Japan Medical Device Registration: Digital Healthcare Update 2024

Japan Advances Regulatory and Reimbursement Frameworks for SaMD Products

After a slow start, Japan is now taking decisive action to modernize its regulatory and reimbursement systems for Software as a Medical Device (SaMD), aiming to match the rapid pace of global healthcare innovation. The Pharmaceuticals and Medical Devices Agency (PMDA) has introduced several initiatives designed to accelerate the review process and integrate these cutting-edge technologies into the Japanese healthcare landscape more efficiently.

Streamlining SaMD Approvals through Enhanced Review Protocols

A significant development from the PMDA came from its meeting on March 13, 2023, where it was resolved that SaMD products would undergo a priority review process completed within six months. This update stems from the success of the pilot program titled “Trial Implementation of Priority Review for Program Medical Devices,” which began in September 2022. For eligibility, SaMDs must be either first introduced in Japan or launched simultaneously in global markets and must demonstrate innovative approaches in treatment or diagnosis that are significantly more beneficial compared to existing solutions.

In a further enhancement of the regulatory process for SaMD products, the PMDA, considered a new two-stage approval mechanism during their May 29, 2023 session. This two-stage program allows for an initial approval based on demonstrated efficacy, followed by a more thorough assessment based on safety and efficacy data gathered from clinical usage and post-marketing studies. The guidance document outlines distinct registration criteria for diagnostic, therapeutic, and preventive SaMD products. For instance, therapeutic SaMDs must demonstrate their ability to alleviate patient symptoms through non-clinical studies or address medical conditions lacking existing treatments. This method seeks to address the urgent need for new medical technologies while ensuring comprehensive safety evaluations through ongoing surveillance.

Refining Reimbursement Strategies to Support SaMD Integration

Reimbursement considerations for SaMDs were prominently discussed in the Chuikyo meeting on July 26, 2023 focusing on the fiscal year 2024 reimbursement policy. The discussion emphasized the need to tailor reimbursement policies to the clinical value of SaMD products. Various models are under review, including adjustments to existing medical fees, the application of medical fee premiums, and a cost-based approach. The potential for modifying reimbursements based on the health benefits observed post-deployment was also considered. This highlights the importance of adapting to the real-world efficacy of these technologies.

Aligning with International Standards and Practices

In its efforts to synchronize with international regulatory and reimbursement practices, Chuikyo has further explored reimbursement rates applied in foreign markets. This international perspective is vital for setting competitive and equitable pricing for SaMDs in Japan, ensuring that the pricing structure reflects the innovative nature and clinical benefits of these types of products.

The PMDA announcement of the “Dash for SaMD2” program marked a further commitment to enhance regulatory capacities, which includes expanding the SaMD review team and establishing a subscription-based consultation service for SaMD products. In addition to increasing the size of its SaMD review team and providing additional consultation opportunities, the PMDA announced on January 22, 2024 as part of its five-year plan (2024-2028) that it aims to ensure all reviews of SaMD products for registration will now be finalized within a six-month timeframe.

Future Outlook

These proactive measures signify Japan’s commitment to fostering the rapid introduction and integration of SaMD technologies. By optimizing both approval processes and reimbursement models, Japan not only accelerates the delivery of advanced medical technologies to its healthcare system but also positions itself as a leader of the global digital health space.