Shifting Borders, Securing Quality: Strategic Insights for Medical Device Companies Navigating Supplier Controls Through Near-Shoring and Friend-Shoring

Recalibrating Compliance: The Legal and Regulatory Stakes

Near-shoring refers to relocating manufacturing closer to the U.S.—to places like Mexico, Costa Rica, or Puerto Rico—where physical proximity offers logistical advantages and faster responses to quality events. Friend-shoring, on the other hand, involves shifting production to politically stable allies such as Canada, India, or Poland to hedge against sanctions, tariffs, and trade wars.

From a regulatory standpoint, either path requires recalibrating your FDA compliance and QMS. ISO 13485 is not geography-dependent—your new facility must meet the same global standards for design controls, CAPA, complaint handling, and internal audits. Likewise, the FDA holds foreign contract manufacturers to the same rigorous expectations as domestic ones.

That means supplier quality agreements must be rock-solid. Technology transfer protocols must be carefully crafted to avoid quality erosion. And, perhaps most critically, your team must be ready for regulatory scrutiny—whether that’s an FDA inspection or a notified body audit under MDSAP.

Political Winds at Your Back—or in Your Face?

The current U.S. administration has made supply chain security a top priority. Recent executive orders and congressional action—including the Make PPE in America Act, the CHIPS and Science Act, and targeted tariff expansions—signal a determined push to restore domestic production, especially for critical healthcare products.

Federal agencies have been directed to prioritize domestic manufacturers in procurement and streamline regulatory pathways for U.S.-based production. The FDA has responded with efforts to expedite market access, especially for companies that realign their supply chains in accordance with national priorities.

The U.S. Department of Commerce released the attached notice regarding an investigation under Section 232 (19 USC 1862) of imports of “personal protective equipment (PPE), medical consumables, and medical equipment, including devices.”

In short, where you manufacture has become as important as how you manufacture.

Reshoring Mandates - Balancing China Market Continuity and Regulatory Complexity

In the current climate, where the U.S. is emphasizing national security in relation to domestic manufacturing, medical device companies, like multinational corporations, face a dual challenge: responding to U.S. reshoring mandates while preserving hard-won market access in critical regions such as China. The decision to move manufacturing out of China for reasons of U.S. national security can have significant regulatory consequences for commercial operations within China itself.

For example, moving production out of China would require re-registration with the National Medical Products Administration (NMPA) for the commercialization of U.S.-manufactured medical devices, if the original registration was based on local production. This could potentially jeopardize existing product registrations and market eligibility if not managed with precision. Moreover, shifting manufacturing would disrupt contract manufacturing and distribution agreements and complicate export certification. Companies also need to consider how the change in manufacturing location will affect any tax incentives it has enjoyed and the repayment of funds. Companies must prepare for restructuring their quality systems and for heightened scrutiny: China's GMP is highly aligned with ISO 13485, but the two are not equivalent.

Relocating a manufacturing facility involves more than just logistics. It requires a balance of factors such as business continuity, a stable supply of raw materials and components, cost-effectiveness, dual-market regulatory scrutiny, and geopolitical government requests.

Practical Moves: How Manufacturers Can Stay Ahead

To ensure a smooth transition that preserves speed to market and regulatory standing, medical device companies should consider the following strategic steps:

• Conduct a Regulatory Gap Analysis to assess differences in local laws, inspection readiness, labor and employment, and documentation requirements.
• Do Your Diligence During the Qualification Process through qualification audits, first article inspections, a review of regulatory and compliance history, a listing of other companies to whom the supplier services.
• Revise the QMS Documentation to reflect the new suppliers, responsibilities, and controls, including robust incoming inspection processes, associated with the updated manufacturing site.
• Build a Multidisciplinary Transition Team comprising legal counsel, quality experts, regulatory specialists, and tech ops leadership.
• Plan for Post-Market Surveillance Now—especially for high-risk devices where supplier shifts may impact field performance.
• Conduct Mock Inspections at the new site under FDA and MDSAP frameworks to ensure no surprises during audits.

How Our Experts Support a Seamless Transition

Relocation is not just operational—it’s regulatory and legal. That’s why we’ve built a team of seasoned FDA, NMPA, and EU attorneys, ISO 13485-certified auditors, and global compliance strategists to guide clients through every aspect of the journey.

Here’s what we bring to the table:

• Regulatory Expertise: From 510(k) strategies to Establishment Registrations and premarket engagements, we help clients navigate FDA territory with confidence.
• QMS Alignment: We assess, adapt, and document your QMS to ensure ISO 13485 compliance—while avoiding common pitfalls that delay approvals or trigger 483s.
• Legal Precision: Our lawyers draft and negotiate supplier quality agreements, design transfer contracts, and contingency plans tailored to meet the specific needs of international operations.
• Audit Simulation & Readiness: We conduct mock audits to prepare your new facility and staff for regulator scrutiny, ensuring inspection readiness from day one.
• Lifecycle Oversight: From validation protocols to complaint handling systems, we support ongoing compliance beyond the initial move.

Whether you're transitioning from Shenzhen to San Diego or Bratislava to Baja, we offer strategic foresight rooted in regulatory rigor—so you can scale confidently while protecting product quality and patient safety.

Final Reflections: The Time to Act Is Now

Near-shoring and friend-shoring can enhance resilience, stabilize production, and align your company with national economic and security objectives. But doing it right requires more than vision—it takes cross-functional planning, technical documentation, and unwavering compliance discipline.

For companies ready to shift borders while preserving trust, reputation, and quality, it starts with asking the right questions—and partnering with those who know how to answer them.

Let’s map your future—strategically, securely, and with regulatory precision.

Authored by Jodi Scott, Mike Heyl, and Jessie Xie.