Guide to shipping medical equipment to USA

Japan’s reputation for producing high-precision, world-class medical devices is globally recognized.¹ From advanced diagnostic equipment to meticulously manufactured surgical instruments, the demand for Japanese medical technology in the US healthcare market has never been higher. 

The scale of this opportunity is staggering. Data from 2024 reveals that Japan exported medical instruments worth ¥877 billion, making it the nation's 19th most valuable export category. The primary destination for this remarkable output was the United States, which accounted for ¥289 billion of those shipments. The US was also the fastest-growing market for these exports between 2023 and 2024, with an increase of ¥52.6 billion.²

This presents a significant opportunity for Japanese manufacturers and distributors. However, bridging the Pacific is a complex process where regulatory compliance, product sterility, and safety are crucial. Mistakes in this domain can lead to costly delays, customs seizures, and, most critically, a compromise in patient care.

Understanding the regulatory landscape: USFDA and PMDA compliance

Shipping medical equipment overseas, especially specialized devices classified as surgical instruments, requires compliance with strict international regulations designed to protect patients and uphold healthcare standards. In Japan and the US, two key regulatory bodies oversee these processes: the PMDA (Pharmaceuticals and Medical Devices Agency) and the USFDA (The Food and Drug Administration, Department of Health and Human Services, Government of the United States of America).³

The role of Japan's PMDA (Pharmaceuticals and Medical Devices Agency)

Before a medical device can be considered for export, it must be fully compliant with Japan's domestic regulations. The PMDA is responsible for ensuring the quality, efficacy, and safety of all pharmaceuticals and medical devices manufactured and marketed in Japan.⁴ This means that any device you intend to ship must have already met the stringent standards for approval within the Japanese market. This domestic compliance is the foundation upon which your export strategy is built.

The role of the US FDA (Food and Drug Administration)

Once your medical device shipment arrives in the United States, it is subject to oversight by the US Food and Drug Administration (FDA)—the federal authority responsible for regulating the importation of all medical devices to ensure their safety, effectiveness, and compliance with public health standards.⁵

FDA regulation is comprehensive and non-negotiable. Devices must undergo classification, premarket review (if applicable), and meet stringent quality system requirements. For your shipment to be cleared without delay, the following key elements must be in place:

• Establishment registration: All foreign manufacturers must register their production facility with the FDA. This registration is mandatory and must be renewed annually.
• Device listing: Each specific device intended for export—such as surgical instruments—must be properly listed in the FDA’s medical device database.
• US agent: Foreign manufacturers are required to appoint a US-based agent. This individual or entity serves as the official point of contact between the FDA and the manufacturer for all regulatory matters.

It is crucial to understand that the importer, the product, and the manufacturer must all be fully compliant with these FDA regulations for medical devices. Any discrepancy can result in an immediate hold on your shipment at the port of entry.

Essential documentation: Your passport through customs

When importing or exporting medical equipment overseas, documentation is essential for customs clearance. Incomplete or inaccurate paperwork is the leading cause of customs delays, shipment holds, or rejections by US authorities. For shipments involving surgical instruments or any regulated medical device, all documents must be precise, complete, and fully compliant with FDA and US customs requirements.

Commercial invoice

A commercial invoice is an important document in international trade, serving as the official bill between the exporter and importer. It provides customs authorities with essential information to assess duties, taxes, and ensure regulatory compliance. For medical device shipments, the commercial invoice must be detailed and accurate to prevent delays or clearance issues.

Required details for medical device invoices include: 

• Full name and address of the manufacturer, shipper, and the US consignee (importer).
• A precise description of each device. For surgical instruments export, for example, do not just write "surgical tools." Instead, specify: "Sterile Stainless Steel Scalpel, Model #XYZ."
• The correct Harmonized System (HS) Code for each specific device.
• The Country of Origin (COO)
• The accurate valuation of the goods for customs purposes.

Including all these details helps customs authorities quickly verify the shipment’s contents and ensures smooth processing across borders.

FDA prior notice and registration numbers

For all medical devices entering the US, the Food and Drug Administration (FDA) requires Prior Notice (PN) before the shipment arrives. This alert allows the FDA to assess incoming products and allocate resources for inspection or release as needed.

Critical information that must be submitted and reflected in the shipping documents includes:

• FDA establishment registration Number of the Japanese manufacturer.
• Device listing number corresponding to each product being shipped.
• US-based importer’s registration number.
• Name and contact details of the designated US Agent (if required).

Failure to include these registration numbers may trigger automatic detention at the US port of entry.

Air Waybill (AWB)

An Air Waybill is a non-negotiable document issued by the air carrier or logistics provider. It serves as a receipt of goods, a contract of carriage, and a tracking reference throughout the shipment’s transit. For medical device exports, the AWB ensures traceability and communicates handling instructions such as "Fragile," "Sterile," or temperature control requirements. It typically includes:

• Shipper and consignee details
• Flight routing information
• Shipment weight and dimensions
• Unique AWB number for tracking

Although not used to assess customs duties, the AWB is essential for transportation and coordination between shippers, carriers, and customs authorities.

Certificate of Origin (if applicable)

A Certificate of Origin (COO) is sometimes required, particularly if claiming preferential tariff treatment under a free trade agreement or to confirm the product's origin for regulatory purposes. While not always mandatory for medical devices, it may be requested by:

• US Customs to validate the product’s manufacturing origin
• Importers who require it for internal documentation or tariff exemption

When included, this certificate must clearly state the country where the medical device was manufactured and be signed by an authorised body (e.g. Chamber of Commerce)

Packing list

While not required by the FDA, a packing list helps customs officers quickly identify the contents of the shipment and cross-check against the invoice.

It should include:

• A breakdown of the products by item, quantity, and packaging
• Box numbers or pallet references
• Net and gross weight per package

For consolidated shipments or multiple SKUs, this document is especially useful during inspection.

Proof of sterilization of medical devices

For medical devices or surgical instruments shipped in a sterile state, providing accurate sterilization documentation is a critical regulatory requirement. Manufacturers must validate their sterilization processes and maintain detailed records demonstrating compliance with sterility standards.

In the United States, devices labeled as sterile typically include this information as part of a 510(k) premarket notification submission to the FDA. This documentation proves that the sterilization method used is both effective and consistent with FDA-approved protocols.

To ensure smooth customs clearance, manufacturers should have the following information ready at shipment:

• The sterilization method used (e.g., ethylene oxide, gamma irradiation, steam sterilization).
• A confirmation that the product is sterile and safe for handling and clinical use.
• Supporting documentation issued by an accredited laboratory or an authorized internal quality assurance process.

This documentation is closely reviewed by both the FDA and US Customs and Border Protection (CBP). Missing or incomplete records may result in shipment holds, inspection delays, or rejection at the port of entry.

Packaging for sterility and safety: A step-by-step guide

When packing a shipment for international shipping, especially medical devices, maintaining both physical protection and sterility is critical. The journey exposes devices to risks such as impacts, pressure changes, and temperature fluctuations — making proper packaging a non-negotiable part of compliant medical equipment delivery. Each packaging layer plays a vital role in safeguarding product integrity from origin to destination.

Primary packaging (The sterile barrier)

The primary packaging is the first layer and comes into direct contact with the medical device. It typically consists of a sealed, medical-grade pouch or rigid tray designed to maintain a sterile environment. This sterile barrier system must be validated, and its integrity must remain intact upon arrival. Any breach in this layer compromises sterility and may result in rejection or reprocessing.

Secondary packaging (The protective layer)

The package is then enclosed within a rigid, protective container, which shields it from external forces that could compromise the barrier. This protective layer is designed to withstand punctures, compression, and impacts during handling. To prevent internal movement, custom foam inserts or molded trays are often used to stabilize the instrument within the box, reducing the risk of transit-related damage.

Tertiary packaging (The shipping box)

The final layer is the outer shipping carton—a new, high-strength corrugated box built to endure international shipping conditions. This carton must be clearly labeled with all required markings, including “Sterile,” “Medical Device,” or biohazard symbols where applicable. Labels should also include handling instructions and accurate shipping details to support smooth customs inspection and regulatory compliance.

Why trust DHL Express for your medical shipments?

Shipping medical devices across borders demands more than speed—it requires deep regulatory insight, airtight logistics coordination, and unwavering reliability. DHL Express delivers on all fronts, making it the trusted partner for Japan’s medical device exporters.

• Regulatory expertise: DHL's dedicated team of in-house customs experts is profoundly well-versed in global medical device regulation, including FDA requirements. DHL helps ensure documentation is compliant before the shipment even leaves Japan, preventing issues before they arise.
• Network security: Built on an understanding of the need to protect high-value, sensitive goods, the DHL network is secure, monitored, and controlled from end to end, providing a secure chain of custody for critical assets.
• Specialized services: For devices that require it, DHL offers specialized value-added services, including temperature-controlled shipping and proactive tracking and intervention to ensure the integrity of the shipment.
• Global compliance: With established procedures for handling medical devices worldwide, DHL provides the peace of mind that comes from partnering with a globally compliant and experienced leader. This expertise extends to heavy equipment transportation for larger diagnostic machines, ensuring consistent quality across all shipping needs.

Delivering precision and peace of mind

Successfully shipping medical devices from Japan to the US rests on the three key pillars: regulatory compliance, meticulous documentation, and protective packaging. In such a highly regulated and time-sensitive industry, partnering with an experienced logistics provider is essential.

DHL Express Medical Express (WMX) is a specialized solution tailored for the Life Sciences and Healthcare sector, addressing the unique requirements of time-and-temperature-sensitive shipments. With industry-specific handling, end-to-end visibility, and deep regulatory expertise, DHL Express ensures the medical devices arrive safely, compliantly, and on schedule.

Learn more about DHL's dedicated healthcare logistics solutions and open a business account with DHL Express Japan today to ensure your medical devices are in the safest hands.