An FDA initial importer is a US importer that moves a foreign-made device toward the final seller without changing its package or label. It must register with FDA every year and handle certain safety reports, and it is a separate role from your US Agent.
Key takeaways
- FDA's files listed 5,776 active US establishments flagged as initial importers on November 2, 2026 [11].
- Initial importers pay the annual establishment fee, which is $13,785 for fiscal year 2027 [3, 12].
- 15,525 foreign establishments were registered, and 3,947 of them (25%) named no US importer in FDA's files [11].
- Annual registration runs from October 1 to December 31 [7].
- An importer must report within 30 calendar days of learning its device may have caused or contributed to a death or serious injury [8].
What is an FDA initial importer?
An initial importer is any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale to the user. It does not repackage the device or change its container, wrapper or labeling [1]. This definition is in 21 CFR 807.3(g).
FDA's web pages add practical detail. One page describes initial importers as facilities that "take first title" to an imported device [9]. Another separates them from parties "who do not take first possession", such as agents and brokers, who do not register [3]. That chart, dated 2018, also says the initial importer must have a physical US address staffed by people responsible for compliance [3].
So a simple first test is this: who first takes title to, or possession of, your device in the US, and then resells it unchanged? That company may be your US distributor or your own US subsidiary. If it changes the labeling or package, it no longer fits the definition [1]. FDA treats a relabeler as a separate activity that must register and list [3].
How is an initial importer different from a US Agent and importer of record?
These are three different jobs, under three different rule sets. One company can hold more than one, but each job has its own duties.
| Role | What it does | Rule | Registers with FDA? |
|---|---|---|---|
| US Agent | FDA's contact for a foreign establishment. Helps with communications and scheduling inspections | 21 CFR 807.40(b) [7] | Named in your registration [7] |
| Initial importer | First takes possession in the US and passes the device on to the final seller | 21 CFR 807.3(g) [1] | Yes [3] |
| Importer of record | The party that makes customs entry and answers to US Customs and Border Protection (CBP) | 19 U.S.C. 1484 [10] | Not for this role alone |
| Customs broker | Files entry data for a client | FDA's chart: agents and brokers without first possession do not register [3] | No [3] |
| US distributor that does not import | Buys from a US importer and resells | FDA's chart [3] | No [3] |
Your US Agent does not need to touch your product. The agent must live or keep a place of business in the US and must assist FDA when asked [7]. You may name only one US Agent [7]. You can read more in our US Agent guide.
Importer of record is a customs term, not an FDA term. Under US customs law, it is the owner or purchaser, or a licensed broker the owner, purchaser or consignee designates [10]. Customs has its own rules for foreign companies, so ask your customs broker. Acting as importer of record does not by itself make a company an initial importer.
In FDA's files, about 18% of the 15,525 foreign establishments have a US Agent whose business name matches a registered initial importer [11]. So some US firms appear to hold both jobs.
Do you need an initial importer to sell in the US?
You need a US Agent by rule, but FDA does not ask you to appoint an initial importer as such. The role follows the facts of your supply chain [1]. If a US company buys your device and resells it unchanged toward the final seller, that company is likely the initial importer, and it must meet the rules.
Direct shipping needs care. FDA's definition says a consumer or patient who buys the device is not an importer, unless you ship the device directly to that consumer or patient [1].
Choose this structure early. FDA registration and a US Agent are needed before commercial distribution, not before 510(k) clearance. So you can pick your importer while your 510(k) is under review, and register when you are ready to ship.
What must an initial importer do?
The core duties are registration, safety reporting and recall reporting. FDA's import page lists them [2].
| Duty | What it means | Time limit | Rule |
|---|---|---|---|
| Register | Register the US establishment | Before importing, says FDA's 2017 page. The rule says within 30 days of starting, then every year from October 1 to December 31 [7] | 21 CFR 807.20(a)(5), 807.22 [3, 7] |
| List | Submit the name and address of each manufacturer, not a full device list, unless it developed specifications or relabels. Be ready to give device names if FDA asks [3] | At registration | 21 CFR 807.20(a)(5) [3] |
| Pay the fee | $13,785 for fiscal year 2027 [12] | Each year, before registration is complete | FDA's chart [3] |
| Report deaths and serious injuries | Report to FDA and send a copy to the manufacturer | 30 calendar days of becoming aware [8] | 21 CFR 803.40 [8] |
| Report certain malfunctions | Report to the manufacturer, when a repeat would be likely to cause a death or serious injury | 30 calendar days of becoming aware [8] | 21 CFR 803.40 [8] |
| Keep MDR event files | Keep a file for each adverse event [2] | Ongoing | 21 CFR 803.18 [2] |
| Forward complaints | Send all product complaints to the manufacturer, whether reportable or not [2] | Not stated on FDA's page | FDA's import page [2] |
| Report corrections and removals | Report to FDA a correction or removal the importer starts, to reduce a health risk or remedy a violation that may present one | 10 working days of starting it [4] | 21 CFR 806.10 [4] |
| Track devices | Only for devices subject to tracking orders [2] | As required | 21 CFR 821 [2] |
FDA's import page does not list a quality system among initial importer duties [2]. Your duties as the foreign manufacturer stay with you. They include registration, listing, your quality system, premarket review, labeling and adverse event reporting [2].
Use our fee calculator to see the current FDA fees for each submission type.
The renewal window is open now. On November 2, 2026, 4,591 of the 5,776 active initial importers (79%) still showed an expiry year of 2026 in FDA's file [11]. Ask your importer to confirm its renewal before December 31.
Does FDA issue an import permit for medical devices?
No FDA import permit or import license appears in FDA's import requirements for devices. We searched FDA's import page and 21 CFR Part 807 and found none [2]. Entry filings carry your registration and listing numbers instead [5]. Radiation-emitting products have a separate declaration, Form FDA 2877 [2].
The importer or customs broker files entry data with CBP through the Automated Commercial Environment (ACE). That data includes the importer's product description, manufacturer, shipper, country of origin, FDA product code and any affirmation of compliance codes [2]. For a medical device, the filer must also give the registration number and the device listing number [5].
FDA verifies requirements when a device is imported or offered for import [2]. Products that do not meet FDA's requirements may be detained at entry [2]. See our registration and listing guide for what those numbers are and how to check them.
Do you have to tell FDA who imports your device?
Yes. Each foreign establishment must identify its known importers at initial registration, every year, and whenever something changes [6]. This rule is 21 CFR 807.41.
Two groups are in scope [6]:
- Importers: a US company or person that is an owner, consignee or recipient of your device, even if not the first one.
- Persons who import or offer for import: agents, brokers or other parties you use to help with import. Carriers are excluded.
You must also say which of your listed products each importer receives [6]. FDA publishes these links in its weekly download files [11]. So your importer is visible in public data.
We counted how foreign establishments report this. The table shows active registrations on November 2, 2026, for selected markets [11].
| Country | Foreign establishments | Listed in FDA's registered importer file | Name no importer at all |
|---|---|---|---|
| All countries | 15,525 | 10,069 (65%) | 3,947 (25%) |
| South Korea | 894 | 426 (48%) | 333 (37%) |
| Japan | 530 | 429 (81%) | 64 (12%) |
| Taiwan | 622 | 430 (69%) | 137 (22%) |
| India | 388 | 211 (54%) | 134 (35%) |
| Malaysia | 254 | 196 (77%) | 40 (16%) |
| Turkey | 92 | 52 (57%) | 30 (33%) |
| UAE | 14 | 10 (71%) | 2 (14%) |
| Saudi Arabia | 3 | 0 (0%) | 3 (100%) |
A blank does not prove a problem. A contract manufacturer or sterilizer may ship to a foreign firm, not to a US importer. Also, 918 of the 3,947 are named by an importer in FDA's separate file. But if you ship to the US and your entry is blank, fix it during your annual registration. FDA's rule says "known to the foreign establishment", so a known importer belongs in your record [6].
What do international manufacturers get wrong?
Many errors come from mixing up the three roles. Check these first.
- Assuming your US Agent is your importer. The agent's duties under 21 CFR 807.40 do not include taking your goods [7].
- Assuming your customs broker is your importer. A broker that does not take first possession does not register [3]. You must still name it under 21 CFR 807.41(b) [6].
- Letting the importer add a label without a plan. A company that changes the content of your labeling for its own name becomes a relabeler [3]. It then has listing duties, and more of FDA's manufacturer rules may apply to it.
- Forgetting safety report routes. Your importer needs a named contact at your company, so complaints reach you. You keep your own reporting duties as manufacturer [2].
- Treating registration as approval. Registration does not denote approval of the establishment or its products, and any impression that it does is misbranding [7].
What should your importer agreement cover?
Put the safety duties in writing, because FDA's time limits apply to each party. Your agreement should cover at least these points:
- The importer's FDA registration number, and proof of renewal each year.
- Who receives complaints at your company, and how fast the importer must forward them [2].
- Who reports what to FDA, so nobody misses a 30-day limit [8].
- How you run a correction or removal together, given the 10-working-day limit [4].
- A rule against label or package changes without your written approval [1].
What should you do next?
Map your supply chain on one page, then assign each role by name. This shows gaps before your first shipment.
- Confirm your device's status: exempt, 510(k) cleared, De Novo granted or PMA approved.
- Name your US Agent.
- Decide who takes first possession in the US.
- Ask that company for its FDA registration number, and check it in FDA's public database.
- Name your importer and any broker in your own registration [6].
- Agree in writing who sends complaints, safety reports and recall notices, and to whom.
Complizen acts as your US Agent and handles establishment registration and device listing. It does not act as your initial importer. If you are planning your first US shipment, tell us which devices and markets you are targeting. Our international path sets out the full route from here.
How we counted
We used FDA's establishment registration and listing download files, updated weekly, as downloaded on November 2, 2026 [11]. We counted Registration.txt rows with status code 1, which we read as active, and address type F (facility). This gave 28,625 establishments: 15,525 outside the US and 13,100 in the US. All 5,776 initial importer flags were on US establishments.
"Listed in FDA's registered importer file" means the establishment appears in FDA's file of registered importers identified by manufacturers. Of the 10,069, 550 link only to an importer without an active registration today. "Name no importer at all" means it also has no entry in the non-registered importer file. Country is the establishment's address. We matched US Agent and initial importer names after lowercasing and removing punctuation, so a true link under a different name will not appear.
We read the file's expiry year as the fiscal year of the last annual registration. FDA does not define these two fields on its download page.
Frequently asked questions
What is an initial importer in FDA terms?
An initial importer is an importer that moves a device from a foreign manufacturer toward the final seller, without repackaging or relabeling it. The definition is in 21 CFR 807.3(g). FDA also says it must have a staffed physical address in the United States.
Does an initial importer have to register with FDA?
Yes, FDA's chart says an initial importer must register and pay the annual establishment fee. It does not submit a full device list. It can meet its listing duty by giving the name and address of each manufacturer, unless it developed the specifications or relabels.
How much is the FDA initial importer registration fee?
The annual establishment registration fee is $13,785 for fiscal year 2027, from October 1, 2026. FDA's chart says initial importers pay this fee. FDA changes the amount each fiscal year, so check the current user fee notice before you budget for it.
Is an initial importer the same as an importer of record?
No, these terms come from different laws. Initial importer is an FDA term about who first takes title or possession of the device in the US and resells it. Importer of record is a customs term about who makes entry with CBP. One company can hold both roles, but it does not have to.
Is a US Agent the same as an initial importer?
No, a US Agent is a contact for FDA and does not need to handle your product. An initial importer takes possession and moves the device toward the seller. A single US firm can do both, but those are separate jobs with separate duties.
Can my US Agent also be my initial importer?
Yes, the rules we reviewed do not prevent one company from doing both jobs. In FDA's files, about 18% of foreign establishments have a US Agent whose name matches a registered initial importer. Check that the company accepts both sets of duties in writing.
Can a foreign manufacturer be its own initial importer?
Not without a US presence, because FDA's registration chart says an initial importer needs a staffed physical US address. That line is on FDA's web page, not in the definition. A US subsidiary or US distributor can take this role. Customs rules are separate.
Does a customs broker need to register with FDA?
No, FDA's chart says import agents, brokers and other parties that do not take first possession do not register, list or pay the fee. However, if you are a foreign establishment, you must still name them in your own registration under 21 CFR 807.41.
What are an initial importer's reporting duties?
An importer must report deaths and serious injuries to FDA and the manufacturer within 30 calendar days. It must report certain malfunctions to the manufacturer in the same time. It must also report certain corrections and removals to FDA within 10 working days.
Does an initial importer need a quality system under 21 CFR 820?
FDA's import page lists registration, medical device reporting, corrections and removals, and tracking, not a quality system. But the QMSR, in effect since February 2, 2026, has scope wording on some distributors of foreign entities. Check it against your exact activities.
Do I need a 510(k) before I appoint an initial importer?
No, you can agree the role at any time, but the device must be legally marketed before commercial import. That means exempt, 510(k) cleared, De Novo granted or PMA approved. US registration and a US Agent are needed before commercial distribution, not before 510(k) clearance.
What happens if my importer relabels my device?
It becomes a relabeler, which FDA requires to register and list. FDA says a company that only adds its own name without changing the original labeling is not a relabeler. Agree on any label change with your importer first, and review it for FDA compliance.
References
- 21 CFR 807.3, Definitions, paragraphs (g), (x) and (y) (2025 edition). https://www.govinfo.gov/content/pkg/CFR-2025-title21-vol8/pdf/CFR-2025-title21-vol8-sec807-3.pdf
- FDA. Importing Medical Devices and Radiation-Emitting Electronic Products into the U.S. Content current as of January 30, 2026. https://www.fda.gov/medical-devices/importing-and-exporting-medical-devices/importing-medical-devices-and-radiation-emitting-electronic-products-us
- FDA. Who Must Register, List and Pay the Fee. Content current as of September 27, 2018. https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee
- 21 CFR 806.10, Reports of corrections and removals (2025 edition). https://www.govinfo.gov/content/pkg/CFR-2025-title21-vol8/pdf/CFR-2025-title21-vol8-sec806-10.pdf
- 21 CFR 1.76, Medical devices, data for ACE entry filing (2025 edition). https://www.govinfo.gov/content/pkg/CFR-2025-title21-vol1/pdf/CFR-2025-title21-vol1-sec1-76.pdf
- 21 CFR 807.41, Identification of importers and persons who import or offer for import (2025 edition). https://www.govinfo.gov/content/pkg/CFR-2025-title21-vol8/pdf/CFR-2025-title21-vol8-sec807-41.pdf
- 21 CFR Part 807, including sections 807.22, 807.39 and 807.40 (2025 edition). https://www.govinfo.gov/content/pkg/CFR-2025-title21-vol8/pdf/CFR-2025-title21-vol8-part807.pdf
- 21 CFR 803.40, importer reporting requirements (2025 edition). https://www.govinfo.gov/content/pkg/CFR-2025-title21-vol8/pdf/CFR-2025-title21-vol8-sec803-40.pdf
- FDA. How to Register and List. Content current as of August 23, 2018. https://www.fda.gov/medical-devices/device-registration-and-listing/how-register-and-list
- 19 U.S.C. 1484, Entry of merchandise (2023 edition). https://www.govinfo.gov/content/pkg/USCODE-2023-title19/html/USCODE-2023-title19-chap4-subtitleIII-partIII-sec1484.htm
- FDA. Establishment Registration and Medical Device Listing Files for Download, updated weekly, downloaded November 2, 2026. https://www.fda.gov/medical-devices/device-registration-and-listing/establishment-registration-and-medical-device-listing-files-download
- FDA. Medical Device User Fee Rates for Fiscal Year 2027. 91 FR 48134, July 30, 2026. https://www.federalregister.gov/documents/2026/07/30/2026-15335/medical-device-user-fee-rates-for-fiscal-year-2027