Japan Medical Device Software
The Government of Japan (GOJ) is actively undertaking measures to enhance the regulatory review process for medical devices, particularly stand-alone software used for medical purposes, also known as Software as a Medical Device (SaMD). Examples of SaMD include glucose monitoring apps, medication reminder apps, and telemedicine platforms that enable remote consultations between patients and healthcare providers. Japan still trails behind other nations in this digital health sector. For instance, as of September 2023, Japan had only approved three therapeutic apps, whereas the U.S. and Europe had approved more than fifty therapeutic apps.
Acknowledging this disparity, the Ministry of Health, Labour and Welfare (MHLW) has been implementing various initiatives to expedite the commercialization of SaMD products. In September 2023, MHLW unveiled its second SaMD strategy, “Digital Transformation Action Strategies (DASH) for SaMD 2,” building upon the former framework, “DASH for SaMD,” that was established in 2020. The primary objective of “DASH for SaMD 2” is to streamline the path to commercialization and ensure predictability. This includes the introduction of a two-stage approval system where initial approval may be granted for a limited scope of intended uses based on how well the software performs in tests, even if the ultimate clinical significance has not yet been fully established. Subsequently, second-stage approval can be obtained after more evidence and data is gathered from real-world use. The implementation of this two-stage approval system is expected to commence in 2024, making the approval process more flexible and responsive to real-life outcomes.
Furthermore, in January 2024, Japan’s Pharmaceutical and Medical Device Agency (PMDA) released its draft fifth mid-term plan, covering the period from JFY 2024 to JFY 2028. Within this plan, PMDA has introduced a target review timeframe of six months for SaMD products undergoing priority review. Additionally, PMDA intends to restructure its organization to incorporate a department dedicated to SaMD review and establish a new consultation category for improved guidance and support.
While these initiatives are aimed at supporting and promoting Japanese companies, it is noteworthy that U.S. firms with advanced SaMD products also stand to benefit. This includes a variety of companies that offer innovative products, such as x-ray imaging software, patient data collection software, and applications for medicine dosage analysis and calculation. These companies should stay attentive to emerging trends and access opportunities in the Japanese market. For more information, please contact the U.S. Commercial Service at Office.Tokyo@trade.gov.