The healthcare supply chain is truly global. Many of the components used in medical products and diagnostic tests are sourced, manufactured, or assembled across multiple countries. While this global scale enables innovation and efficiency, it also makes transparency and regulatory compliance more complex. As a result, accurately determining a product’s country of origin has become more important than ever—particularly for diagnostic products used in patient care.
Understanding country of origin requirements helps manufacturers, distributors, and providers ensure compliance, build supply chain visibility, and maintain trust. Below, we explore what country of origin means, why it matters in diagnostic testing, and how domestic sourcing is shaping the future of healthcare manufacturing.
What Does Country of Origin Mean?
Country of origin refers to the country where a product is produced, manufactured, or assembled. This designation plays a critical role in trade regulations, consumer decision‑making, and global market dynamics. 1
All goods entering the United States must be clearly and legibly marked in English with their country of origin, a requirement enforced by U.S. Customs and Border Protection.
A free trade agreement (FTA) determines the country of origin based on criteria set by the text of the agreement. If there is no FTA or unilateral preference program, several factors determine the rule of origin. To change a product’s country of origin, the government must determine that it underwent a substantial transformation based on:2
- Country of origin of any components
- Extent of processing within a country
- Whether processing gives it a new name, use, and character
- Resources expended on product design & development
- Extent of post-assembly inspection and testing procedures
- Skills required during the manufacturing process
Why Does Country of Origin Matter?
For diagnostic products, country of origin labeling is not just a regulatory requirement—it is a matter of transparency, safety, and trust.
Country of origin designations play a critical role in healthcare supply chain visibility. The COVID‑19 pandemic highlighted how vulnerable global supply chains can be, underscoring the need for greater transparency from raw materials through final product delivery. By clearly identifying a product’s country of origin, manufacturers and distributors can better manage risk, respond to regulatory changes, and support better patient outcomes. 5
Also, organizations can better anticipate disruptions, reduce waste, and strengthen supply chain resilience because in today’s supply chain, visibility has evolved from an operational necessity into a strategic advantage6
Domestic Sourcing as a Strategic Solution
A 2025 industry survey by the Health Industry Distributors Association (HIDA) found that 52% of medical product manufacturers planned to expand their U.S. production footprint within two years, and 67% expected domestic manufacturing to increase over five years.7
Regulatory attention is also intensifying. In March 2026, President Donald J. Trump signed an executive order aimed at combating fraudulent “Made in America” claims by foreign manufacturers and sellers. The order is designed to ensure that products marketed as American‑made meet established standards, reinforcing the importance of accurate country of origin designations and truthful labeling. 8
Overall, the U.S. medical supply chain is becoming a hybrid of domestic, nearshore, and global sources – with a deliberate tilt toward more local capacity for anything mission-critical 9. This doesn’t mean isolating from global trade entirely (most manufacturers still rely on some imported inputs), but it means creating a robust domestic backbone for health supplies.
Notably, a HIDA survey found 98% of medical manufacturers anticipate a broad industry exit from reliance on China in the coming years. Companies plan to expand existing U.S. plants, build new ones, reshore previously offshored lines, and develop new “Made in USA” products to fill gaps7.
The end game is a supply chain that can withstand global shocks and ensure that American hospitals, labs, and consumers aren’t left unprotected when the next crisis strikes.
Why Made in the USA?
The push for U.S.-made medical products is about more than just economics or patriotism – it’s rooted in fundamental concerns about safety, stability, and self-reliance.
- National Security & Public Health Preparedness:
- Medical supplies are as strategic to national security as energy or defense hardware. U.S. leaders view a robust domestic manufacturing base for medical goods as essential to national defense. By producing items like PPE, diagnostics, and vaccines on U.S. soil, the nation can respond faster to pandemics, bioterrorism, or war-time supply disruptions. Bolstering domestic supply is thus a form of insurance policy for public health emergencies.
- Economic Impact and Innovation Ecosystem:
- Revitalizing medical manufacturing at home also yields significant economic and strategic benefits.
- New factories and production lines mean new jobs – often in advanced manufacturing, engineering, and biotech – which strengthen local economies. Recent investments by just a handful of healthcare companies are bringing well over 3,000 high-skilled jobs to U.S. communities9,10.
- The domestic focus is also sparking new startups and partnerships. For example, multiple U.S. states are establishing Innovation Hubs and advanced manufacturing centers for pharmaceuticals and biotech. In the long run, these hubs can become self-sustaining ecosystems, where universities, startups, and manufacturers collaborate – reinforcing America’s leadership in medical technology.
- Lastly, by reducing import reliance (and the associated shipping emissions), local manufacturing even offers environmental and sustainability advantages, aligning with the healthcare industry’s growing focus on reducing its carbon footprint9.
- Revitalizing medical manufacturing at home also yields significant economic and strategic benefits.
For medical devices—including diagnostic products—the U.S. Food and Drug Administration (FDA) is responsible for ensuring compliance with U.S. regulations before, during, and after importation. Foreign manufacturers are required to meet the same regulatory standards as domestic manufacturers before their products can enter the U.S. market. Once imported, the FDA verifies and enforces applicable medical device requirements. 3
References
- Country of Origin Determination, Star USA
- Rules of Origin at a Glance, HIDA
- Importing Medical Devices and Radiation-Emitting Electronic Products into the U.S., FDA
- Marking of Prescription Medication for Retail Sale, U.S. Customs Border and Protection
- Making Strides Towards Visibility, HIDA
- How Supply Chain Visibility Improves Modern Healthcare Management, SupplyChain247
- Top 3 Ways The United States Is Securing The Future Of Healthcare, HIDA
- Fact Sheet: President Donald J. Trump Ensures Truthful Advertising of Products Claiming to be Made in America, The White House
- Reshoring Trends in the Medical Industry
- Eli Lilly doubles down on US drug manufacturing
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