AdvaMed CEO and President Scott Whitaker [Photo courtesy of AdvaMed]
Medical device industry group AdvaMed has weighed in on the Trump administration’s move toward new import taxes on medical products including devices.
In comments submitted to Commerce Secretary Howard Lutnick (PDF download here), AdvaMed offered an overview of the domestic medtech industry, including recent investments in the U.S., employment growth that’s outpacing the national average, and R&D spending driving medical innovation.
AdvaMed President and CEO Scott Whitaker said his group wants to work with the Trump administration “to recognize and to reward the unique strength of the U.S. medtech industry” with supportive policies.
“These policies include seeking fair and reciprocal tariff-free trade with our most important allies, aggressively addressing unfair market access barriers in specific countries, and advancing domestic regulatory reforms and procurement incentives to enhance U.S. competitiveness at home and abroad,” Whitaker said in a news release. “Appropriately tailored policies can ensure that this critical American industry continues to thrive, innovate, protect, and strengthen the economic and health care systems of our great nation.”
AdvaMed represents more than 600 medical device companies in the U.S. and said those members conduct 90% of their R&D activity in the country.
“Despite strong revenues, overall R&D spending growth has leveled off recently due to rising material costs, regulatory challenges, and economic uncertainties,” AdvaMed said in its comments. “With the tariffs imposed on medtech imports since April 2025, U.S. companies have been shifting resources to manage tariff costs, with R&D spending expected to be the most heavily impacted.”
Related: R&D spending stalls in the 2025 Medtech Big 100 ranking
AdvaMed also warned tariffs could force device manufacturers to cut jobs and pass costs along to hospitals, physicians and patients, while stifling innovative technology that is already helping reduce healthcare costs.
AdvaMed highlighted essential medtech materials and components from countries outside the U.S. including China, one of President Donald Trump’s top tariff targets. The industry group called attention to the U.S. trade surplus with China, $7.5 billion in annual medtech experts to that nation, its 2.7% share of the U.S. market and 8.5% share of U.S. medtech imports.
“Ensuring a level playing field in China is critical to U.S. export growth. China’s medtech market is the world’s second-largest on a per-country basis and will experience double-digit growth well into the 2030s,” AdvaMed said.
“China has not yet achieved a dominant position in global medical device production and value chains. At present, just one Chinese company ranks in the top 50 medtech companies by global revenue,” the group later continued, citing Medical Design & Outsourcing‘s Medtech Big 100 research project.
And when disaster strikes, it’s helpful to have a globally diverse supply chain, AdvaMed said, pointing to Baxter’s recovery from catastrophic flooding at its IV solutions plant in North Carolina as well as the diagnostic and ventilator ramp up early in the Covid-19 pandemic.
Related: There’s a shortage of life-saving devices for kids — and tariffs might make it worse
Finally, AdvaMed offered policy recommendations “to further enhance and support U.S. production,” which we’ll reproduce in full below:
AdvaMed supports the Administration’s America First trade policy with a focus on reciprocal trade and leveling the playing field and creating export opportunities for U.S. medtech manufacturers. We appreciate the opportunity to highlight how a robust U.S. manufacturing presence enables the U.S. medtech industry, across its broad range of segments and products, to both serve the varied needs of American patients and lead the world in medtech manufacturing. AdvaMed and our members stand ready to support the Administration in developing strong, common-sense policies that strengthen our allied supply chains, drive U.S. exports, and continue to provide innovative medical devices to patients in America and around the world. Through reciprocal trade arrangements with trusted countries, attention to unfair trade practices in other countries, and possible changes to the U.S. regulatory system, we can build upon the industry’s decades-long legacy as a national asset and secure its role as the engine of American medical innovation for generations to come.
America First Trade Policies to Strengthen the U.S. Medtech Industrial Base
Reciprocal Preferential Trading Relationships with Allies to Bolster U.S. Manufacturing
1. The Importance of Reciprocal Tariff-Free Trade with Europe, Japan, and the UK
Recognizing the significant growth created by 30 years of reciprocal duty-free trading relationships in the medtech industry, establishing a preferred trading bloc with NATO partners and allies will enable the continued growth of U.S. R&D and manufacturing in the medtech sector. This approach would continue to support domestic resilience and enable substantial exports.
Ensuring bilateral and reciprocal tariff-free treatment rates with the EU, UK, and Japan, and other potential reciprocal trade deal partners, will strengthen the American medical technology sector by ensuring the flow of critical products, medical parts and materials, and securing medtech manufacturing competitiveness. In addition, these trading partners maintain robust, high-standard regulatory cooperation with U.S. regulators through mutual recognition agreements and shared commitments to product safety, quality standards, and innovation. Granting tariff-free status to medical technology imports from these allies would provide the much-needed policy stability and predictability that enables companies to make rational, long-term decisions about manufacturing investments, research and development priorities, and supply chain optimization.
This treatment is consistent with the Administration’s approach in the EU, Japan, UK, and other reciprocal trade deal partners, for other critical U.S. industry sectors such as aircraft. Like these industries, the medtech industry has (1) a strong U.S. manufacturing and export base in a complex and highly-regulated technical industry, (2) a decades-long history reciprocal duty-free tariffs with these trading partners, (3) balanced trade or U.S. trade surpluses, and (4) new global challenges from unfair global competition. In addition, our sector has a humanitarian imperative to keep costs stable for the U.S. health care and hospital systems.
2. Protect North American Supply Chains and Continue USMCA Qualifying Products Rule for Mexico and Canada
AdvaMed appreciates the Trump Administration’s leadership in enacting the USMCA, setting a new benchmark for high-standard trade agreements. The USMCA has secured market and supplier access to bolster U.S. manufacturing and establish more resilient supply chains. Moreover, stronger North American supply chains have reduced dependencies on distant or adversarial suppliers, diversified sources of labor-intensive medical supplies and consumables, and lowered costs to the U.S. health care system. For example, having some operations in Mexico has enabled U.S. manufacturers to remain competitive with manufacturers much further abroad and with supply chains that are riskier and less resilient. Moreover, Canada is one of the top U.S. medtech export markets, and the United States provides over 40 percent of certain critical supplies to the Canada’s health care system. The continuation of the USMCA duty-free access for qualifying products is critical to securing resilient and affordable medical technology supply chains in North America. The Section 232 outcomes on autos and auto parts, and more recently on timber, lumber and derivative products, allowed for the USMCA qualifying rule, and this would be critical for the U.S. medtech industry as well.
3. Benefits to U.S. Manufacturing to Expanding the USMCA-type Qualifying Rule to Costa Rica and the Dominican Republic
For the medtech industry, specifically, a USMCA-type of qualifying rule for Costa Rica and the Dominican Republic would further support U.S. medtech manufacturing through additional diversification of supply chains and reduced dependencies on adversarial suppliers and would also decrease costs to the U.S. health care system. This approach would be in line with the Administration’s position that certain Western Hemisphere partners provide important alternatives for products and inputs that cannot be realistically made in America. Specifically, this model would further bolster our industry’s ability to diversify sources of labor-intensive medical supplies and consumables.
4. Continuation of Duty Drawback
Since many U.S. medtech producers use the United States as an export base from which to serve global customers, it is critical that duty drawback continue to be made available for medtech imports, as it is for reciprocal tariffs and for the recently announced Section 232 tariffs on timber, lumber, and derivative products. U.S. jobs rely on a strong export base, which is supported by the duty drawback program. Otherwise, U.S. exports could be jeopardized or made less competitive in international markets.
5. Phased-in Implementation of Any Tariffs, Given the Highly Regulated Nature of Medtech If any additional tariffs are considered, then a three-year tariff deferral reported in the recent deals in other sectors would be a useful reference for the medtech industry. A phased approach would allow manufacturers time to create new supply sources, secure the necessary regulatory approvals and certifications to shift their manufacturing, and continue to ensure the availability of safe, reliable, and effective devices for American patients and the U.S. health care system.
6. Bilateral Medtech Commitments to Secure Greater Access from Key Global Markets
AdvaMed members urge the Administration to support U.S. medtech manufacturing by pursuing commitments from trading partners to treat American products fairly in the regulatory and government procurement processes.
China: We urge the Administration to support U.S. medtech manufacturing by pursuing purchase commitments by China (as well as by any other trading partners negotiating purchase commitments as part of a bilateral trade deal) to continue to level the playing field for U.S. companies. China’s medtech market has registered double-digit growth in recent years, due to a rapidly aging population and a growing middle class. As the Trump Administration seeks to boost U.S. exports, we believe the U.S. medtech industry is uniquely positioned to meet pent-up demand in the world’s second largest economy. U.S. exports of medtech to China are stagnating due, in part, to policy challenges restricting market access. The Administration might refer to China’s previous purchase commitments of U.S. medtech — commitments that were not met —to bolster its case.
China’s market for medtech, in which government-funded hospitals are the primary purchasers, has become increasingly difficult for U.S. companies to access in recent years. We would welcome the opportunity to continue working with U.S. government agencies to secure commitments from China to mitigate these procurement and localization barriers and related discriminatory policies for government procurement including: (1) no further expansion of scope of Volume-Based Procurement (VBP); (2) ensuring sustainable prices by incorporating value-metrics into VBP and limiting cuts to 10 percent; and (3) exemption of medtech from the domestic content requirements under development for government procurement. In addition, China should eliminate country-of-origin requirements in its regulatory approval process.
India: The United States maintains a robust trade surplus with India in the medical devices sector in large part due to the country’s high dependence on imports and its nascent domestic industry. Specifically, we would welcome the opportunity to continue working with U.S. government agencies to secure commitments from India to resolve the following medtech challenges in the Indian market during bilateral trade negotiations with the United States: (1) price controls and an opaque pricing policy, which have exacerbated uncertainty in the market; (2) a public procurement order which continues to restrict some U.S. medical device manufacturers’ access to India’s government procurement market; (3) standards that include provisions for preferences for products meeting Indian standards over global consensus standards; and (4) to date, a ban on the import of refurbished medical equipment.
Pathways for U.S. Regulatory Framework to Bolster U.S. Competitiveness
7. Establish a “MAHA” Pathway to Fast-track Innovation
The establishment of a new “MAHA” (Make America Healthy Again) pathway would allow the FDA to provide priority treatment and expedited review (through the 510(k), PMA, or de novo processes) for medtech products substantially developed and manufactured in the United States. The objectives would be to reduce submission review times related to manufacturing and supplier changes and then appropriately be afforded accelerated coverage and payment (for new technologies without a Medicare benefit category). By significantly reducing regulatory timelines and providing accelerated coverage and payment, this policy would directly reward firms for their U.S. investments in R&D, manufacturing, and new products. It would also ensure that American patients receive first access to the safest and most advanced medical solutions in the world and maintain and grow U.S. leadership in the global medtech industry.
8. Increased Global FDA Inspections to a Level Commensurate with Inspections in the United States
We support the FDA’s increased oversight of foreign medtech manufacturers to a level commensurate with the inspection of U.S. facilities. Domestic manufacturers traditionally undergo far greater inspection oversight, creating an uneven playing field. Building on the FDA’s risk-based inspection model, the agency should conduct more surveillance inspections of foreign manufacturers to ensure they face the same level of regulatory scrutiny as their U.S. counterparts. This increased oversight is particularly critical for facilities in jurisdictions where on-site investigations have been difficult or where local manufacturers have anomalously low rates of post-market event reporting. Congress should appropriate funds specifically directed to funding foreign facility investigators to increase medtech inspections specifically to reduce the gap between foreign and domestic establishments.
9. Increased Surveillance of Testing Laboratories Outside the United States Producing Fraudulent Data
FDA has identified an increase in submissions with data integrity issues, often associated with certain third-party testing laboratories. FDA highlighted “testing data that are fabricated, duplicated from other device submissions, or otherwise unreliable.” FDA also “identified an increase in submissions containing unreliable data generated by third-party test labs.” Device applications with data integrity issues are clogging up the review process and potentially could slow down reviews for legitimate device applications. Other regulatory regimes have a concept of “immediate jeopardy,” in which, if there are credible indications of fraud or a pattern of unacceptable performance, FDA should be given authority to suspend a lab immediately, with website publication so that companies know right away not to work with that lab, as well as automatic termination from the Accreditation Scheme for Conformity Assessment (ASCA) program.
10. Prioritize “America First” Regulatory Approvals: Reliance on U.S. FDA Approvals and Clearances in Key Markets
We would welcome the opportunity to continue to work with the Administration to secure the acceptance of U.S. FDA approvals and clearances in key foreign markets. This “America First” approach would create a powerful incentive for manufacturers to bring their most innovative products to the U.S. market first, ensuring American patients receive access to cutting-edge, life-saving technologies before any other country. By allowing companies that secure U.S. approval to bypass duplicative regulatory reviews abroad, this policy would result in a significant competitive advantage for American innovators, streamline global market access, and reduce costs for manufacturers and patients alike.
The foundation for this policy is already in place. The FDA is the global leader in medtech regulation, known for its scientific rigor and expertise. Regulatory authorities from our key global trading partners, such as the UK and Switzerland, The foundation for this policy is already in place. The FDA is the global leader in medtech regulation, known for its scientific rigor and expertise. Key global trading partners, such as the United Kingdom and Switzerland, have recognized FDA as a trusted regulatory partner and taken steps within their own domestic regulatory schemes to rely on FDA approvals for market entry. We urge the Administration to build on this momentum. A specific focus should be placed on securing a reliance agreement with Mexico, given its critical role in the North American supply chain and its status as an affiliate member of the International Medical Device Regulators Forum (IMDRF). Efforts should also expand to emerging markets in Latin America and Southeast Asia to cement the FDA’s global leadership and further boost the competitiveness of U.S. medtech exports.
11. Further Workforce Investments to Support Expanded and New U.S. Investments
We also recommend significantly increasing investments in workforce training to support the medical technology sector’s innovation and manufacturing capabilities. Building a skilled workforce is essential to sustain the investments in domestic production that have been made during the Trump Administration’s first and second terms, secure medical device supply chains, and accelerate the development and delivery of breakthrough health care technologies. By fostering partnerships among government, industry, and educational institutions, the government can ensure a pipeline of talent equipped with the advanced technical and regulatory knowledge critical for medtech innovation. Support from programs like BARDA (the Biomedical Advanced Research and Development Authority), which provide funding, mentorship, and technical guidance for health security innovations, can amplify these efforts.
Investments in workforce training are especially critical for small- and medium-sized medical device enterprises (SMEs), which face unique resource constraints but drive much of the industry’s disruptive innovation and job creation. Tailored training for SMEs enables rapid upskilling, enhances regulatory compliance, and boosts their ability to compete and collaborate within the broader ecosystem. These efforts will maintain America’s leadership in medical technology, improve patient outcomes, and enhance health care system resilience against future challenges. We would appreciate consideration of the Administration’s use of the revenue collected from reciprocal tariffs on medtech since April 2025 to provide zero- or low-interest loans to small and medium-sized medtech companies. These loans would be used for U.S. manufacturing facilities and/or equipment, the training of local employees, and covering the costs related to regulatory approvals.
