21 CFR 807.40

FDA U.S. Agent for medical device establishments in South Korea

A medical device establishment in South Korea 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 1,347 import lines from South Korea, and 51 FDA import alerts list firms from South Korea.

FDA data for South Korea

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	1,347
Refusals citing registration or listing problems	NOT LISTED-118 · 507 FRNMFGREG-3280 · 439

Most refused product industries

Code		Count
79	General & Plastic Surgery	220
86	Ophthalmic	98

Most common refusal charges

Code	Count
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…	507
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…	439
UNAPPROVED-75 The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).	317
NO 510(K)-508 The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantial…	206
NO PMA-237 The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for prem…	201

Import alerts listing South Korea firms

Import alerts that list at least one firm in South Korea: 51. Recently updated:

Import Alert 16-39: Detention Without Physical Examination of Ready-to-Eat Seafood for Listeria monocytogenes
Import Alert 20-07: Detention Without Physical Examination of Juice from Foreign Processors Not in Compliance with Juice HACCP Regulation
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 South Korea firms, last 5 years

28 (Class II: 26, Class I: 2)

Recent recall reasons:

2026-09 Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in pati…
2026-05 The devices were distributed without required FDA premarket clearance or approval.
2026-03 Reports of devices sparking/popping and potentially burning patients.

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.