US Agent for Medical Devices
Under 21 CFR 807.40, every foreign establishment must designate a US Agent. We provide compliant US Agent services — your legal point of contact with the FDA, from registration and listing to inspection support, with bilingual coordination throughout.
Why Do You Need a US Agent?
Under 21 CFR 807.40, any establishment outside the United States that manufactures medical devices for sale in the US must designate a US Agent and complete establishment registration and device listing.
The US Agent is the legal liaison between the FDA and the foreign establishment: FDA correspondence, inspection notices and product enquiries all flow through the agent. The agent must reside or maintain a place of business in the US — a PO box or answering service alone does not qualify. Products without a designated agent may be refused entry at the border.
- Applies to all foreign establishments (manufacturers, contract manufacturers, repackagers and more)
- Establishment registration must be renewed each year between October 1 and December 31
- Medical device reports (MDR) and FDA inspections require agent coordination
Regulatory Basis
Our US Agent services follow the current FDA regulatory framework.
US Agent Provision
Designation obligations for foreign establishments and agent qualifications: a real US place of business, liaison duties and correspondence relay.
Registration & Device Listing
Assist with Establishment Registration and Device Listing, including the annual renewal window (Oct 1 – Dec 31) and listing changes.
Medical Device Reporting (MDR)
Adverse events must be reported to the FDA within statutory timeframes; the agent helps receive requests, coordinate reports and follow-up communication.
Quality System & Inspections
The FDA Quality System Regulation (QSR) and inspections: the agent receives inspection notices and supports scheduling and communication.
Our Services
Full-lifecycle US Agent coverage, from the agreement to annual renewal and inspection support.
US Agent Agreement
Signed agent agreement defining liaison duties, correspondence relay and scope of mandate, compliant with 21 CFR 807.40.
Registration & Listing Assistance
Assist with FURLS establishment registration and device listing, annual renewal (Oct 1 – Dec 31) and listing changes.
FDA Correspondence Relay
Receive FDA letters, enquiries and notices; relay them promptly and help draft replies — with bilingual support throughout.
Incident Report Coordination
Help determine reportable events, coordinate MDR submissions (21 CFR 803) against statutory deadlines and manage FDA follow-up.
FDA Inspection Support
Receive inspection notices, assist with scheduling and support communication during inspections under the Quality System Regulation (QSR).
Label & Registration Consistency
Label requirement advice and cross-checking of FDA UDI and registration/listing data — avoiding label-to-registration mismatches.
Change & Renewal Management
Registration changes, annual renewal and FDA fee reminders — keeping your registration from lapsing.
Ongoing Compliance Maintenance
FDA regulatory tracking, annual compliance review and support for new products and establishments.
Our Process
A clear, predictable process — registration starts right after signing.
Needs Assessment
Confirm establishment type, products and registration status; receive a proposal and quote.
Agreement
Sign the US Agent agreement defining the mandate and communication protocol.
Registration & Listing
Complete establishment registration and device listing (or the annual renewal) with FDA confirmation.
Liaison & Inspection Support
Correspondence relay, incident coordination and inspection support as needed.
Annual Maintenance
Complete the Oct–Dec annual renewal and manage changes in real time.
Our Advantages
Compliant US Liaison Entity
A representative entity with a real US place of business — meeting the 21 CFR 807.40 qualification requirements.
Bilingual, Zero Time-Zone Friction
Direct communication with our Shenzhen-based team; FDA letters, reports and replies handled in both languages — important notices relayed immediately.
Multi-Market Bundling
EC-REP, US Agent and BRH under one roof — registration data and labelling requirements managed consistently, no duplicated onboarding.
Frequently Asked Questions
Who must designate a US Agent?
All establishments outside the US that manufacture medical devices for sale in the US — manufacturers, contract manufacturers, repackagers, specification developers and more — must designate a US Agent under 21 CFR 807.40.
How is a US Agent different from an importer or distributor?
The US Agent is the statutory liaison between the FDA and the foreign establishment — handling correspondence and inspection assistance. It takes no part in commercial distribution and bears no product liability. Importers and distributors are commercial roles with their own obligations; the three cannot substitute for one another.
Does the US Agent need a US place of business?
Yes. The agent must reside or maintain an actual place of business in the United States. A post-office box or answering service alone does not satisfy the FDA's requirements.
When must establishment registration be renewed?
Foreign establishments must renew their registration every year between October 1 and December 31. A lapsed registration means products cannot legally enter the US market — we remind and assist before every window.
What should I watch out for when changing agents?
A change involves FDA registration updates, correspondence handover between old and new agents, and a transition plan for responsibilities. We recommend defining the handover in the agreement — and we can manage the full switch.
How does the 510(k) relate to the US Agent?
They are independent: the 510(k) is a premarket submission, while the US Agent covers the establishment-registration and listing liaison obligations. Even before your 510(k) is cleared, you should designate an agent and register if you plan to enter the US market.
How are the fees calculated?
Fees typically comprise a contracting fee and an annual maintenance fee, determined by the number of establishments and device listings (FDA registration fees are charged separately per the FDA's current fee schedule). Submit your information via the contact page and we will quote within 24 hours.
Ready for the US market?
Submit your establishment and product information — receive a proposal and quote within 24 hours.