21 CFR 807.40

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

A medical device establishment in Taiwan 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 266 import lines from Taiwan, and 46 FDA import alerts list firms from Taiwan.

FDA data for Taiwan

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	266
Refusals citing registration or listing problems	NOT LISTED-118 · 42 FRNMFGREG-3280 · 27 REGISTERED-341 · 22

Most refused product industries

Code		Count
86	Ophthalmic	38
75	Chemistry	17

Most common refusal charges

Code	Count
UNFIT4FOOD-3422 The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be unfit for food.	110
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…	42
NO PROCESS-83 The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured und…	30
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…	27
REGISTERED-341 The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that it appears the device is subject to listing under 510(j) and the initial distributor has not regis…	22

Import alerts listing Taiwan firms

Import alerts that list at least one firm in Taiwan: 46. 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 99-08: Detention without Physical Examination of Processed Human and Animal Foods for Pesticides
Import Alert 99-19: Detention Without Physical Examination of Food Products Due to the Presence of Salmonella
Import Alert 99-35: DETENTION WITHOUT PHYSICAL EXAMINATION OF FRESH PRODUCE THAT APPEARS TO HAVE BEEN PREPARED, PACKED OR HELD UNDER INSANITARY CONDITIONS

Recalls by Taiwan firms, last 5 years

15 (Class II: 15)

Recent recall reasons:

2026-08 Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
2026-08 Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
2025-09 Due to products distributed without premarket clearance or approvals.

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.