Shipping Tracking Devices for Use In Clinical Trials in Japan: Everything You Need to Know
Digital tracking devices play a pivotal role in modern clinical trials. They enable remote monitoring, enhance patient safety, and support continuous, real-time data capture.
However, navigating Japan’s regulatory requirements for importing these devices can be complex and device-specific. Japan welcomes these advanced technologies, which are reshaping the design and execution of clinical trials. Therefore, it is essential for sponsors to understand the regulatory nuances that accompany this revolution.
Tracking devices in clinical research today are transforming how researchers conduct clinical trials. Right from enabling remote monitoring, boosting patient safety measures, and seamlessly capturing data continuously, their benefits are countless.
In a highly regulated clinical trial environment like Japan under PMDA, maintaining compliance while shipping tracking devices can be challenging. Sponsors must carefully plan, anticipate regulatory requirements, and coordinate early with PMDA guidelines. This ensures that tracking devices reach study participants on time and under the required conditions.
This article explains how clinical trials are evolving in Japan. It also describes the different types of tracking devices used, the prerequisites for shipping them, and the planning required to navigate this process successfully.
Evolving landscape of Clinical trials in Japan: The rising role of tracking devices
Similar to the global trend of adopting tracking devices in clinical trials, Japan has evolved to keep pace. In recent years, technology has transformed how researchers conduct clinical trials, especially in technologically advanced nations like Japan.
Innovative approaches, such as digital technologies and remote monitoring, help researchers address challenges in conventional trials. These challenges include patient recruitment difficulties and maintaining compliance throughout lengthy study periods. In Japan, where authorities and sponsors emphasize technological innovation, these devices help researchers collect precise data. They also reduce the need for participants to make frequent physical visits to study sites.
In a case study of diabetes clinical research in Japan by Fukushima N et al., wearable Continuous Glucose Monitoring (CGM) devices were used to track blood glucose levels continuously. The study showed multiple benefits. These included painless, affordable, discreet, accurate, and real-time glucose readings, with quick scans.
In another example of a trial with a three‑lead wearable electrocardiogram (ECG) monitoring device, the results provided more accurate data than traditional methods. With the continuous advancement of tracking devices, the future of clinical trials in Japan looks promising. Given the promising future of trackers in Japan, sponsors have an opportunity to use these essential tools to streamline study workflows, reduce site burden, and shorten timelines through real-time, continuous data capture.
Building on this progress, the next section speaks about the diverse range of tracking devices from wearables to sensors that are driving this evolution.
The types of tracking devices used in clinical trials
- Researchers now use a growing number of innovative tracking devices in clinical trials. These devices help collect data and ensure patient adherence remotely, 24/7.
- Common examples include smart-cap medication bottles, wearable smartwatches, temperature monitors, ECG monitors, blood pressure monitors, glucometers, and pulse oximeters.
- These novel devices not only collect objective data but also improve adherence monitoring. They enable early detection of protocol deviations.
- By collecting data remotely in real time, researchers reduce their reliance on self-reported information and frequent site visits. This improves both data accuracy and overall trial efficiency.
- Although PMDA regulations often impose strict requirements on shipping these devices into Japan, their operational and data-quality benefits are significant. Navigating this regulatory framework allows researchers to conduct clinical trials more efficiently and reliably.
An overview of the different types of tracking devices used in clinical trials is outlined below:
Overview of tracking devices
| Category | Device-Type | What It Tracks | Examples |
|---|---|---|---|
| Wearable Sensors | • Wrist worn • Smartwatches • Cuffs • Skin patch-based sensors • Finger worn • Connected medical devices • Remote monitoring kits | Device use patterns, inhaler actuations, treatment delivery, and device function | ECG patches, Holter monitors, accelerometers, sleep trackers, actigraphy devices, Digital BP monitors, pulse oximeters, glucometers, thermometers, spirometers, Continuous Glucose Monitoring systems (CGM) |
| Medication Adherence Tracking Devices | • Smart medication packaging • Electronic pill bottles • Smart blister packs • Ingestible sensors • Connected injector pens | Dose timing, pill access, injection administration, and ingestion verification | Medication Event Monitoring System (MEMS) smart caps, smart-pill bottles, Proteus ingestible sensors, smart insulin pens |
| Medical Device Performance & Usage Trackers | • Smart inhalers • Connected nebulizers • Smart infusion pumps • Implantable device trackers | Device use patterns, inhaler actuations, treatment delivery, device function | Bluetooth-enabled inhalers, smart nebulizers, connected drug-delivery systems |
For more information on the key trackers used in clinical trial operations and their benefits, please refer to our article on: Trackers in Clinical Trials
Now, having explored the different types of tracking devices, let’s move on to see how tracking devices work in clinical trials.
How do tracking devices work in clinical trials?
A majority of tracking devices used in clinical trials are wearable biosensors. These devices collect physiological data such as heart rate, blood pressure, movement, or activity. Wearables often include microprocessors, sensors, and smartphone interfaces. They use wireless communications to document real-time data and exchange information with other devices or centralised databases.
Multiple wearable sensors can collect data and transmit it to a body area network (BAN). This network connects the devices to a central hub, such as a smartphone or dedicated gateway. The BAN then sends medical data from wearable devices to the Internet or study servers. It uses wireless communication methods such as Bluetooth, radiofrequency, Wi-Fi, or cellular networks (LTE, 3G, 4G, or 5G). The choice depends on the device design, battery capacity, and the need for direct Internet connectivity.
In another instance, sensors send data to wearable devices or patches. These devices then transmit the data to a local gateway, such as a smartphone or dedicated hub. The devices encrypt and send the data to the cloud or central server. Researchers then integrate the information into the clinical trial’s data infrastructure, such as an Electronic Data Capture (EDC) platform.
Since this information often contains sensitive data, maintaining security and encryption during transmission and storage is essential. Once the data is stored in the cloud or central server, it can be accessed by the sponsor or trial management team for monitoring, analysis, or real-time safety oversight. There is also a possibility of linking these data flows directly with electronic case report forms and EDC systems.
Regulatory Considerations for Wearables in Japan
When importing wearables or sensor devices for clinical trials in Japan, regulatory compliance is essential. Sponsors must consider device classification under the Pharmaceuticals and Medical Devices Act (PMD Act). They also need to address data privacy requirements, labeling, and documentation standards. Additionally, it is important to ensure that the devices function reliably under local network and power conditions.
The following section outlines the key regulatory marking requirements for medical devices in Japan, including trackers used in clinical trials.
Regulatory marking requirements for trackers in Japan
The regulatory marking requirements in Japan for trackers used in clinical trials are summarised below for quick reference.
| Mark/ Requirement | Description |
|---|---|
| Giteki Mark (Technical Standards Conformity Certification) | A government approval mark mandatory for using wireless devices in Japan without affecting other communications. Always accompanied by an R or T classification and certification number. |
| R-Mark (Radio Equipment) | The radio-equipment category identifier that appears next to the Giteki symbol. Indicates the device is certified as radio-transmitting equipment under the Giteki system |
| T-Mark (Telecommunications Terminal Equipment) | The telecommunications- terminal category identifier within the Giteki system. |
| HFD Mark (High-Frequency Device) | A mark indicating a device emits high-frequency energy but does not perform radio communication. |
| PSE Mark (Electrical Appliance & Materials Safety) | Japan-specific electrical safety mark confirming that a product meets electrical safety standards. |
Collectively, understanding and ensuring these markings are applied early helps to import devices like trackers smoothly into Japan, thus accelerating the overall process. Now, let us move on to the planning aspect of importing trackers into Japan for clinical trials.
Navigating the import of trackers for Clinical trials in Japan
There are two pathways for importing trackers required for conducting clinical trials into Japan:
- One is the standard regulatory pathway for commercial distribution of such devices, which involves formal registration and approval. Once these devices are registered, they can be used in the clinical trials
- The other process includes permitting the importation of medical devices without full product registration, supporting investigational use, or for clinical trial purposes.
While the conventional route for commercial registration is essential for long-term market use, this pathway is usually opted for broader and repeated use of devices across multiple clinical trials or for commercial distribution. As a result, the approval process takes six months to two years, depending on the class it falls under. Such timelines are not always practical in the case of clinical trial schedules, where prompt availability of supplies is critical. In such situations, an alternative pathway with specific provisions defined by PMDA allows the importation of digital trackers solely for clinical trial use. These provisions differ significantly from those applied to commercially marketed devices and vary according to device functionality, data communication methods, and classification.
Given the diversity of tracker technologies and their regulatory implications, a device-specific assessment is essential to determine the applicable requirements for trial use. In order to determine the appropriate regulatory route and the nuances of these pathways, a tailored evaluation is undoubtedly essential to ensure compliance.
Conclusion
As we have seen, trackers have become increasingly important in clinical trials, given their critical role in collecting real-time data and supporting patient monitoring. These devices in Japan are subject to specific regulated marking requirements, which must be considered even when importing devices for trial purposes.
Sponsors and organisations planning to ship clinical trial trackers into Japan should also conduct a thorough review of the regulatory options specific to their devices. A detailed, device-specific assessment can help identify the most efficient and compliant pathway, ensuring timely trial execution while maintaining adherence to PMDA requirements.
Are you planning to use trackers in your clinical trials and are not sure about Japan’s import or regulatory requirements?
Discuss your tracker details with our team to understand the specific requirements for importing your device into Japan for clinical trials or commercial use. Fill in the details in the form to connect with the appropriate team.