Strengthening Global Trade Compliance with End-to-End COO Governance

Background

A leading global MedTech company with annual revenue exceeding USD 36 billion operates across more than 150 countries, delivering a broad portfolio of medical technologies spanning Cardiovascular, Neuroscience, Medical Surgical, and Diabetes care. With a global manufacturing footprint and products distributed worldwide, the organization navigates complex trade compliance requirements across multiple markets.

To support its global trade compliance initiatives and strengthen governance across its product lifecycle, the client partnered with Tata Elxsi to establish a scalable framework for Country of Origin (COO) determination, validation, change impact management and remediation. The engagement focused on driving consistency, traceability, and compliance across thousands of products and product records distributed across multiple business units and geographies.

Challenge

The client was encountering inconsistencies in Country of Origin information across labels, Instructions for Use (IFUs), packaging artwork, regulatory submissions, and product records. As products evolved through supplier changes, manufacturing transfers, and sourcing updates, maintaining alignment across multiple records became increasingly difficult. Missing, outdated, or incorrect COO data created regulatory, customs, and trade compliance risks.

The fragmented approach to COO management resulted in data discrepancies, limited traceability, and increased compliance risks. These challenges not only impacted audit readiness but also exposed the organization to potential customs delays, shipment holds, regulatory observations, and tariff-related risks that could affect seamless global market access.

Solution

Tata Elxsi implemented a comprehensive end-to-end COO governance and remediation program to establish a standardized, accurate, and compliant Country of Origin (COO) framework across the global product portfolio. The engagement combined comprehensive reconciliation of COO information, product-level COO assessments, validation, change Impact Analysis, and remediation to identify and resolve discrepancies across systems, records, and labeling artifacts. COO data was harmonized across impacted systems, documents, and regulatory artifacts to create a single source of truth. 

Tata Elxsi developed a standardized COO determination methodology supported by governance and change-control processes to manage the impact of supplier changes, manufacturing transfers, acquisitions, and product updates. The engagement also established audit-ready documentation, traceability records, and clearly defined ownership models for sustainable COO management. To further improve efficiency and scalability, Tata Elxsi also implemented an AI-enabled automation solution for COO determination and validation.

Impact

• Standardized Country of Origin governance across multiple business units, enabling consistent and defensible COO determination across the product portfolio. 
• Comprehensive impact assessments and remediation of affected products, labels, IFUs, packaging artwork, regulatory submissions, and trade documentation to maintain compliance and business continuity 
• Reduced the risk of customs delays, shipment holds, tariff exposure, and market access disruptions arising from inaccurate COO declarations.
• Strengthened audit readiness, change-control processes, regulatory compliance, and global market access through enhanced traceability and documentation accuracy.
• Improved operational efficiency and scalability through AI-enabled automation of COO determination and validation processes.

Scope of Work

• COO Determination, Validation, Change Impact Analysis, and Remediation
• COO Process optimization
• Label Remediation
• GTO Team Support
• Implementation of an AI enabled automation tool for COO determination and validation for process optimization