Establishments that make, process or export devices for the US must register with FDA every year, list their devices and, if foreign, name a US agent. When a device is imported, the entry must carry the manufacturer's registration number and the listing number, and FDA flags entries whose numbers do not match.
Key takeaways
- Pay the annual fee first, then register: for fiscal year 2027 the establishment registration fee is $13,785, and renewal runs from October 1 to December 31.
- No device may be imported unless it is listed and made at a registered foreign establishment, except devices for clinical investigations.
- At entry, the filer declares the manufacturer's registration, the exporter's registration and the listing number, plus the 510(k) number where one applies.
- FDA does not issue registration certificates, and registration does not mean FDA approved your company or your device.
- We analyzed FDA's 2026 registration files: more than 15,500 foreign establishments are registered, including 894 in South Korea, and 5,785 US establishments are registered as initial importers.
What are FDA registration and listing?
Two separate filings in one system. Registration tells FDA where an establishment is and what it does. Listing tells FDA which devices it makes or handles [1]. Both are filed electronically, in English for foreign establishments [3].
Registration is not approval. Registering, or holding a registration number, "does not in any way denote approval of the establishment or its products" [2]. Any claim that suggests official approval because of registration is misbranding [2].
There is no FDA registration certificate. FDA does not issue registration certificates, and does not certify the information that establishments file. It says its database entry does not denote approval, clearance or authorization [4]. Anyone can check an establishment in FDA's public registration and listing database [11].
Who must register and list?
Anyone who makes, prepares, assembles or processes a device for human use [1]. The rule also covers anyone who [1]:
- develops specifications for a device made by someone else
- manufactures or sterilizes a device for another company
- repackages or relabels a device
- reprocesses a single-use device
- acts as the initial importer
- makes components or accessories packaged or labeled for a health-related use
Initial importers register but list differently. They can meet their listing duty by naming the manufacturer, and they pay the registration fee [1, 10]. Foreign exporters, which ship a device to the US without making it, must register, list and pay [10].
Wholesale distributors do not register, as long as they do not manufacture, repackage, process or relabel the device [1, 10]. So your distributor's status says nothing about yours: your own establishment must be registered.
We analyzed FDA's registration files, dated September 21, 2026, and counted the roles that foreign establishments register under [9]. An establishment can hold more than one role.
| Establishments in | Total | Manufacturer | Contract manufacturer | Foreign exporter |
|---|---|---|---|---|
| South Korea | 894 | 790 | 126 | 93 |
| Taiwan | 624 | 492 | 230 | 213 |
| Japan | 533 | 337 | 159 | 107 |
| India | 388 | 297 | 135 | 43 |
| Malaysia | 254 | 143 | 148 | 36 |
| Turkey | 92 | 77 | 23 | 18 |
Malaysia is the only market here with more contract manufacturers than manufacturers registered [9]. We measured the foreign exporter role across all countries: 4,020 foreign establishments, about 26%, are registered as foreign exporters [9]. Import entries include the exporter's registration number as well as the manufacturer's [7].
When do you register, and what does it cost?
Register within 30 days of starting an operation, and list your devices at the same time [1]. A foreign establishment must be registered, and its device listed, before the device is imported [3].
Renew every year. Annual registration runs from October 1 to December 31. In the same window, you must review and confirm your listings, even if nothing changed [1]. Update registration details within 30 days of a change [1].
Pay first, then register. For fiscal year 2027, the annual establishment registration fee is $13,785 per establishment [8]. You order and pay through FDA's user fee system, receive a payment identification number and a payment confirmation number, and cannot register without both [8]. An establishment that must pay is not legally registered until it has paid and registered [8].
The registration fee has a single rate, with no small business discount [8]. FDA may, but is not required to, waive it for a small business with $1 million or less in gross receipts, if paying would be a financial hardship [8]. The waiver never covers an initial registration [8]. See our guide to FDA's small business determination.
For the screens and fields, follow our step-by-step guide to registering in FDA's system.
What does a foreign manufacturer need?
Three things, before the first shipment [3]:
- A registered establishment for each foreign site that makes, processes or exports the device [3, 10].
- A device listing for each device, carrying its product code and, where one applies, its 510(k) number [5].
- One US agent, named in the registration. The agent must live or keep a place of business in the US and helps FDA communicate with you [3]. An official correspondent handles registration matters with FDA, and the US agent may also act as the official correspondent [3].
The law is direct: no device may be imported unless it is listed and made at a registered foreign establishment [3]. The only exception is for devices imported for clinical investigations under 21 CFR Part 812 [3].
The consequence is refusal at the border. Under the law, a device made in an establishment that is not registered, or not included in a listing, is misbranded [12]. Imported devices that appear misbranded are refused admission [12].
Our FDA US agent guide explains how to choose an agent.
What do FDA and customs check when your device arrives?
The numbers on the entry. To screen device imports, FDA's PREDICT system needs accurate product codes, the relevant affirmations of compliance and accurate company identifiers [5]. Affirmations of compliance are coded data fields the entry filer declares [6]:
| Code | What it declares |
|---|---|
| DEV | Foreign manufacturer's registration number |
| DFE | Foreign exporter's registration number |
| LST | Device listing number |
| PM# | Premarket number, such as the 510(k) number |
| DI | Device identifier, part of the unique device identifier |
For a standard import of a finished device, FDA's import training lists DEV, DFE and LST as mandatory, and PM# where it applies [7].
We reviewed FDA's list of common device entry errors. These are the ones tied to registration and listing [5]:
- No listing number, or one FDA cannot find.
- A product code that does not match the product code on the listing.
- A premarket number that does not match the one on the listing.
- No registration number for the foreign manufacturer. If your registration number is not yet assigned, FDA says the owner/operator number may be given until it is [5].
Our guide to FDA import refusals covers what happens after a problem.
What should you give your US importer?
The numbers the entry needs, because they can only get some of them from you. FDA says there is no public website to search listing numbers, which are proprietary, and FDA will not confirm them for anyone except the firm's official correspondent [5].
Give your importer or customs broker:
- Your registration number, and your exporter's, if a separate company ships the device
- Your device listing number for each device
- The product code that matches each listing
- Your 510(k) number, or confirm that the device is 510(k) exempt
- Your US agent's name and contact details
Buyers can check your registration themselves. FDA's public database shows registered establishments and their listed devices [11]. That, not a certificate, is what proves registration [4].
What mistakes cause problems?
- Buying or showing an "FDA registration certificate." FDA does not issue them, and using registration to imply approval is misbranding [2, 4].
- Assuming your distributor registers for you. Wholesale distributors are not required to register [1].
- Missing the renewal window. Registration must be renewed between October 1 and December 31 every year [1]. A device from an establishment that is not registered is misbranded [12].
- Mismatched numbers. A product code or 510(k) number that differs from your listing gets the entry flagged [5].
- Stale listings. You must review and confirm every listing during the annual window [1].
- Believing you must hire someone. FDA does not require firms to hire anyone to register, and firms offering registration help are not affiliated with FDA [4].
If you would rather hand the work over, Complizen handles establishment registration, device listing and US agent service for manufacturers outside the US. Our International Track covers the full sequence for entering the US.
Frequently asked questions
What is the difference between FDA registration and listing?
Registration identifies your establishment: where it is, who owns it and what it does. Listing identifies the devices your establishment makes or handles, each with its product code. You need both, and you file both electronically through FDA's registration and listing system.
Does FDA registration mean my device is approved?
No. Registration, or holding a registration number, does not denote FDA approval of your establishment or your products. Using registration to create an impression of official approval is misbranding. Your device's premarket status comes from its 510(k), De Novo or PMA, or from an exemption.
Does FDA issue a registration certificate?
No. FDA does not issue registration certificates to device establishments, and it does not certify the information they file. Documents sold as "FDA registration certificates" are not FDA documents. Your registration can be checked in FDA's public registration and listing database.
How much does FDA registration cost in 2027?
For fiscal year 2027, which runs from October 1, 2026 to September 30, 2027, the annual establishment registration fee is $13,785 per establishment. There is no small business discount. You pay first, then use your payment numbers to complete the registration.
When must I renew my FDA registration?
Every year between October 1 and December 31. During the same window, you must review and confirm all your device listings, even if nothing changed. An establishment that must pay the fee is not legally registered until it has paid and completed registration.
Do foreign manufacturers need to register before shipping?
Yes. No device may be imported into the US unless it is listed and made at a registered foreign establishment. The only exception is for devices imported for clinical investigations. The foreign establishment must also name a US agent. A device from an unregistered establishment is misbranded, and misbranded imports are refused admission.
Does my US distributor need to register with FDA?
Not usually. Wholesale distributors that do not manufacture, repackage, process or relabel a device are not required to register. The initial importer, which brings your device into the US and furthers its sale, must register and pay the fee, but can list by naming you.
What numbers does customs need for a medical device import?
For a standard import, FDA's import training lists the foreign manufacturer's registration number, the foreign exporter's registration number and the device listing number as mandatory. The premarket number, such as the 510(k) number, is required where one applies. Filers must also give accurate product codes, which FDA checks against your listing.
Why was my device shipment flagged by FDA?
FDA's list of entry errors includes a missing or unknown listing number, and a product code or 510(k) number that does not match the listing. A missing registration number for the foreign manufacturer is another. FDA's screening system relies on these entry data, so complete and accurate numbers help an entry clear.
Can my importer look up my device listing number?
No. FDA says there is no public website to search listing numbers, because they are proprietary. FDA will confirm them only for the firm's official correspondent. Give your listing numbers to your importer or customs broker directly. They can find your official correspondent's contact details in FDA's public registration database.
Do I have to hire a company to register with FDA?
No. FDA does not require firms to hire anyone to complete the online registration, and firms offering registration help are not affiliated with FDA. Some manufacturers still use a service provider, especially when they also need a US agent. Either way, the registration is filed in FDA's online system for the establishment's owner or operator.
How many foreign medical device establishments are registered with FDA?
More than 15,500, in FDA's registration files dated September 21, 2026. They include 894 establishments in South Korea, 624 in Taiwan, 533 in Japan, 388 in India, 254 in Malaysia and 92 in Turkey. In the US, 5,785 establishments are registered as initial importers.
References
- eCFR. 21 CFR 807.20, Who must register and submit a device list, and 21 CFR 807.22, Times for establishment registration and device listing. Accessed September 26, 2026.
- eCFR. 21 CFR 807.39, Misbranding by reference to establishment registration or to registration number. Accessed September 26, 2026.
- eCFR. 21 CFR 807.40, Registration and listing for foreign establishments. Accessed September 26, 2026.
- FDA. Important Reminders about Registration and Listing. Content current as of March 3, 2021.
- FDA. Medical Device Common Entry Errors. Content current as of November 25, 2025.
- FDA. FDA Affirmations of Compliance for the Automated Commercial Environment. March 10, 2026.
- FDA. Importation of FDA Regulated Medical Devices: Required Information. Office of Enforcement and Import Operations training, July 13, 2022.
- Federal Register. Medical Device User Fee Rates for Fiscal Year 2027, 91 FR 48134. Published July 30, 2026.
- FDA. Establishment Registration and Medical Device Listing Files for Download, files dated September 21, 2026.
- FDA. Who Must Register, List and Pay the Fee. Accessed September 26, 2026.
- FDA. Establishment Registration and Device Listing database. Accessed September 26, 2026.
- US Code. 21 U.S.C. 352(o) (misbranding of devices from unregistered establishments) and 21 U.S.C. 381(a) (refusal of admission). Accessed September 26, 2026.