An illustration featuring a central origami figure in gold, symbolizing the concept of 'Software as a Medical Device' (SaMD) against a minimalistic background. The design merges technology and healthcare through an elegant origami representation.


  • Introduction
  • Six-month review process
  • priority registration
  • expanded PMDA support
  • innovative drug consultation
  • early application feedback


Japan’s SaMD and PMDA regulatory framework has evolved quite a lot! From a pragmatic POV, there has been a significant shift towards improving the Japanese registration process’s speed and efficiency. This development is particularly interesting to business leaders and developers eyeing the Japanese market for their SaMD products. The PMDA is central to this transformation, having implemented strategies to expedite SaMD registrations more efficiently and reliably. This initiative aligns with Japan’s commitment to fostering innovation and addressing healthcare needs with high speed. For companies in the rapidly evolving landscape of SaMDs, understanding the PMDA’s modified approach is essential. The agency’s effort to minimize regulatory obstacles and quicken product approvals is a valuable opportunity. International innovators are given the opportunity to significantly impact the Japanese healthcare sector with speed and predictability.

Six-Month Review Process

The PMDA’s introduction of a six-month review process for SaMD applications marks a considerable shift in regulatory practice. Historically, the approval durations for medical devices in Japan could extend significantly by months and even years… This newly established process considerably shortens the timeline for approval. It is similar to the accelerated review mechanisms of the EMA in Europe, aimed at facilitating the availability of innovative therapies for unmet medical needs.

Japan’s expedited review process minimises lag/waiting/idling periods and increases the Japanese healthcare market’s appeal to global innovators and investors. You can expect a more efficient strategic planning and investment decision-making process by facilitating a predictable and fast transition from application to market entry. This change reflects a wider move towards more flexible and responsive regulatory frameworks that can keep up with technological advancements in medicine. For European entities aiming at the Japanese market, this modified process offers a streamlined avenue for delivering innovative solutions to a demographic ready for technological advancements in healthcare.

An origami crane flying through a series of golden gates, symbolizing the expedited six-month review process for SaMD registration in Japan.

Navigating the Fast Track: The Six-Month Review Process for SaMD in Japan.

Through the updated approach of SaMD and PMDA, Japan demonstrates its intent to be at the forefront of digital health innovation. Once again, it highlights a committed effort to refine regulatory processes to benefit innovation and patients. This commitment makes entry into the Japanese market more accessible. It also meets the worldwide need to speed up medical innovations in the fast-paced SaMD industry. As Overseas companies set strategies for entering and expanding within the Japanese market, the PMDA’s six-month review process for SaMD plays a central role in commercial market entry opportunities. It is driving growth in a competitive landscape.

Priority Registration

Establishing a priority registration pathway for SaMD by the PMDA represents a strategic enhancement in the country’s approach to healthcare innovation. This pathway is specifically designed for SaMD products, introducing significant improvements or addressing critical unmet medical needs. There’s a strong dedication to integrating cutting-edge solutions into the healthcare framework. Having a priority status facilitates a faster market entry and amplifies your opportunities.

Understanding this process is necessary when aiming for the Japanese market. The priority system emphasizes the strategic importance of aligning product development with the specific criteria established by the Japanese regulatory framework. This is a proactive stance in fostering an ecosystem for healthcare innovation. It’s a clear invitation to international collaborations and investments in introducing groundbreaking medical technologies.

An origami lotus flower placed prominently on a pedestal, surrounded by other origami figures, illustrating the concept of priority registration for significant SaMD innovations.

Elevating Innovation: Priority Registration for SaMD.

Expanded PMDA Support

Japan’s streamlining of the SaMD registration process is fully aligned with the PMDA. The PMDA has broadened its support for companies navigating this regulatory environment. The expansion includes more in-depth consultation services to guide companies through the application process with an aim at clarity and efficiency. The PMDA has improved their advice on regulatory requirements, submission strategies, and technical documentation to reduce the challenges that risk impede market entry.

This broadened support is a welcomed modernization of Japan’s regulatory approach towards SaMD. Previous practices had limited guidance and were entangled in bureaucratic procedures. The new and enhanced support system is a fantastic opportunity when understanding Japan’s regulatory demands. A smooth approval journey benefits all stakeholders. Local regulatory consultants are still essential also in this new ecosystem. You will still need their expertise in manoeuvring through the PMDA’s procedures, cultural nuances, and linguistic barriers. Everything needs to be in Japanese. As invaluable liaisons, these consultants help your company adapt their submission strategies to comply with all regulatory requirements.

Furthermore, the Marketing Authorization Holder (MAH) concept is integral to Japan’s regulatory framework. The MAH is responsible for the marketing, safety, and quality of a medical product within Japan. For foreign entities, establishing a partnership with a local MAH or engaging the services of a regulatory consultant to fulfil these duties can be a strategic move. Such partnerships ensure adherence to local regulations and facilitate more effective communication with the PMDA, maximizing the benefits of the expanded support to its fullest potential. There are two pathways: You partner with a local company to act as your MAH, or you set up a Japanese subsidiary to act as your MAH.

  • Read our in-depth guide on everything related to MAH here!
Origami figures of a physician consulting a medical device, with digital symbols floating between them, representing the PMDA's support and innovative drug consultation services.

Bridging Ideas and Implementation: PMDA’s Support for SaMD Innovation.

Innovative Drug Consultation

The PMDA has introduced an innovative drug consultation service that significantly enhances the approval process for new drugs, including SaMD. This service is designed to support products that represent significant technological advancements or provide new therapeutic benefits. By engaging early with the PMDA, you can receive critical insights into the regulatory expectations and scientific considerations relevant to your innovative products. This consultation process is especially beneficial for SaMD, where the blend of technology and healthcare presents unique regulatory challenges, and precedents that are not yet easy to draw conclusions from.

Being first means you are meeting with unchartered terrain but also entering a Blue Ocean. That’s what great business opportunities look like! The innovative drug consultation service is a strategic resource to utilize for winners.

Fictional Case Study: Wearable Device for Chronic Heart Condition Monitoring

Let’s illustrate the effectiveness of the innovative drug consultation service provided by the PMDA for SaMD with a fictional case. This case involves a European medical technology company. This company has developed a state-of-the-art wearable device designed to monitor patients with chronic heart conditions remotely. The device utilizes cutting-edge sensors and algorithms to predict, monitor and send alarms of cardiac events. The product acts as a safety device for chronic patients and offers a proactive approach to individual heart disease management.

Seeking to introduce this innovative solution to the Japanese market, the company has already engaged with the PMDA’s innovative drug consultation service at the onset of its regulatory journey. This early decision allows the company to gain valuable insights into Japan’s specific regulatory requirements for SaMD products applied to their unique regulatory journey.

During the consultation, the PMDA provided critical guidance on several key areas:

Interoperability Requirements: The PMDA emphasizes the need for the wearable device to seamlessly integrate with Japan’s existing healthcare infrastructure, ensuring that healthcare professionals can easily access and utilise patient data within the current system.

Adaptation to Japanese Patient Demographics: The PMDA advises tailoring the device’s functionalities to address the Japanese patient population’s age requirements, health trends and expectations, ensuring optimal relevance and utility.

Data Privacy and Cybersecurity: Given the sensitive nature of patient data and Japan’s special laws on data safety, the PMDA outlines the data privacy and cybersecurity standards the device must meet to comply with Japanese regulations. This includes ensuring robust protection against data breaches, unauthorized access and data loss.

Armed with the PMDA’s detailed feedback, the company revised its development strategy to address all requirements. This included adjustments to the device’s software to enhance interoperability with Japanese healthcare systems and modifying its data protocols to meet Japan’s cybersecurity standards.

This fictional case study highlights the tangible benefits of engaging with the PMDA’s innovative drug consultation service when bringing SaMD to the Japanese market. By receiving tailored advice and feedback early in the development process, the company can align its product more closely with Japan’s regulatory and market expectations. This strategic engagement facilitates a smoother and more efficient approval process, significantly reducing time to market and enabling quicker patient access to this innovative remote monitoring solution.

Origami figures of a physician consulting a medical device, with digital symbols floating between them, representing the PMDA's support and innovative drug consultation services.

Bridging Ideas and Implementation: PMDA’s Support for SaMD Innovation.

Early Application Feedback

Another pivotal aspect of Japan’s evolving regulatory framework is the provision of early application feedback for SaMD and PMDA submissions. This initiative allows companies to submit preliminary data and receive feedback from the PMDA before their application is fully completed. This early engagement process is designed to identify potential issues early on and provide guidance on addressing them, thereby streamlining the approval pathway.

This early feedback mechanism is invaluable when venturing into the Japanese market. It offers an opportunity to refine your product in line with real-time regulatory strategies. It’s all based on direct input from the regulatory authority, meaning that guesswork is removed from the equation. This increases the likelihood of approval and minimizes the risk of costly delays. Engaging with the PMDA early in the approval process, even during product development, empowers you to align your SaMD directly with regulatory expectations. This facilitates a smooth and predictable market entry.

The enhancement of early application feedback marks a significant improvement in the registration process for SaMD. Previously, companies had to navigate through a lengthy and uncertain approval process. Challenges included meeting the specific requirements for clinical trials in Japan. With the updated early feedback initiative, you can have a dialogue with the PMDA about your clinical trial plans. They are happy to optimise your strategies to include Japanese participants. This ensures that clinical trial designs align with the outset’s regulatory expectations. This significantly reduces costly delays or the need for additional trials post-submission. This approach accelerates the approval process from invention to market entry. It enhances the efficiency of introducing innovative SaMD products to the Japanese market. It benefits your company with clear guidance and a streamlined regulatory pathway.

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