Japan: A Brief Introduction to SaMD Application: FAQ – September/October 2026

2026-10-26

Question 1: How can we identify whether our software is considered SaMD?

SaMD is defined as "a software that serves a medical purpose and could affect the life or health of a patient (or user) if it does not function as intended". A more detailed explanation can be found in the SaMD applicability guideline (1).

According to the guideline, the following information is necessary for determining whether a software product should be regulated as SaMD:

  • Software configuration and software distribution methods
  • Intended users
  • Intended use
  • Processing methods
  • Processing algorithms
  • Existence of medical devices with equivalent functions

In addition, flow charts for SaMD determination (Attachment 1&2 of Reference 1) and examples of SaMD applicability judgments (2) are provided. These resources can help manufacturers better understand the criteria used for SaMD applicability determinations and assess whether their software is subject to medical device regulation.

Question 2: Are there any guidelines or criteria that can be used as a reference when preparing an application dossier?

1. Certification Criteria

Certification criteria are established for specific generic names. Products classified under these generic names should comply with corresponding certification criteria. If predicate devices with equivalent functions exist, then the product can be certified by a Registered Certification Body (RCB). Certification criteria can be searched using the Generic Name/JMDN Code Database (3).

2. SaMD Review Points

Based on accumulated review experience, PMDA has established review points for SaMD to improve regulatory predictability for manufacturers. These documents summarize key review considerations, including testing requirements and evaluation methods, and other factors relevant to demonstrating safety and effectiveness.

3. Next-Generation Medical Device Evaluation Criteria

The Ministry of Health, Labour and Welfare (MHLW) has been developing evaluation criteria for next-generation medical devices with high medical needs and practical applicability. For SaMD, evaluation criteria for "SaMD Involving Behavioral Change" and "Home-Use SaMD Intended for Disease Treatment" have been published (4) (5).

Question 3: If the software is AI-based, are there any specific regulatory requirements or considerations that we should be aware of?

According to Section 5 of "Review Points for Computer-Aided Diagnosis (CAD) SaMD Intended to Support the Interpretation of Medical Images" (6), due to the nature of machine learning (ML), it is difficult to demonstrate that the quality of the output is assured solely based on the principles (e.g., implemented detection algorithms) and design specifications. Therefore, rather than conducting a detailed examination of the developed neural network, the review focuses on whether appropriate outputs are generated for the device's clinical intention. In order to demonstrate the safety and effectiveness of a device, it is necessary to verify the performance and other relevant characteristics using methods that are medically and statistically sound.

Here are some important notes:

  • Dataset bias should be considered
  • Model bias should be addressed
  • The relationship between training datasets and test datasets should be clarified to avoid bias
  • The generalizability of performance should be assessed
  • Test datasets should include sufficient variation (e.g., patient characteristics, imaging devices, imaging protocols, operators/users)

Further challenges for AI-based SaMD are addressed in "Report on AI-Based SaMD" (7). Manufacturers are encouraged to refer to this report during the design and development process, as it discusses key challenges and considerations associated with AI-based medical device software.

Question 4: Is it possible to consult with PMDA regarding product-specific questions prior to submission?

Yes, PMDA offers several consultation services for manufacturers seeking regulatory advice prior to submission (8). As paid consultations incur fees, manufacturers are encouraged to first take advantage of free consultation services, including General Consultation (全般相談) and SaMD Unified Consultation (SaMD一元的相談窓口). These consultations can help clarify key discussion points.

Understanding a new market often requires both local knowledge and regional experience. With our Japan local offices in Osaka & Yokohama and 26+ years of experience across Asia Pacific, Qualtech supports medical device companies in navigating market regulatory requirements and evaluating growth opportunities. Contact us to discuss your plans for the Japan region.
 

References

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TAG : SaMD , Japan PMDA , MHLW , SaMD applicability , certification criteria , RCB , JMDN code , review points , AI-based SaMD , CAD SaMD , dataset bias , PMDA consultation , home-use SaMD

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