Japan has one of the most tightly regulated pharmaceutical landscapes, which necessitates a seamless supply of laboratory kits (for clinical trials) to its sites. The process requires strict adherence to the guidelines of the Pharmaceuticals and Medical Devices Agency (PMDA). For sponsors and CROs, this raises the question of how to supply laboratory kits to clinical trial sites in Japan. Any non-compliance with the PMDA regulatory guidelines can halt trials, incur fines, or cause customs delays.

The laboratory kits must align with the PMD Act, GCP, and Good Distribution Practice (GDP). This article outlines essential requirements that sponsors and CROs need to follow to supply laboratory kits to clinical trial sites in Japan: 

• Accurate classification to identify import restrictions
• Timely PMDA submissions via Clinical Trial Notification (CTN)
• Compliant shipping and labeling
• Efficient in-country distribution

But first, let us understand how kits are defined in clinical trials. 

What are laboratory kits for clinical trials?

Laboratory kits encompass a range of non-drug materials used in clinical trials to support biomarker analysis, safety monitoring, and efficacy assessments. These include collection tubes, reagents, collection swabs, diagnostic materials, and storage containers for biological samples like blood or tissue. Unlike IMPs, lab kits are ancillary supplies that enable protocol-mandated testing but do not directly treat participants. In Japan, they must be evaluated under PMDA’s framework to ensure they do not qualify as medical devices (e.g., in vitro diagnostic kits) or hazardous goods.

Examples of clinical trial laboratory kits

Type of Kit	Purpose	Common Components Included
Blood Collection Kit	Collect and process blood samples for analysis (safety labs, biomarkers)	Vacutainer tubes (EDTA/serum/heparin), tourniquet, alcohol swabs, needles, biohazard bags, labels, centrifuge instructions
Urine Sample Collection Kit	Measure renal function, biomarkers, and hormone levels	Sterile urine cup, preservative vial, transfer pipette, labels, collection instructions, transport container
Saliva Collection Kit	DNA/RNA extraction, cortisol levels, infectious disease detection	Saliva swab or funnel tube, stabilizing buffer, barcode labels, user instructions, transport pouch
Stool Sample Kit	Microbiome studies, GI infection testing, pharmacokinetics	Stool collection device, sample spoon, container with preservative, gloves, absorbent sheet, cold chain packaging
Swab Collection Kit (Nasal/Throat)	Respiratory pathogens (e.g., influenza, COVID), viral load studies	Flocked swabs, viral transport medium (VTM), tube labels, sterile packaging, and sample handling instructions

Why compliance matters for the import of laboratory kits to Japan

Compliance with PMDA regulations is a prerequisite for uninterrupted trial timelines and participant safety. Japan’s import controls, governed by the PMD Act and Food Sanitation Law, scrutinize kits for biohazards, flammables, or controlled substances. Any misclassification can lead to customs holds (up to 14 days), shipment rejections, or trial delays costing a lot of money. 

To note, non-compliance risks include regulatory audits, GCP violations, or exclusion from PMDA’s strict mandates. Also, kits must align with GCP for ethical conduct and GDP. It is often required to reference the study protocol for usage guidelines to safeguard data quality and patient well-being. 

Now we turn to the practical implementation steps, as each phase requires careful planning and coordination. Let’s look at the systematic approach detailed in the next section, presented as guidelines. Sponsors and CROs can follow these guidelines/steps for supplying laboratory  kits to clinical trial sites in Japan: 

Steps to supply laboratory kits to clinical trial sites in Japan 

Step 1: Classifying and preparing laboratory kits accurately

Kit classification

• Sponsors/CROs can begin by reviewing each kit component against PMDA’s classification criteria. It is essential to determine if items qualify as medical devices under the PMD Act. 
• As some kits may be classified as medical devices, they require different regulatory obligations, including compliance with device-specific standards. To perform these activities, consultation with regulatory experts is required for ambiguous cases. This initial assessment, hence, prevents costly reclassification later.
• Moreover, the rationale of classification needs to be documented thoroughly. And it is advisable to include manufacturer specifications and statements specifying the intended use. 

Labeling requirements

• Clinical trial materials shipped to Japan require carefully designed labels that communicate essential product information in both English and Japanese. 
• Labels must clearly identify the materials and also provide critical safety and handling information. 
• They must also include these items are intended exclusively for “clinical trial purposes”. 
• Proper packaging with appropriate temperature controls (for temperature-sensitive materials) also ensures materials arrive in optimal condition and move smoothly through customs clearance.

Step 2: Regulatory compliance and submissions

Preparing technical specifications

• Sponsors must prepare clear, detailed technical specifications that help PMDA determine whether the materials fall within the scope of the study and confirm that they pose no safety or regulatory concerns.  
• Successful regulatory submissions begin with comprehensive technical documentation that describes the trial materials in detail. 
• These specifications help Japanese regulatory authorities evaluate the safety and suitability of the materials for the proposed study. Credevo can assist you through the documentation requirements to ensure your submission meets PMDA expectations.

Unsure of which category your product falls under? If you have any questions or queries regarding laboratory kits, medical devices, ancillaries, or IMPs, please fill out the form below to connect with us.

Preparing and providing the necessary documents

Getting clinical trial materials into Japan requires accurate documentation and knowledge of local regulations, such as:

• All shipping documents must match actual materials exactly, and products may be classified differently in Japan than in other countries. Hence, working with experts who understand Japanese regulatory requirements can help avoid delays and start the trial faster.
• An experienced IOR/EOR can navigate customs requirements and ensure your submissions align with PMDA filings. 

Step 3: Logistics and shipping to Japan

Appointment of Importer of Record (IOR)

• Japanese regulations require the appointment of a local entity as an Importer of Record. This IOR must be based in Japan. 
• Hence, the IOR becomes the legal importer of the kits. They handle all customs declarations, pay any applicable duties, and manage the technical aspects of importation. An IOR also coordinates directly with PMDA on behalf of the stakeholders.

Shipping methods

• Usually, validated freight forwarders experienced in pharmaceutical logistics are engaged for shipping. Air freight is preferable for temperature-sensitive or urgent shipments.

Customs clearance

• The Importer of Record (IOR) handles all customs paperwork before the shipment arrives. They prepare the necessary documents and assign HS codes to each item. HS codes are international product classification numbers.
• Clinical trial kits often qualify for duty-free import under special CTN provisions. But the appointed IOR will confirm if kits are eligible. This can save money and speed up the process.
• Good customs management always prevents shipments from delays, which can otherwise disrupt trial timelines and waste money.

Step 4: In-country distribution and site delivery

• Sponsors and CROs must choose between two primary distribution models based on trial size, timeline, and logistical complexity. They can choose either a direct-to-site distribution or a central-depot model. However, while they can choose any of these models, choosing the right distribution partner is fundamental for in-country logistics. 
• For site delivery coordination, a pre-delivery site preparation is often useful for easy delivery or shipment. Before shipments arrive, sites should receive detailed advance shipping notices containing kit descriptions, quantities, storage requirements, and expected delivery dates. Site staff must verify that appropriate storage space is available and that environmental conditions meet protocol specifications. 

Best Practices for Sponsors and CROs

• Starting early with IOR: Sponsors can begin working with IOR as soon as they start planning their study. An experienced IOR can help them understand what’s required and prevent problems before they happen.
• Choosing partners who know Japan’s regulatory framework: By working with IORs and vendors that have real experience with PMDA regulations and Japanese clinical trials, CROs and sponsors can streamline their shipment from the start. 
• Keeping documents organized: Creating files that are ready for inspections at any time can help avoid customs delays or rejections. It is necessary to make sure that all PMDA applications, labels, inventory records, and study protocols match and reference each other. It is advisable to use digital signatures when approving documents, as this makes it easier to track who approved what and when.
• Using eco-friendly packaging materials: Sponsors/CROs can consider eco-friendly packaging materials, which reduce transportation emissions, and recyclable temperature control solutions. Aligning distribution practices with Japan’s environmental policies demonstrates responsibility and may facilitate regulatory interactions. 

Conclusion

Supplying laboratory kits to clinical trial sites in Japan requires careful planning and attention to detail. While the process may seem complex, breaking it down into clear steps makes it manageable. Early planning prevents expensive delays, keeps the trial on schedule, and protects participant safety. Choosing partners who have real experience with PMDA and Japanese clinical trials serves as an advantage for sponsors/CROs. Therefore, with good preparation and the right partners, supplying laboratory kits to Japan becomes a straightforward process that supports successful clinical trials.

Are you planning to supply laboratory kits to clinical trial sites in Japan? Or are you currently facing challenges with kit classification, PMDA submissions, or customs clearance?

Our experts can help you classify your kits, prepare compliant technical specifications and CTN documentation, and provide IOR services to ensure smooth customs clearance.

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