By Richie Lin    Photo：CANVA

A Taiwanese manufacturer of infusion sets spends two years and a meaningful amount of money getting a 510(k) clearance. The clearance letter arrives. The first order comes in from a US distributor. The goods ship. And then the entry sits at the Port of Los Angeles under an FDA hold for eleven days, because the manufacturer’s registration number was entered in the wrong field, the product code filed cannot be correctly matched to the device listing and marketing clearance, and nobody on either side of the Pacific can say who is responsible for fixing it.

These shipping problems are not unusual. For Asian medical device companies entering the United States for the first time, unclear responsibilities can become an early obstacle. The cause often traces back to the same root: the company treated "getting into the US market" as a regulatory project, when it is equally an entity project. Before a single carton moves, someone has to be the Importer of Record. Someone has to be the FDA Initial Importer. Someone has to be the US Agent. Those are three different roles under customs and FDA rules, carrying three different sets of responsibility, and they are frequently, and wrongly, assumed to be the same thing.

Getting this structure right is not administrative housekeeping. It determines who holds the customer relationship, who absorbs the tariff exposure, whose name appears on a public refusal record, and whether you are building a US business or simply selling FOB to someone who is building one.

Three roles, distinct legal responsibilities

1. The Importer of Record (IOR) is responsible for the customs entry: classification, declared value, origin and payment of duties. There are legal limits on who can take the role, generally the owner, purchaser or a properly designated licensed customs broker. Hiring a broker to file the entry does not remove the IOR’s responsibility for the information. CBP focuses on customs requirements; FDA checks the device’s marketing status and product compliance. Both agencies have a part in import enforcement.

2. The FDA Initial Importer brings the foreign manufacturer’s device into the US distribution chain, supplying the party that makes the final delivery or sale to the user. This role does not repackage the device or change its container, wrapper or labeling. A firm that also performs those activities needs to assess its additional regulatory roles. The initial importer needs a physical US business address and staff responsible for compliance, and must register with FDA each year. Complaint handling, adverse event reporting and relevant records are real responsibilities after import.

3. The US Agent is the foreign establishment’s contact with FDA. Every foreign establishment required to register must appoint one. The agent must reside in the United States or maintain a physical business location there; a post office box or answering service alone is not enough. The agent helps with FDA questions, communications and inspection scheduling. If FDA cannot contact the foreign establishment directly or promptly, information or documents provided to the US agent are treated as having been provided to that establishment. The agent needs to pass on the notice promptly so the firm can respond. The role itself does not include the duties of an IOR or initial importer, or automatically make the agent responsible for the manufacturer’s adverse event reports.

These three can be the same entity. They very often are not. A foreign manufacturer can be its own IOR. A foreign manufacturer cannot be its own FDA initial importer, because the initial importer must be a domestic establishment. Your US agent may be a consultancy that has never touched your goods and has no customs authority whatsoever. Treating any of these as interchangeable is where the trouble starts.

What the Importer of Record actually signs up for

Whoever is named as IOR takes on more than a filing duty. They take on:

Classification and valuation liability. The HTS code determines the duty rate, and the declared value determines the amount. Both are legal responsibilities of the IOR and must meet the standard of "reasonable care." Misclassification cannot simply be dismissed as a typo; it may lead to penalties under 19 USC 1592. The limitation period is generally five years from the alleged violation; for fraud, it runs from discovery of the fraud.

The customs bond. Formal commercial entries generally require a customs bond, arranged as a single transaction or continuous bond. A standard import continuous bond is generally based on ten percent of duties, taxes and fees for the previous twelve months, with a usual minimum of US$50,000. New importers and significant changes in duty exposure require estimates and adjustments under CBP’s requirements. When tariffs jump, and for Chinese origin medical goods they have jumped sharply, the required bond amount jumps with them, and an insufficient bond can stop your entries cold. Foreign entities acting as nonresident importers face additional requirements, including a resident agent for service of process, and surety companies price that risk accordingly.

Post entry exposure. Duty is not final at the border. Entries liquidate later, and CBP can issue rate advances, demand supplemental duty, or open a penalty inquiry long after your goods have been sold and the cash collected.

For an Asian exporter entering the market for the first time, the instinct is often to say: let the US distributor be IOR, it's simpler. Sometimes that is exactly right. But understand the trade you are making. If your distributor is the IOR, your distributor controls the import data. They see the landed cost structure. They own the CBP relationship. And if they later drop your line, you will need to establish the IOR, bond and broker arrangements for the next partner if you have never built your own import structure or secured access to the relevant data. Whether product clearances, customer information and commercial records remain available depends on who holds them and what the contract provides.

What the FDA Initial Importer actually signs up for

This is the role most Asian manufacturers underestimate, because the registration itself looks trivial. It is a short online submission. What follows it is not trivial.

Annual registration and fee. The initial importer must register with FDA and pay each year. For FY2027, from 1 October 2026 to 30 September 2027, the fee is US$13,785 per establishment, not per product. Certain qualifying small businesses demonstrating financial hardship may obtain an annual fee waiver; initial registration is excluded. Check the current figure and include it in the budget.

Note what registration is not. Registration is not clearance, approval, or endorsement. FDA is explicit that a firm may not use its registration number, or the fact of registration, to suggest that FDA has approved the device. Using "FDA Registered" on a brochure or an Amazon listing to imply FDA approval or endorsement of the product creates a compliance problem. Asian manufacturers make this mistake constantly, usually in good faith.

Device listing, but not by the importer. Initial importers register, but are generally not required to submit device listing information; listing is the obligation of the manufacturer or specification developer. This split confuses people who assume registration and listing travel together. They do not.

Medical Device Reporting. Importers and manufacturers have separate reporting duties. If an importer receives information reasonably suggesting that a device may have caused or contributed to a death or serious injury, it must report to FDA and send a copy to the manufacturer. Information reasonably suggesting a malfunction likely to cause or contribute to death or serious injury if it recurs must be reported to the manufacturer. Both require action as soon as practicable, no later than 30 calendar days after becoming aware of the relevant information. Agree in advance who receives complaints and assesses reporting. An incident is a poor time to start looking for an owner.

Complaint files and records. Importers need MDR event files, complaint handling records and relevant distribution records, and must forward product complaints to the manufacturer for evaluation. If FDA asks, the records should show when the information arrived, who handled it, how the reporting decision was made and where the relevant products went.

The Quality Management System Regulation (QMSR), aligned with ISO 13485, took effect on 2 February 2026. FDA’s current inspection instructions require initial importers and distributors to meet the QMSR requirements applicable to their operations. A firm that does not perform design and development does not need to meet design and development requirements. It should document why any requirements do not apply. If the manufacturer takes primary responsibility for complaints or MDR work, a signed quality agreement should set out responsibilities, record keeping and access to records. If your US partner still uses procedures built around the old QSR, ask whether complaint handling, records and responsibilities have been reviewed against current requirements.

Corrections and removals. A complaint may lead to revised labeling, customer notifications, repairs or removal of products from the market. If the importer initiates a correction or removal to reduce a health risk, or to remedy a violation that may present a health risk, a report is due within ten working days when FDA’s reporting criteria apply. Corrections and removals that do not meet the reporting threshold still require records under the applicable rules. Certain devices also have tracking requirements.

Inspection. Initial importers are FDA inspectable establishments. An investigator can and does turn up at the importer's premises, ask for complaint files, MDR decision records, distribution records, and evidence that the devices being imported are cleared and correctly labeled.

The practical consequence: whoever you name as initial importer is taking on real postmarket liability. Do not hand that role to a warehouse or a freight agent who does not understand what it carries, and be equally wary of anyone who offers to be your initial importer for a token monthly fee without asking you a single question about your complaint handling.

What FDA expects from you, the foreign manufacturer

Your obligations do not disappear because someone else imports. As a foreign establishment exporting devices to the United States, you must:

• Register your establishment with FDA annually and pay the fee. Foreign manufacturers pay the same establishment fee as domestic ones.
• List your devices, with the correct product codes.
• Designate a US agent with a genuine US physical presence.
• Hold the right marketing authorization, a 510(k) clearance, a De Novo grant, a PMA approval, or a documented determination that your device is exempt. Exempt does not mean unregulated; most exempt devices remain subject to registration, listing, labeling and general controls.
• Meet applicable Unique Device Identification (UDI) and Global Unique Device Identification Database (GUDID) requirements if you are the labeler.
• Meet the applicable Quality Management System Regulation (QMSR) requirements, and fulfil your own duties as manufacturer for adverse event reporting, corrections and removals.
• Label correctly, including the name and place of business of the manufacturer, packer or distributor, and applicable instructions and warnings. Prescription devices must follow their specific labeling requirements.

One structural point that catches many Asian companies: an own brand or OEM model affects who manages specifications, labeling and marketing documents, but the brand name alone does not determine the regulatory roles. Identify the specification developer, UDI labeler and clearance or approval holder from the actual activities, application records and commercial arrangements. Where a US customer develops the specifications and holds the clearance, the core marketing documents typically remain under that customer’s control. Before launching your own brand, establish whether the existing clearance supports the new arrangement and whether a new submission is needed. A different brand name does not resolve those questions. That decision is worth making deliberately and early, not by drift.

What actually happens at the border

When your shipment arrives, two parallel processes run. CBP processes the customs entry. FDA uses the manufacturer, initial importer, product code and compliance information transmitted by the broker to check registration, listing and marketing authorization. The manufacturer and US partner should verify that information before shipment and provide it to the broker. The three letter device classification code and the longer FDA import product code serve different purposes and must correspond correctly.

FDA’s screening produces several outcomes. May Proceed allows the entry to continue through the import process. FDA Review or Hold means further review or action is pending. Read a Notice of FDA Action for the specific action and response required. A Detention and Hearing notice gives you a deadline to submit evidence of compliance. Following Refusal, goods generally must be exported or destroyed under FDA and CBP supervision within 90 days of the notice.

One category of hold is well suited to prevention before shipment: registration information entered against the wrong entity or field, an import product code that does not correspond to the device records, a missing required affirmation of compliance, or an initial importer lacking the required registration. Checking those fields is straightforward. Missing registrations or marketing authorizations need separate lead time. After arrival, terminal charges, demurrage and detention can accumulate while the problem is resolved.

Two further mechanisms deserve attention. Import Alerts allow FDA to detain covered products without physical examination. The importing party must then provide evidence that the shipment complies. Release of one shipment does not remove the alert. An alert may concern a particular firm, a product category or an origin.

The Import Refusal Report is public and searchable. Future US partners and their auditors can find refusal records for the relevant firms and products. The consequences can reach beyond the shipment and into the next commercial discussion.

Four structures, and what each one really costs you

There is no universally correct answer here. There is a correct answer for your stage, your margin, and your ambition.

Structure 1: Your US distributor is both IOR and initial importer.

Usually simpler to start, with less fixed investment. You sell FOB or FCA, and transport risk transfers at the agreed delivery point: on board the nominated vessel under FOB, or upon the agreed delivery at the named place under FCA. Your FDA obligations as manufacturer remain. Without agreed access to import data and customer relationships, you may see the factory selling price but have limited visibility into landed cost and the end market. If the distributor underperforms or walks away, new import and distribution arrangements will need to be established. Appropriate for testing the market. Dangerous as a permanent state.

Structure 2: You establish a US subsidiary that is both IOR and initial importer.

Maximum control. You see the real landed cost, you own the customer relationships, you can supply multiple distributors and ecommerce channels. Control of the product’s regulatory documents and marketing authorizations must be arranged separately. The cost is real: entity formation, a US address and staff, bond, registration fees, insurance, and genuine capability in MDR and complaint handling. This is the structure for a company that has decided the US is a strategic market rather than an opportunistic one.

Structure 3: You act as nonresident IOR; a US partner acts as initial importer.

A hybrid that keeps the customs relationship and landed cost visibility with you while a qualified US entity handles the initial importer’s postmarket obligations. The foreign manufacturer retains its own obligations. Workable, but it requires that both parties clearly understand which obligations sit where, in writing. The failure mode is each side assuming the other is handling MDR.

Structure 4: A third party IOR service.

Available, and sometimes the only short term option. Approach with caution. Ask what qualifies the provider to act as IOR: a financial interest in the transaction as owner or purchaser, or properly designated licensed customs broker status? Simply lending a name may not meet the requirements. Then establish who handles document corrections, additional duty and indemnity if something goes wrong. The monthly price alone will not answer those questions.

The layer nobody can ignore any more: tariffs and origin

For Chinese origin medical goods, the Section 301 environment has changed the arithmetic fundamentally. Rates on certain medical products, syringes and needles most dramatically, with gloves and face masks on published step up schedules, have moved to levels that can exceed the product's own margin. Rates and effective dates have been revised more than once; verify the current rate for your specific HTS subheading rather than relying on any figure, including ones in this article.

As of October 2026, origin comparisons must also account for the Section 301 forced labor measure effective from 24 July 2026 and its product exemptions. Covered Vietnamese and Thai products generally face an additional 12.5%. For covered Taiwanese products, this duty fills the gap between the ordinary tariff and 10%; no duty under this measure is added when the ordinary tariff is already at least 10%. Other applicable duties still need to be included. This is not a cap on every Taiwanese product’s total duty burden.

Compare origins using the same product’s tariff classification, exemptions and full applicable duty burden. Two country percentages alone do not give you the landed cost.

Three consequences follow.

First, establish the correct classification before making the commercial decision. Apparently similar products can fall under different subheadings, affecting margin and selling price. The code follows the product’s characteristics and tariff rules. You cannot choose the lower rate simply because it suits the business case.

Second, origin must be substantiated, not asserted. Manufacturers in Vietnam, Thailand and Taiwan have opportunities to win orders as buyers diversify away from China, but moving final assembly to Vietnam does not automatically confer Vietnamese origin. Substantial transformation is a factual test, and CBP has been actively examining transshipment. If your origin claim cannot survive a documentary audit, bills of materials, production records, process descriptions, you are carrying a contingent liability that can disrupt shipments and cash flow when an origin claim is challenged.

Third, sourcing across several countries makes data coordination harder. For companies diversifying their origins, a process built for shipments from one province may no longer be adequate. Four origins means four sets of production schedules, four sets of documentation standards, four sets of lot and expiry records, and four opportunities for the entry data to be wrong.

A sequence that works

For an Asian manufacturer starting from zero, the order matters more than the speed.

1. Decide the brand question first. Own brand or OEM. Establish who will control specifications, labeling and marketing documents.

2. Confirm your regulatory pathway, exempt, 510(k), De Novo, PMA, and confirm the product code. Do this before tooling, not after.

3. Classify the product for customs and model the landed cost at current tariff rates, including origin scenarios. If the economics do not work at today's rates, no amount of regulatory progress will fix that.

4. Register the establishment, list the devices, appoint a real US agent.

5. Decide the import structure from the four above, explicitly, in writing, with the obligations allocated clause by clause.

6. Build the data discipline before the first shipment. Purchase order, item, quantity, cartons, volume and weight must reconcile across packing list, invoice, booking and bill of lading, allowing for the different scope of each document; applicable lot numbers and expiry dates must be captured at source, not reconstructed later; and the FDA entry data must be verified against your registration and clearance records before departure, not after arrival.

7. Then ship. And keep a record of every entry, because your import history is an asset that compounds.

The point behind the paperwork

It is tempting to treat all of this as compliance overhead, a tax on doing business in the United States, to be minimised and delegated. That view is expensive.

The structure you choose affects who holds the import data, who sees the landed cost and which records remain available if the relationship ends. Selling FOB while the distributor manages US imports and sales can be a sound business. If you intend to build your own US distribution network, access to data, marketing documents and arrangements for changing partners cannot remain entirely in the distributor’s hands.

Even when the device meets its marketing and quality requirements, entry data can still hold up the shipment. Somebody needs to check, before the vessel sails, that the numbers on the entry match the numbers on the registration, that the packing list matches the invoice, that the lot and expiry data exist in a form anyone could retrieve, and that the person named as importer was actually entitled to be there.

That check belongs in the normal shipment process. Not doing it costs demurrage, detention, a delayed launch, an irritated distributor, and sometimes a public refusal record that follows the firm name for years.

Team Global Logistics is a 4PL logistics company established in 1998, with branches across China's coastal ports and Southeast Asia. We work with medical device and disposables companies on consolidation across Asian countries, bonded warehousing, lot and expiry inventory control, warehouse compliance reporting, and predeparture verification of import documentation. This article is general information on regulatory and customs structures and is not legal or regulatory advice; confirm current requirements, fees and tariff rates for your specific products before acting.

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