As global pressures—from new tariffs and trade probes to rapid technological advances—reshape the MedTech sector, Q4 finds industry leaders recalibrating strategies in the US, Asia, and the EU. This update unpacks how MedTech players are navigating trade uncertainty, driving innovation in Asia-Pacific, and preparing for change under the EU AI Act.

MedTech industry responds to Section 232 probe

The MedTech industry continues to grapple with uncertainties triggered by the Trump administration’s Section 232 national security investigation into medical equipment imports. The probe, launched in September, targets a broad spectrum of medical devices, raising the possibility of new tariffs that threaten to disrupt key manufacturing chains.

Major advocacy groups, including AdvaMed and the Medical Device Manufacturers Association (MDMA), argue that additional tariffs would “needlessly disrupt a globally integrated industry that already meets domestic demand,” risking supply disruptions and higher device costs. Trade groups are advocating for exemptions for essential medical goods and for reciprocal agreements with trusted partners to mitigate the impact. The American Hospital Association has also warned that tariffs could threaten hospital access to critical medical tools and personal protective equipment.

While the immediate financial impact is unclear, new tariffs have the potential to further squeeze margins for already burdened device manufacturers, potentially pushing companies to pass costs on to customers or consider long-term shifts in production—a process unlikely to deliver rapid relief. The public comment period closed in October, and the Department of Commerce has 270 days to report its findings and make a proposal to President Trump.

Asia’s accelerating engagement in MedTech

The MedTech industry across Asia continues to accelerate its transformation through a robust combination of government-led reforms, public-private partnerships, and regulatory modernization.

In India, new policy initiatives are establishing the country as a potential global MedTech player, with the government prioritizing reduced reliance on imported goods and services. These measures are complemented by extended support for startups and the previous establishment of Centers of Excellence, aimed at scaling exports and driving inclusive growth.

South Korea approved a $645 million R&D plan, targeting diagnostics and surgical technologies, with AI as a core focus area. The project aims to develop six flagship devices and thirteen “essential” technologies over seven years, while also advancing international cooperation in digital health and genomics research with partners like Saudi Arabia, Qatar, and India.

Malaysia’s recent reciprocal trade agreement with the US could streamline MedTech device approvals by enabling MedTech companies to submit FDA documentation for approval in Malaysia—though local registration standards are still maintained.

Singapore’s Health Sciences Authority is partnering with the Singapore Manufacture Federation Medical Technology Industry Group, to provide early regulatory support and faster market access. And finally, across Asia, MedTech startups as well as the public sector are rapidly embracing generative AI, and increasing its usage in diagnostic labs, hospital systems, and telehealth.

European Commission rolls back components of EU AI Act

The European Commission announced plans to roll back central elements of the EU AI Act and reform landmark data protection rules—including GDPR—in a bid to “simplify” digital laws and stimulate business growth.

These targeted amendments are positioned as a response to mounting industry and geopolitical pressure, including calls from the US government to loosen Europe’s digital safeguards, and warnings from senior EU economists about lagging innovation.

If enacted, the changes will make it easier for tech firms, including MedTech entities, to use personal data to train AI models without patient consent, and would reduce the burden of cookie consent banners by enabling users to manage permissions centrally. Companies developing high-risk AI systems (such as those deployed in clinical decision support, surgery, or exam scoring) could see up to 16-18 months added to compliance timelines, allowing greater flexibility and faster market access for novel products.

Industry groups have cautiously welcomed the potential multi-billion dollar savings in administrative costs, citing prospects for greater investment and new collaborations in AI-enabled diagnostics, workflow automation, and digital health delivery. However, civil society organizations are concerned with the impact a rollback of digital protections may have, including risks that sensitive health data could be used unchecked, undermining privacy and trust in AI-driven healthcare.

As the legislative process moves to the EU Parliament, MedTech leaders should monitor for further clarity on exemptions, safeguards, and harmonization with global standards.