Helping Non-U.S. Manufacturers Navigate FDA Requirements
Entering the United States medical device market requires far more than completing registration. The U.S. regulatory environment, governed by the U.S. Food and Drug Administration (FDA), is highly structured and demands careful coordination across multiple regulatory domains.
Non-U.S. manufacturers must address establishment registration and device listing requirements, determine the appropriate regulatory pathway, 510(k), De Novo, or PMA, align with Quality Management System Regulation (QMSR) expectations, and maintain effective ongoing communication with the FDA. Without a clear strategy, missteps in any of these areas can lead to delays, costly rework, or barriers to market access.
Medical Devices and Pharma (MDP) provides integrated support designed specifically for international manufacturers navigating these requirements. Our approach combines formal U.S. Agent representation with practical, experience-based regulatory guidance. We work closely with your organization to clarify FDA expectations, identify and avoid common pitfalls, and move efficiently toward compliance and successful market entry.
Through our services, clients receive comprehensive support tailored to their stage of development and regulatory needs. This includes U.S. Agent representation to fulfill FDA requirements and facilitate communication, guidance on establishment registration and device listing, advisory support in selecting and executing the appropriate regulatory pathway, and alignment of quality systems with QMSR and ISO 13485 expectations. Our objective is not only to ensure compliance, but to position your organization for efficient and sustainable participation in the U.S. market.
We offer flexible service options to match the needs of different organizations. For companies requiring only regulatory representation, our U.S. Agent service provides the essential FDA-designated contact and communication support, typically ranging from $1,500 to $3,000 annually.
For organizations seeking broader support, our Agent and Advisory package combines U.S. Agent services with regulatory guidance and market entry strategy, generally ranging from $3,000 to $10,000 or more depending on scope.
For companies requiring continued engagement, we provide ongoing support through a retainer model, offering strategic guidance, issue resolution, and monthly regulatory support, typically ranging from $1,000 to $3,000 per month.
The importance of a structured approach to U.S. market entry cannot be overstated. Without proper guidance, regulatory expectations are often misunderstood, submissions may be delayed, and market access can be slowed or even blocked. By contrast, a well-defined strategy reduces risk, improves efficiency, and accelerates progress toward commercialization.
These services are designed for non-U.S. medical device manufacturers entering the U.S. market, companies expanding their regulatory operations, and international regulatory teams seeking reliable U.S.-based support. If you are preparing to enter the U.S. market, we invite you to begin with a structured discussion. We will review your product, your objectives, and your potential regulatory pathways, and help you define a clear and effective strategy for moving forward.