Medical device companies operating across U.S. and Chinese markets are facing a rapidly shifting regulatory environment. As geopolitical tensions between the two nations intensify, firms must reevaluate their global strategies—particularly when it comes to supply chains, partnerships, and compliance efforts.
Legislative Spotlight: The BIOSECURE Act
At the center of this shift is the proposed BIOSECURE Act, a bipartisan measure in the U.S. Congress. If enacted, it would prohibit federal contracts and funding for organizations that engage with specific Chinese firms—especially those in the biotech and genomics sectors that raise national security concerns. Though still under legislative review, the bill is already influencing corporate behavior, pushing medtech companies to scrutinize their operations for potential exposure to restricted entities.
Currently, five Chinese firms are named under the legislation. Companies would have until 2032 to cut ties with these “entities of concern,” though there’s speculation that the timeline could be shortened depending on how geopolitical conditions evolve. The FDA and FCC specifically are not accepting test results from these Chinese firms and others.
Declining Confidence in Cross-Border Collaboration
Surveys within the life sciences industry reveal a sharp decline in executive confidence when it comes to partnering with Chinese companies. This drop reflects not only regulatory apprehensions but also fears around supply chain vulnerabilities and reputational risks. As scrutiny increases, firms are reconsidering their dependencies on Chinese manufacturing and research entities.
Strategic Recommendations for Medical Device Manufacturers
To prepare for and respond to this changing landscape, medtech companies should take the following steps:
- Gain a Clear Understanding of Emerging Policies
Familiarize leadership and compliance teams with the BIOSECURE Act and related legislative proposals. Assess current relationships with Chinese suppliers and determine any potential risks to U.S. federal funding eligibility. - Review and Map Supply Chains
Conduct a detailed audit of suppliers and subcontractors, paying close attention to ownership structures and geographical affiliations. Transparency across the supply chain will be crucial for future regulatory compliance. - Establish Backup Plans for Operations
Diversify sourcing and manufacturing options to reduce overreliance on any single country or region. Building flexibility into logistics and inventory management can help companies adapt quickly to regulatory or trade disruptions. - Strengthen Cybersecurity Infrastructure
With increasing concerns around data privacy and security, medical device firms must prioritize the protection of proprietary data and digital systems. A proactive cybersecurity strategy is now a core component of risk management. - Foster Organizational Resilience
Companies that invest in agility—whether through internal policy adjustments, workforce training, or operational decentralization—will be better equipped to handle uncertainty and change.
Turning Compliance into Competitive Advantage
Although the current climate introduces new challenges, it also creates an opportunity for medical device companies to lead with transparency, accountability, and strategic foresight. By aligning early with expected regulations and adopting resilient practices, organizations can position themselves as trusted partners in a more complex global marketplace.
As an ASCA certified FDA lab, F2 Labs is expertly positioned to assist medical device manufacturers in their regulatory needs to get their devices to market. Reach out to us today to help craft a regulatory pathway for your particular device.
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