Tariffs add to regulatory burdens for medical device makers
May 08, 2025
by Gus Iversen, Editor in Chief
Medical device manufacturers are facing mounting regulatory challenges as shifting tariffs continue to reshape global trade dynamics, according to a new report from GlobalData.
While tariffs are intended to shield domestic industries, they are complicating compliance processes for multinational companies. When key materials or components are hit with tariffs, many manufacturers are forced to adjust their supply chains — whether by changing suppliers, redesigning products, or relocating production. These operational shifts can inadvertently trigger additional regulatory requirements.
In the U.S., even minor modifications to device components may necessitate new 510(k) submissions or amendments to existing approvals through the Food and Drug Administration, adding to compliance costs and potentially delaying product availability.
Elia Garcia, medical analyst at GlobalData, noted, “For multinational manufacturers, managing compliance across several jurisdictions becomes increasingly burdensome under these conditions. Regulatory timelines are stretched, innovation cycles are disrupted, and internal resources are redirected toward navigating evolving trade and compliance dynamics.”
Some companies have reported increased costs tied to tariffs on overseas components and are exploring moving portions of their manufacturing to domestic sites to reduce exposure. However, such transitions come with their own regulatory hurdles, often requiring updates to documentation and revalidation of production processes. These steps can trigger further approval requirements in regions including the European Union and Canada, adding layers of complexity.
Garcia added, “As the medical device industry continues to adapt to global economic shifts, manufacturers are calling for greater alignment between trade policy and regulatory frameworks to support patient access, innovation, and operational resilience.”
GlobalData’s analysis underscores how international trade policies are increasingly intertwined with regulatory compliance, creating new operational pressures for medical device companies worldwide.
While tariffs are intended to shield domestic industries, they are complicating compliance processes for multinational companies. When key materials or components are hit with tariffs, many manufacturers are forced to adjust their supply chains — whether by changing suppliers, redesigning products, or relocating production. These operational shifts can inadvertently trigger additional regulatory requirements.
In the U.S., even minor modifications to device components may necessitate new 510(k) submissions or amendments to existing approvals through the Food and Drug Administration, adding to compliance costs and potentially delaying product availability.
Elia Garcia, medical analyst at GlobalData, noted, “For multinational manufacturers, managing compliance across several jurisdictions becomes increasingly burdensome under these conditions. Regulatory timelines are stretched, innovation cycles are disrupted, and internal resources are redirected toward navigating evolving trade and compliance dynamics.”
Some companies have reported increased costs tied to tariffs on overseas components and are exploring moving portions of their manufacturing to domestic sites to reduce exposure. However, such transitions come with their own regulatory hurdles, often requiring updates to documentation and revalidation of production processes. These steps can trigger further approval requirements in regions including the European Union and Canada, adding layers of complexity.
Garcia added, “As the medical device industry continues to adapt to global economic shifts, manufacturers are calling for greater alignment between trade policy and regulatory frameworks to support patient access, innovation, and operational resilience.”
GlobalData’s analysis underscores how international trade policies are increasingly intertwined with regulatory compliance, creating new operational pressures for medical device companies worldwide.