Japan has emerged as one of the more progressive markets when it comes to SaMD. While the concept of software-based medical tools is hardly new, the country’s formal regulatory recognition of SaMD reflects a deliberate effort to keep pace with the rapid convergence of healthcare and digital technology.

The foundation for SaMD regulation in Japan was set in November 2014 with the enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, commonly referred to as the PMD Act. Among its key provisions, the Act formally classified medical device software, particularly software intended to diagnose and treat diseases, as medical devices. This aligned Japan with international harmonization efforts that other major regulatory bodies were simultaneously pursuing.

The Consultation Pathway

Before any formal approval application is submitted, most SaMD developers will spend considerable time working through PMDA’s consultation framework. The agency offers several layers of consultation, starting with no-cost options like the General Consultation and progressing to fee-based clinical trial consultations for more developed products.

For academic institutions, research organizations, and early-stage ventures, the Regulatory Science (RS) Strategy Consultation deserves particular attention. It is designed for organizations at an earlier stage of development, roughly from the point of selecting product candidates through to early proof-of-concept clinical studies. Qualifying applicants can access this consultation at a reduced fee.

The Approval Review Process

Once a developer is ready to seek marketing approval, the application goes through the PMDA’s review process under the umbrella of the PMD Act. The review encompasses not just the software itself but also compliance assessments for clinical and nonclinical studies (GLP/GCP/GPSP) and Quality Management System (QMS) inspections. The QMS inspection, in particular, ensures that manufacturers have robust systems in place for maintaining the quality and reliability of their products post-approval.

To support greater predictability in the review process, the PMDA has been developing and publishing guidance documents for specific SaMD product categories. These cover areas such as peritoneal dialysis treatment software, dental implant planning support tools, ophthalmic surgery planning software, endoscopic imaging lesion detection software, and computer-aided diagnosis programs for medical image interpretation

DASH for SaMD

The turning point for SaMD regulation in Japan came in November 2020 when the MHLW announced DASH for SaMD, short for DX (Digital Transformation) Action Strategies in Healthcare for Software as a Medical Device. The initiative was a signal that the government viewed SaMD not as a niche product category but as a strategic priority.

In direct response to DASH for SaMD, the PMDA established a dedicated Office of Software as a Medical Device on April 1, 2021. This office was carved out from the existing medical device review offices to allow reviewers to develop deeper expertise in software-specific evaluation challenges, such as algorithm validation, data handling, and the implications of software updates on previously approved functionality.

Priority Review and the SAKIGAKE System

For products considered genuinely breakthrough in nature, two distinct expedited pathways are available.

The first pathway is the SAKIGAKE Designation System, which predates the SaMD-specific Priority Review and applies across all medical products. It targets products that are innovative, address serious conditions, and demonstrate substantially superior efficacy compared to existing options. SAKIGAKE-designated products receive prioritized consultation and review, as well as support in building manufacturing capacity in anticipation of approval.

The second is the Priority Review of SaMD, a trial scheme introduced in 2022. Designated products receive prioritized scheduling for both consultations and review, along with dedicated concierge support from the PMDA. The scheme has been extended and expanded several times since its introduction, and a list of currently designated products is maintained publicly.

Together, these two pathways give the most promising SaMD products a realistic route to earlier market access, which matters enormously in competitive product categories where global launch timing can define commercial success.

Market Opportunity

The SaMD market in Japan is forecast to reach over $95 million by 2033, growing at a 16.9% CAGR. The drivers are familiar: an aging population, rising chronic disease prevalence, and growing demand for remote monitoring and digital care tools. Diabetes management software currently leads by indication, though cardiovascular and mental health applications are gaining ground quickly.

Established Japanese players are already moving. Cyberdyne launched an AI-driven rehabilitation platform in late 2025, Hitachi introduced a machine-learning cardiac diagnostics tool around the same time, and Fujifilm Healthcare is piloting cloud-based AI-assisted radiology.

Key takeaways

Japan’s SaMD market is small compared to the US or EU, but it is growing quickly and the regulatory path, while demanding, is well-defined. The PMDA has invested real effort in making the process more transparent. For SaMD companies approaching the Japanese market for the first time, engaging a local regulatory partner with direct PMDA experience is one of the most effective ways to avoid unnecessary delays.