21 CFR 807.40

FDA U.S. Agent for medical device establishments in China

A medical device establishment in China that exports to the United States must register with FDA and name a U.S. Agent located in the U.S. (21 CFR 807.40). In the 12 months from 2025-10 to 2026-09, FDA refused 2,749 import lines from China, and 85 FDA import alerts list firms from China.

FDA data for China

Figures from FDA public data, retrieved 2026-10-21. Recall counts are by the recalling firm's country.

Import refusals, 2025-10 to 2026-09

Refused import lines	2,749
Refusals citing registration or listing problems	NOT LISTED-118 · 388 FRNMFGREG-3280 · 279

Most refused product industries

Code		Count
80	General Hospital/Personal Use	133

Most common refusal charges

Code	Count
TP NO PMTA-3842 This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it is a tobacco product that FDA has found to be adulterated under section 902(6)(A) of the FD&C …	415
MELAMINE-3421 The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to bear or contain a food additive, namely melamine and/or a melamine analog, that is unsafe within the…	401
TP NO SE-3843 This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it is a tobacco product that FDA has found to be misbranded under section 903(a)(6) of the FD&C A…	396
NOT LISTED-118 The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. Based on the information…	388
FRNMFGREG-3280 The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. Based on information available to FDA, i…	279

Import alerts listing China firms

Import alerts that list at least one firm in China: 85. Recently updated:

Import Alert 16-129: Detention Without Physical Examination of Seafood Products Due to Nitrofurans
Import Alert 16-39: Detention Without Physical Examination of Ready-to-Eat Seafood for Listeria monocytogenes
Import Alert 45-02: Detention Without Physical Examination and Guidance of Foods Containing Illegal and/or Undeclared Colors.
Import Alert 45-06: Detention without Physical Examination of Stevia Leaves, Crude Extracts of Stevia Leaves and foods Containing Stevia Leaves and/or Stevia Extracts
Import Alert 99-05: Detention Without Physical Examination Of Raw Agricultural Products for Pesticides
Import Alert 99-08: Detention without Physical Examination of Processed Human and Animal Foods for Pesticides

Recalls by China firms, last 5 years

208 (Class II: 175, Class I: 31, Class III: 1, Not Yet Classified: 1)

Recent recall reasons:

2026-10 Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter
2026-10 Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are …
2026-09 The 6Fr suction catheter could not pass through the samples smoothly.

What the rule requires

Every foreign establishment that manufactures, prepares, propagates, compounds or processes a medical device imported into the United States must register with FDA, list its devices, and designate a single U.S. Agent. Registration is renewed every year between October 1 and December 31, and FDA's annual establishment fee must be paid first.

Foreign manufacturers, contract manufacturers, contract sterilizers, specification developers, repackagers, relabelers and some kit assemblers of devices exported to the U.S.
Initial importers in the U.S. register separately; they do not need a U.S. Agent

Deadlines

Register within 30 days of beginning an operation that requires registration
Renew annually between October 1 and December 31 (21 CFR 807.22)
Pay the annual establishment registration user fee before submitting

Steps

Pay FDA's annual establishment registration fee through the Device Facility User Fee website and get a Payment Identification Number
Create an account in FDA's FURLS Device Registration and Listing Module (DRLM)
Your official correspondent enters the establishment, owner/operator, U.S. Agent and device listings
FDA emails the U.S. Agent to confirm the designation
Keep your FEI and owner/operator number on file

Common mistakes

Paying the user fee but never completing the registration in DRLM
Naming a U.S. Agent who has not agreed. The agent must confirm in FDA's system
Forgetting to list each device under the correct product code
Believing that registration means FDA has cleared or approved the device. It does not

How US Agent Desk helps

We serve as your U.S. Agent, prepare the registration data in your language for your company's officer to submit, confirm the designation when FDA asks, and check FDA's public records for your company every morning. Prices start at $990 per year.

Check if you need a U.S. Agent See prices

Sources

Independent private service. Not affiliated with the U.S. FDA. Not legal advice.