U.S. FDA Medical Device Registration

All domestic and foreign establishments involved in the manufacture, distribution, or development of medical devices intended for sale in the United States are required to register and list their devices with the U.S. Food and Drug Administration (FDA). This includes:

Medical device manufacturers
Specification developers
Contract sterilizers
Initial exporters and importers
Repackagers and relabelers

FDA Registration Requirements

Foreign establishments must appoint a U.S. FDA Agent as a mandatory requirement. The U.S. Agent serves as the point of contact between the FDA and the overseas facility, facilitating communication and helping respond to regulatory requests, inspections, or import-related queries.

Key Compliance Elements

Establishment Registration (FURLS system)
Device Listing (for each product intended for U.S. market)
FDA U.S. Agent Designation (mandatory for non-U.S. companies)
Annual Renewal (Registration must be renewed between October 1st and December 31st of each year)
Device Classification Verification (Class I, II, or III)
510(k), De Novo, or PMA if applicable

Why Registration Matters

Failing to register or list a medical device properly may lead to:

Import holds at the U.S. border
Refusal of entry
Regulatory enforcement actions
Delays in marketing and distribution

Why Choose RAPS for US FDA Medical Device Registration

I3CGlobal is a globally recognized consultancy firm specializing in FDA regulatory compliance. As a trusted US FDA Agent, we provide end-to-end support for medical device manufacturers seeking market entry into the United States.

Our comprehensive FDA regulatory services include:

US Agent services for foreign establishments
US FDA Medical Device Registration
UDI and GUDID submission services
Electronic Medical Device Reporting (eMDR)
Medical Device Master Files (MAFs)
FDA label review and compliance
Pre- and post-inspection support, including 483 response and closure
21 CFR Part 820 implementation and EN ISO 13485 integration

With over 25 years of experience, I3CGlobal has built a strong global presence and a reputation for excellence. Our offices are strategically located in the United States, Australia, Germany, India, Malaysia, Vietnam, Thailand, South Korea, and the United Kingdom—enabling us to serve clients worldwide with local expertise and global insight.

Partner with I3CGlobal and leverage our unmatched expertise to navigate the complexities of FDA medical device regulations with confidence.

Why Do Foreign Exporters Need to Appoint an FDA Agent?

The U.S. Food and Drug Administration (FDA) requires that any foreign establishment involved in the manufacturing, preparation, or processing of medical devices intended for import into the United States must appoint a U.S. FDA Agent. This agent must be a U.S. resident and must be available to communicate with the FDA during regular business hours.

In addition to appointing a U.S. Agent, the FDA also mandates the designation of an Official Correspondent as part of the Medical Device Establishment Registration process. The Official Correspondent is responsible for maintaining the establishment's registration and device listing information.