21 CFR 807.40

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

A medical device establishment in India 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 5,683 import lines from India, and 58 FDA import alerts list firms from India.

FDA data for India

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	5,683
Refusals citing registration or listing problems	NOT LISTED-118 · 907

Most common refusal charges

Code	Count
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).	3260
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…	907
FILTHY-249 The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise un…	563
MFR INJ-3821 The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that such article appears to have been prepared, packed, or held …	549
MFR INSAN-308 The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.	518

Import alerts listing India firms

Import alerts that list at least one firm in India: 58. Recently updated:

Import Alert 16-129: Detention Without Physical Examination of Seafood Products Due to Nitrofurans
Import Alert 45-02: Detention Without Physical Examination and Guidance of Foods Containing Illegal and/or Undeclared Colors.
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
Import Alert 99-19: Detention Without Physical Examination of Food Products Due to the Presence of Salmonella
Import Alert 99-42: DETENTION WITHOUT PHYSICAL EXAMINATION OF FOODS DUE TO HEAVY METAL (TOXIC ELEMENT) CONTAMINATION

Recalls by India firms, last 5 years

10 (Class I: 6, Class II: 4)

Recent recall reasons:

2025-10 Carescape Central Station (CSCS), software version V3.0.5, can cause the system to enter a continuous reboot cycle. If this occurs, a loss of central monitorin…
2024-10 GE HealthCare has become aware that complete electrical safety testing was not conducted during manufacturing of certain Giraffe and Panda iRes Warmers. There …
2024-02 GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR Incubat…

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.