Japan is the fourth-largest global medical device market, with its healthcare system actively integrating digital tools as part of its national care infrastructure. SaMD was once treated cautiously, however, the industry now benefits from clearer regulatory pathways, pilot reimbursement mechanisms, and a growing appetite for tech-enabled chronic care management.
While many non-Japanese companies focus on “getting approval,” the more decisive factor for long-term viability is what happens after the PMDA green light. This blog post lays out where the real opportunities hide, the inflexion points SaMD companies should anticipate, and how foreign innovators can effectively build commercial traction in Japan.
From regulation to revenue: Key stages in Japan’s SaMD commercialization journey.
Regulatory Compliance Is Not the Goal: It’s the Entry Ticket
The path toward SaMD commercialisation in Japan begins with the regulatory hurdle. We think it makes more sense to view it as a gatekeeping mechanism that favours successful companies. The PMDA and MHLW have jointly developed a multi-tier classification model (Class I–IV), risk-based yet increasingly SaMD-specific, defining the required review depth.
Foreign companies must work through a local MAH or Designated MAH (DMAH), who is fully responsible for product performance, safety, and post-market surveillance. Importantly, Japan’s “Priority Review for Program Medical Devices” facilitates faster market access for novel or globally synchronised launches.
However, successful market entry begins before submission. A Japan-specific clinical strategy, particularly for behavioral-change-inducing DTx apps, remains critical. Trials must align with local GCP standards and cultural expectations around data and care pathways.
In essence, the regulatory stage in Japan filters for commitment, not just innovation.
SaMD and PMDA – Japan’s Fast Track Policies to Expedite SaMD Registration
This blogpost focuses on Japan’s six-month review process and regulatory reforms, offering essential background on how the PMDA is streamlining SaMD approvals.Regulatory Topics Archive – Biosector
This archive includes multiple blog posts on SaMD, digital health, and regulatory strategy in Japan.
Reimbursement: Where Japan Leads in Global Digital Health
One of Japan’s defining features is its progressive movement toward reimbursement for SaMD products. Unlike in most countries, the MHLW and the Central Social Insurance Medical Council (Chu-I-Kyo) have formalised pathways to review and price SaMDs, particularly digital therapeutics and AI-based diagnostics.
Case in point: CureApp SC, Japan’s first DTx product approved for smoking cessation, was also the first to receive public insurance coverage. This wasn’t an anomaly as it established a precedent. Products that address chronic disease, are evidence-based, and deliver measurable outcomes are candidates for this unique dual approval-and-reimbursement route.
The evaluation process involves an expert panel and a formal health technology assessment (HTA). Companies must be prepared with both efficacy data and robust economic models proving system-wide benefit.
This makes Japan an unusually compelling environment when you are seeking early revenue realisation. Your pricing strategy is considered alongside regulatory workstreams from day one.
Integrating digital therapeutics into Japan’s hospital, clinic, and home-based healthcare systems.
Integrating into Japan’s Health Delivery Architecture
Once approval and reimbursement are in hand, the next challenge is placement within Japan’s diverse and ageing-focused healthcare delivery system. SaMD commercialisation in Japan succeeds when deployment reflects the country’s dual model: centralised hospital-based care and a growing emphasis on home and preventive care.
SaMDs that support remote monitoring, self-managed rehabilitation, and chronic disease support are particularly well-positioned. The COVID-19 pandemic catalyzed new reimbursement categories for telemedicine and digital monitoring, and this structural shift continues.
Deployment routes often include:
Integration via hospitals using diagnostic support systems (CDSS, AI imaging tools).
Use in outpatient clinics for conditions like hypertension, diabetes, and post-stroke rehab.
Direct-to-consumer strategies for approved self-management tools.
This makes for a complex yet navigable sales matrix — but only when localization, training, and post-sales support are fully embedded in the commercial plan.
Digital Health in Japan written by Biosector
A curated list of posts tagged under digital health, including SaMD-related insights.
The Multiplier Effect of the Right Japanese Partner
For most SaMD companies entering Japan, the choice of local partner is one of the highest-leverage decisions they’ll make. While some large corporations opt for direct entry, the majority of successful cases involve partnerships with distribution experts, healthtech CROs, or hybrid DMAH-commercial players.
These partners bring not only regulatory execution but deep cultural fluency — essential for engagements with providers, payers, and patients. They also open doors to pilot deployments, academic co-validation, and in some cases, government-backed demonstration programs.
Japan rewards consistency and relationship-based business development. A successful partner not only understands the buyer dynamics but actively shapes them through KOL engagement, regional pilots, and active feedback loops with MHLW when considering reimbursement extensions or new use cases.
Direct control may be appealing, but distributed trust often scales faster.
Essential preparations for successful SaMD commercialisation in Japan.
Cheatsheet – What SaMD Innovators Must Finalise Before Taking Action
Before initiating SaMD commercialisation in Japan, your company need to align internally on five essential areas:
Localisation Strategy: Beyond translation — include UI/UX tweaks, data governance adaptations, and cultural alignment in behaviour-based interventions.
Clinical Pathway Compatibility: Ensure the SaMD fits within Japan’s treatment guidelines and physician workflow. Off-path tools will struggle to gain adoption.
Reimbursement Positioning: Build economic evidence early. Without a reimbursement path, scaling will be difficult.
Post-Market Surveillance and Support: Japan requires meticulous tracking of usage data, adverse events, and real-world effectiveness. Who will handle that locally?
Partnering Framework: Have clear criteria for selecting, incentivizing, and supporting Japanese partners — or prepare for the long road of direct deployment.
These preparations shift the focus from whether your company can enter Japan to how you will scale commercially once you do.
We have supported cross-border life science commercialisation in Japan for almost 20 years and are eager to explore your needs and expectations. You are warmly welcome to book a meeting directly with us here: https://www.calendly.com/biosector or send an email to info@biosector.jp
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