The TecEx Medical Solution in Argentina

17 Nov 2022

The TecEx Medical Solution in Argentina

Shipping into Argentina is notorious for its complex customs requirements and lengthy lead times to import trial supplies into the country. Specific customs requirements, import licenses, and the correct valuation of commodities are essential to ensure that imports into the country are managed effectively and smoothly. Despite these restrictions and high compliance requirements, TecEx Medical is a leader in assisting with complex shipping situations for clinical trials in more than 200 territories worldwide, including Argentina.

The Medical Trial

A leading CRO contacted TecEx Medical to ship new and refurbished electronic devices as part of the eCOA (electronic clinical outcome assessment) requirement for a new study. The electronic devices (eDiaries) were shipped from the United Kingdom to multiple trial sites in Argentina for a time-bound clinical trial. Due to the nature of the goods, complex compliance requirements and product revaluations had to be reviewed for the shipments.

As an expert Importer of Record (IOR), TecEx Medical was contracted as the entity to manage all compliance requirements, including import licenses and the management of the complete shipment process from start to finish.

The Unique Challenge

The challenge for this shipment was two-fold;

The team had to collate the correct documentation required for the refurbished goods and source the National Administration of Drugs, Foods and Medical Devices (ANMAT) approval required by Argentina. Application for the ANMAT document, issued by the Argentinian Minister of Health, is a lengthy process that generally takes over 30 business days.

In addition to ANMAT approval, an import license is also required and can only be applied for after a successful application to ANMAT.

These requirements are often easily confused or neglected throughout the import process. Should the process not be managed correctly from the start of the project, it could result in significant delays at customs or ultimately in stuck shipments that will delay the study’s start date or might require a new shipment to be shipped.

The TecEx Medical Solution

TecEx Medical offers a comprehensive door-to-door solution for importing technology devices into Argentina. Our core offering as an Importer of Record (IOR) and Customs Compliance Specialist ensures that the importation is successfully completed. This solution ensures that neither the CRO, Sponsor, or site is involved as we act as the IOR and TecEx Medical take on all customs risks, which include audit, financial and legal risks. Our services are supported by freight, brokerage, clearance, and the payment of duties and taxes. Using our extensive country-specific knowledge, we were successfully listed as the IOR for the study in Argentina. TecEx Medical expertly handled all the complexities of this shipment.

A constant communication loop ensured that all parties were kept up to date at every stage of the shipment. TecEx Medical provides efficient project support at no additional cost to regularly update the study teams and assist with managing all aspects of the logistics process. Due to the complexities involved with shipping to Argentina, the team needed to work closely with our compliance and local teams to consolidate all necessary shipping documentation for the new and refurbished technology devices. The documents had to reflect the accurate pricing structure as this impacts the rates and duties incurred by the customer.

Approval was given to ship, allowing for a successful shipment of study-related material into an infamously tricky region. Overall, the entire process from creating the shipment order to completing the final delivery occurred in only 29 days, which is a heavily reduced timeline compared to average shipments. Shipping medical equipment into Argentina presents a host of complexities ranging from ensuring all paperwork is correct, pricing structures are accurate, and all the required pre-compliance documents are sourced. Our wealth of knowledge and dedicated team will ensure any shipment to any of the 200 countries we service reaches its final destination safely and in the quickest time possible.

Key Takeaways

The TecEx Medical team is accustomed to working within stringent regulations, particularly in high-compliance countries such as Argentina. Partnering with TecEx Medical, a leader in IOR, allowed for a hassle-free shipment of both new and refurbished goods into Argentina.

Reach out early – TecEx Medical has fully streamlined the process, so the earlier we can begin pre-compliance on shipments, the faster we can get approval to ship.

Due to our extensive region-specific knowledge, TecEx Medical could source a compliance document that is notorious for taking weeks for approval. This approval allowed the shipment to proceed, and the overall process was completed in less than 30 days.

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