By Nick Lung    Photo：CANVA

I. Definitions and Regulatory Basis

In the United States, for the importation of medical devices (and certain radiated electronic products), the role of the initial importer is clearly defined by regulations. According to the Food and Drug Administration (FDA) website:

“An initial importer is defined … as any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale of the device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package.”

The regulatory source is 21 CFR § 807.3(g) (i.e., Section 3(g) of Part 807 of the Federal Regulations).

Let's examine this more closely:

"Further the marketing" means that after the device is produced by a foreign manufacturer, it is then pushed forward or delivered to the next sales/distribution party in the United States, ultimately reaching the consumer or user.

However, the initial importer must not "repackage/alter the container, packaging, or labeling" the device. This is a crucial condition for distinguishing between an initial importer and a repackager/alterer.

The initial importer must have a physical address in the United States and responsible personnel to ensure that the goods comply with FDA regulations.

Furthermore, the initial importer must register, pay annual fees, and maintain its established records. Therefore, from a regulatory perspective, the initial importer is a specific, regulated role, not merely a transportation agent or a simple customs broker; it involves compliance monitoring responsibilities.

II. Key Responsibilities and Obligations

Since the initial importer is legally defined, what it does and what it is responsible for is crucial. Based on multiple sources, I have summarized the main responsibilities as follows:

1. Registration and Establishment

The initial importer must register its establishment with the FDA and, in some cases, list its devices.

A physical address in the United States (not just an email address) and verifiable facilities or personnel are required.

2. Compliance Monitoring of Imported Goods

Ensure that devices imported from foreign manufacturers comply with FDA requirements before, during, and after importation, such as: appropriate labeling, manufacturer registration, and completion of necessary pre-market filings (e.g., 510(k)/PMA) or exceptions.

At import customs clearance, the information submitted regarding the "manufacturer," "importer," and "description of goods" must be consistent with the FDA registration system; inconsistencies may result in the goods being detained.

3. Monitoring and Reporting Obligations

The initial importer is responsible for "Medical Device Reporting (MDR)." This means that any device that may or could cause death, serious injury, or malfunction must be reported to the FDA.

It also includes obligations regarding "Corrections & Removals" and "Tracking," if the device falls into a category requiring tracking.

4. Serving as the FDA's Contact Point

The initial importer in the United States is the FDA's "contact point" with the device/manufacturer. When the manufacturer is overseas, the FDA needs a traceable, inspectable, and accountable agency in the United States. The initial importer plays this role.

Therefore, in practice, if a medical device is exported from an overseas manufacturer to the United States without fulfilling the responsibilities of the initial importer as described above, it may be detained by customs/FDA, refused entry, or even recalled.

III. Comparison/Boundaries with Other Import Roles

To avoid confusion, it's crucial to understand the differences between the Initial Importer (II) and the following commonly mentioned roles when exporting to the United States:

1. Initial Importer: As mentioned above, this refers specifically to the import bridge from the foreign manufacturer to the U.S. seller, without repackaging/relabeling. The focus is on compliance.

2. Importer of Record (IOR): This is a customs-level role responsible for declaring goods to U.S. Customs and Border Protection (CBP), paying customs duties/taxes, and providing customs information. Its responsibilities are more related to customs duties and import declarations than FDA regulations.

3. Re-packager/Relabeler: If a U.S. entity alters the packaging, labeling, or repackages the product, then that entity is not purely an initial importer but may be considered a manufacturer, relabeler, or repackager, with different responsibilities and regulatory requirements.

From a practical standpoint: If you are exporting medical devices from Taiwan or other countries to the United States, you need to confirm the legal role of "Initial Importer," not just "who handles customs declaration." Often, manufacturers or overseas exporters mistakenly believe they are the "importer"—but this can lead to problems if they don't have an entity in the U.S. or fulfill the obligations of an Initial Importer.

IV. Some Advice for Those Planning to Develop the U.S. Medical Device Market

When you are a manufacturer located overseas (e.g., in Taiwan) planning to export medical devices or similar strictly regulated products to the United States, understanding and cooperating with the Initial Importer's role in the U.S. market process becomes crucial. You can start with the following points to ensure your goods clear customs smoothly, enter the market, and maintain compliance:

1. Verify the Partner's Identity and Responsibilities Beforehand: When selecting or arranging an Initial Importer in the U.S., you should confirm that the entity is registered with the Food and Drug Administration (FDA), has a U.S. physical address, and can fulfill regulatory responsibilities, including reporting adverse events and maintaining tracking systems.

2. Process Data and Document Integration: You need to provide the initial importer with complete and accurate manufacturer information, product descriptions, labeling/packaging information, and compliance documentation (e.g., whether a 510(k) or PMA has been submitted). If the "declarant name/address/product description" used by the initial importer during customs clearance is inconsistent with the information in the FDA system, the goods may be delayed or rejected.

3. Clear Liability Definition and Cooperation Process: You should clearly define with the initial importer which steps are your (the manufacturer's) responsibility and which are theirs (the initial importer's). For example, whether the product packaging has been modified, whether the label has been changed, and who handles the after-sales feedback mechanism. Remember, if the initial importer repackages or relabels the product, they may no longer be a "simple initial importer," and their regulatory obligations will change.

4. Risk Preparedness and Customer Support: You should include the initial importer's ability to respond quickly to adverse events/recalls in your evaluation criteria and allocate time and resources during the transportation/customs clearance process. Once goods enter the U.S. market, the subsequent oversight obligations (such as reporting adverse events and tracking) borne by the initial importer will be reflected in your brand's reputation and contract fulfillment. A well-cooperative initial importer can serve as a reliable bridge in the U.S. market, helping to reduce the risk of shipments being detained or violating regulations.

Appreciate if you could share TGL Blog among your friends who are interested in first-hand market information of supply chain and updated economic incidents.