Background and Legal Framework

Japan’s Unique Device Identification (UDI) system was formally established under the 2019 amendment to the Pharmaceutical and Medical Devices Act (PMD Act). The act was amended in 2019 as part of a major reform effort by the Japanese government. The purpose of this new system is to improve traceability, enhance access to safety information, and assist with the digitalization of health care.

The UDI program was implemented on December 1, 2022. Under this program, manufacturers are required to include bar code labels on their products’ packaging and enter their UDI information into KikiDB (the official database for UDI in Japan). This should be done at the time of final product release by the Marketing Authorization Holder (MAH). Manufacturers were allowed to sell devices that were released prior to December 1, 2022, without having to comply with UDI requirements. However, most manufacturers have replaced the majority of their legacy stock with UDI-compliant devices by 2025.

Labeling and Database Registration

The Japanese UDI framework includes two main components: physical labeling and database registration. Medical devices must have a compliant barcode on the container, and the corresponding device information must be registered in KikiDB.

Key data points required for registration include Global Trade Item Numbers (GTINs), product names, model numbers, and classification details. Because registration is performed by the MAH or Designated MAH (DMAH), overseas manufacturers must ensure timely and accurate data sharing. Errors or delays in registration can disrupt product distribution, reimbursement processing, and access to updated device information.

UDI and the Shift to Electronic Labeling

UDI is closely integrated with Japan’s electronic labeling system. In August 2021, paper package inserts for medical devices were abolished in principle. Instead, healthcare professionals now access electronic instructions for use (e-IFU) by scanning the product barcode with a smartphone or tablet.

The UDI serves as the digital access key to the latest safety and usage information. If a device is not properly labeled or registered in KikiDB, medical staff may not be able to retrieve up-to-date product details.

Japan applies UDI requirements broadly across nearly all device classifications. Class I (general) medical devices are subject to mandatory labeling and registration, as are Class II, III, and IV devices. This comprehensive approach differs from some jurisdictions that phase implementation by risk class.

Only limited UDI exceptions exist, such as certain home-use products or extremely small devices where physical labeling is impractical. Overall, Japan’s framework reflects a system-wide commitment to traceability and data integration.

Integration with Insurance Reimbursement Systems

UDI data is directly linked to Japan’s national insurance billing infrastructure. For products categorized as “Specially Designated Treatment Materials,” accurate UDI registration is essential for claims processing.

If registration is incomplete or incorrect, hospitals may experience delays or even failures in reimbursement. This creates a direct commercial impact – products that are not properly registered risk reduced marketability. As the linkage between UDI and reimbursement codes strengthens, compliance has become a critical factor in ensuring smooth product adoption by healthcare institutions.

UDI Within Japan’s Medical DX Strategy

The significance of UDI must be understood within the broader context of Japan’s Medical DX (Digital Transformation) policy. Beginning in 2025, hospitals started actively using national digital platforms to share medical data, signaling a new phase in Japan’s healthcare modernization.

One pillar of Medical DX is the National Healthcare Information Platform, which enables real-time sharing of patient data across medical and nursing facilities. Thus, the My Number Card now functions as the primary identification key and replaces traditional health insurance cards.

Another initiative focuses on the standardization of electronic medical records (EMR). Historically, EMR formats varied by healthcare institution. Starting in fiscal year 2026, the government plans to introduce a low-cost standardized EMR system to help smaller clinics connect to the national network.

In parallel, Medical Fee Revision DX aims to streamline Japan’s reimbursement revisions by introducing common calculation software to reduce administrative burden. Within this expanding digital ecosystem, UDI functions as a foundational identifier linking device information, electronic labeling, reimbursement systems, and national healthcare databases.

Key Considerations for Foreign Manufacturers

For overseas manufacturers, close coordination with a Japanese MAH or DMAH is essential. While it is the MAH’s or DMAH’s responsibility to register the products in the KikiDB database, it is ultimately the device manufacturer’s responsibility to provide accurate and complete information to the MAH/DMAH. Therefore, manufacturers should plan for GTIN allocation, product classification alignment, and labeling design early to avoid any compliance gaps later in the process. Additionally, as Japan’s healthcare system continues toward digitalization/medical DX, UDI compliance should be seen as part of a larger digital regulatory strategy, rather than a one-time requirement for labeling. Manufacturers who proactively align with Japan’s Medical DX will be best positioned for long-term success within Japan’s marketplace.

Conclusion

Japan’s UDI system has transitioned from regulatory introduction to full operational integration. Since mandatory enforcement began in December 2022, the market has largely converted to compliant products. For foreign medical device manufacturers seeking sustainable access to the Japanese market, maintaining strict UDI compliance is now fundamental to both regulatory and commercial strategy.