Is the IoR the same as a U.S. Agent?

No. The U.S. Agent is required for facility registration and FDA communications. The IoR is responsible for the import transaction and customs declaration. We offer both services if needed.

Do foreign manufacturers need a U.S. Agent?

Yes. Foreign medical device manufacturers must appoint a U.S. Agent for: • FDA communications and submissions • Emergency contact during compliance reviews

What is the difference between device registration and listing?

• Registration: Identifies the facility (manufacturer, importer, etc.) with the FDA. • Listing: Identifies the specific devices being marketed by the registered facility. Both are required annually.

How often must FDA registrations be renewed?

• Annually between October 1 and December 31. • Failure to renew on time may result in registration invalidation and import refusals.

What is an Importer of Record (IoR) for a medical device?

An IoR is a U.S.-based entity that legally imports and declares a medical device, assuming responsibility for customs, FDA compliance, and post-market accountability.

What documents are required for medical device import?

Typical documents include: • Commercial invoice • FDA product code and device listing • 510(k) clearance or exemption notice • Label with U.S. contact information • Customs entry forms (CBP)

US Agent & Importer Support for Medical Devices

Overview

Service overview

We act as your US Agent for FDA communications, support establishment registration and device listing, and can act as your US Importer of Record.

Product documentation being reviewed for compliance

Why this service matters

FSVP is an FDA food rule (21 CFR Part 1, Subpart L) and does not apply to medical devices.
Foreign device establishments must appoint a US Agent to handle FDA communications and emergency enquiries.
Without a valid importer, shipments can be delayed, detained or refused entry by CBP or the FDA.

Registration, Listing & US Agent

For device importers, the requirements that matter are establishment registration and device listing, a US Agent for foreign establishments, and a clearly defined importer.

Establishment registration under 21 CFR Part 807, renewed each year between 1 October and 31 December
Device listing for the specific devices your registered facility markets
Official US Agent designation for FDA registration purposes
Support for regulatory enquiries, compliance notifications and post-market surveillance requirements

Cargo containers moving through an international port — Medical Devices & Cosmetics
US Agent & Importer Support for Medical Device Importers

US Agent vs Importer of Record

The US Agent handles facility registration and FDA communications, while the Importer of Record is responsible for the import transaction and customs declaration.

Declaring the device to US Customs and the FDA
Ensuring all regulatory requirements are fulfilled
Maintaining documentation for audits or inspections
Providing a point of contact for the FDA

How We Support Device Imports

We can act as your US Importer of Record for Class I and Class II devices and, as your US initial importer, handle FDA registration, recordkeeping and post-market duties.

Entry declarations to CBP and the FDA
Labelling and packaging review, including placement of the US importer's name and address
Coordination with your US Agent or regulatory consultant for devices that need 510(k) clearance
Initial importer registration with the FDA, renewed each year between 1 October and 31 December

Typical Import Documents

These are the documents a medical device import typically needs.

Commercial invoice
FDA product code and device listing
510(k) clearance or exemption notice
Label with US contact information
Customs entry forms (CBP)

Ongoing compliance support

US Agent
A US-based point of contact for FDA communications and emergency enquiries.
Registration & listing
Establishment registration renewed each year between 1 October and 31 December, with device listings kept up to date.
Importer support
Entry declarations to CBP and the FDA, with records maintained for audits or inspections.

What you'll need

Device imports move smoothly when these documents are in order.

Commercial invoiceFor the customs entry.
Product code and listingFDA product code and device listing.
510(k) clearance or exemptionEvidence of your device's premarket status.
Label with US contactIncluding the US importer's details.
Customs entry formsThe CBP forms for the shipment.

US Agent & Importer Support for Medical Device Importers