, we can help you build more accurate clinical trial timelines and identify the best countries to ship to, based on your demographic needs and target timelines.
Can a Freight Forwarder or Courier be the Importer of Record?
A freight forwarder or courier can act as IOR if they are explicitly contracted, legally registered, and possess local licenses. However, these carriers have a different business model than that of a designated IOR provider. A freight forwarder’s job is to move a shipment, regardless of strict timelines. If a shipment is urgent, a carrier will charge more to expedite its movement.
In the USA, paper shipments for clinical trials held minimal value, and couriers could clear the shipment. After the US lowered the de minimis threshold, small shipments could no longer clear customs. Since no dedicated broker was in place to handle them, the shipments were left stranded. Currently, shipments must undergo formal clearance, which a courier can’t complete.
With TecEx Medical as your IOR provider, getting your shipments to site on time is our entire business model. For time-sensitive shipments such as radiopharmaceuticals, the active product begins to physically decay from the moment of manufacture, so prioritizing urgent shipments to meet SIV dates is in our best interest.
What if the Sponsor Has No Legal Entity in the Import Country?
When a clinical trial sponsor has no legal entity in the import country, they must appoint a representative to take the legal responsibility for the medical shipment. This entity should possess import licenses specific to IMPs (Investigational Medicinal Products), knowledge of customs documentation, and the ability to coordinate with couriers and partner with specialized logistics providers experienced in expedited medical clearance. The appointed representative acting as IOR should also hold appropriate storage and handling licenses, especially for controlled substances, biologics, or cold-chain products.
TecEx Medical Can Move Your Clinical Trials Forward
Many entities that play important roles in the supply chain can act as the IOR; however, successfully navigating the complexities of global clinical trial logistics depends on selecting the right Importer of Record. Who is responsible for importing clinical trial materials should not be treated as an afterthought or defaulted to whichever party is most convenient.
Instead, partnering with an experienced and registered IOR ensures that time-sensitive and often temperature-sensitive materials clear customs efficiently, comply fully with local regulations, and reach their destination without costly delays or compliance risks.
We work with your supply chain to expand the reach of your trials.
As clinical trials continue to expand across borders, having a knowledgeable IOR partner in place isn’t just a regulatory checkbox—it’s a critical safeguard for trial timelines, patient safety, and overall study integrity.
IOR for Clinical Trial FAQs
Can the sponsor be the Importer of Record?
Yes, the Sponsor can serve as its own Importer of Record (IOR), typically through a local entity with a physical office in the destination country. However, Sponsors often lack the specialized expertise needed to properly classify medical materials, secure the necessary licenses, and identify opportunities to reduce VAT costs.
Can a CRO act as Importer of Record?
Yes, although the CRO operating the trial can act as the IOR. However, they rarely do so due to a lack of staff with IOR-specific skills.
What is a third-party IOR provider?
The IOR provider, who is responsible for importing clinical trial materials, is a third-party, specialized, outsourced team that handles all medical import compliance on behalf of the sponsor.
Can a site or hospital be the Importer of Record?
Yes, a clinical site or hospital can technically act as IOR because it’s locally registered, but they rarely do due to high legal and financial liability.
What if the sponsor has no legal entity in the import country?
A specialist IOR provider with a legal entity should be outsourced, as without an IOR, sponsors can’t get shipments into destination countries.
Can a freight forwarder or courier be the Importer of Record?
Yes, a freight forwarder can act as IOR if they are explicitly contracted, legally registered, and possess local licenses. However, a freight forwarder operates on a different business model, so urgent trial timelines and skilled staff to clear customs are not available for shipments.
What is the difference between the consignee and the Importer of Record?
The IOR is the legal entity carrying responsibility, whereas the consignee is the physical recipient or final destination of the shipment after customs clearance.
