Guideline on Determining Medical Device Classification for Software Programs
Introduction
The Ministry of Health, Labour and Welfare of Japan issued the “Guideline on Determining Medical Device Classification for Software Programs” (Pharmaceutical and Medical Device Agency Notification No. 0331-1 and Pharmaceutical and Medical Device Regulatory Science Bureau Notification No. 0331-15) on March 31, 2021. This guideline establishes clear criteria for determining whether a software program constitutes a medical device and when it does not in an increasingly digitalized healthcare environment where the distinction between software and medical devices has become ambiguous.
In contemporary medical technology settings where the boundary between medical devices and software is frequently unclear, this guideline serves as an essential reference for companies and developers seeking to accurately understand the regulatory positioning of their products. The guideline provides much-needed clarity in an environment where misclassification can lead to significant regulatory consequences.
Framework for Determining Medical Device Classification
Software Programs That Constitute Medical Devices
The guideline clearly defines software programs that qualify as medical devices. These are primarily programs that directly relate to patient care and influence clinical decision-making in diagnosis, treatment, and prevention.
Programs Displaying Disease Candidates and Risk Assessment
Software that displays disease candidates or risk of disease onset based on inputted patient information, test data, biological signals, and other parameters constitutes a medical device. For example, a tool that calculates and displays the risk of cardiovascular disease by inputting patient factors such as age, smoking history, and serum cholesterol levels falls into this category. In this context, the fact that the software provides information that supports medical decision-making becomes a critical factor in determining medical device status.
Programs Intended for Diagnosis, Treatment, or Prevention
Software developed and provided with the explicit intention of diagnosing, treating, or preventing disease is classified based on the clarity of this intent. Even if the software does not generate specific numerical results, if the product labeling, promotional materials, user interface, and other contexts clearly demonstrate an intent toward diagnosis, treatment, or prevention, the software may be classified as a medical device. The clarity of stated purpose and inferred intent from contextual factors becomes paramount in this assessment.
Programs Processing Medical Device-Derived Data
Software that processes data obtained from medical devices—particularly imaging data—and creates indices, processed images, graphs, and other outputs for use in diagnosis or treatment constitutes a medical device. Examples include programs that automatically segment specific organs or lesions from CT or MRI images, or software that identifies tumor regions from digital pathology images. The direct processing of medical device-derived data for clinical application becomes the key determinant of medical device status.
Programs Supporting Treatment Planning
Software that supports treatment planning or treatment method selection, including programs with simulation functionality, is classified as a medical device. Examples include radiation therapy planning software that simulates optimal radiation angles and dose distributions based on patient anatomical data, or orthopedic surgery simulation programs that allow preoperative planning of bone cutting positions and angles. Such programs directly influence clinical decision-making and thus warrant medical device classification.
Programs Controlling Medical Devices or Extending Device Functionality
Software that directly controls medical devices or extends medical device functionality by connecting to medical devices qualifies as a medical device. Since such software and the tangible medical device function together as an integrated system, the software component alone may receive medical device status. Furthermore, software designed to analyze medical device data by connecting to devices and extending their functionality is included in this category.
Programs Used in Conjunction with Tangible Medical Devices
When software is used integrally with tangible medical devices (such as scalpels, pacemakers, or ultrasound probes), the software may receive medical device classification as an ancillary component of the tangible medical device, subject to regulatory assessment of its functional integration and clinical significance.
Software Programs That Do Not Constitute Medical Devices
Software programs that do not constitute medical devices fall into three broad categories: personal use, healthcare professional use, and low-risk functional categories.
Software for Personal Use
Most software programs intended for personal use do not qualify as medical devices. In this classification, the presence or absence of data processing is a critical determinant. Software that only displays, stores, or transfers data without performing substantive data processing or modification does not qualify as a medical device, regardless of the medical nature of the information handled.
Wellness software programs focused on fitness management, nutrition management, sleep tracking, and similar objectives unrelated to medical treatment or disease prevention do not constitute medical devices. Additionally, wellness programs that do not perform data processing or modification and are solely intended for information provision do not qualify as medical devices.
Software for Healthcare Professional Use (Non-Medical Decision Purposes)
Even when used by healthcare professionals, software intended solely for information provision not used in medical decision-making does not constitute a medical device. Examples include software providing general medical knowledge information to physicians and nurses, or medical literature database search functions. These applications support information access rather than clinical decision-making.
Hospital operational support systems and maintenance management software do not qualify as medical devices because they do not directly support clinical practice. Similarly, systems that only store and transfer clinical records without processing do not qualify.
Software that does not process data or performs processing solely for purposes other than diagnosis and treatment does not constitute a medical device. Examples include clinical statistics compilation software or automated billing system software for healthcare administration.
Software Implementing Established Diagnostic and Treatment Guidelines
Software that implements only the processing steps specified in established diagnostic and treatment guidelines requires special consideration in medical device classification. When a guideline’s clinical judgments are mechanically implemented through software programming, the software may be viewed as merely applying established medical knowledge rather than performing independent medical judgment. However, when the software goes beyond mechanical guideline implementation to incorporate comprehensive assessment of multiple parameters or patient-specific adjustment functions, medical device classification may be warranted based on the sophistication of analysis and decision support provided.
Software Equivalent to General Medical Devices
Software that performs processing equivalent to general medical devices (Class I medical devices) does not constitute a medical device for regulatory purposes. Specifically, software that would not pose significant risk to human life or health if functionality errors or malfunctions occurred—that is, software whose processing is limited to low-risk applications despite medical context—falls into this category.
Practical Approach to Medical Device Classification Determination
Several key perspectives are essential when determining medical device classification for software.
Clarity of Intent
Whether diagnostic, therapeutic, or preventive intent can be discerned from the software’s development purpose, product labeling, promotional materials, user manuals, and other contextual information is crucial. Even if not explicitly labeled as a medical device, when such context clearly conveys medical intention, medical device status may be recognized. The totality of circumstances regarding stated and implied purpose forms the foundation of this assessment.
Presence and Nature of Data Processing
Whether the software performs data processing of medical information, and if so, whether such processing directly impacts medical decision-making, constitutes a key criterion. Software limited to display, storage, and transfer functions without substantive processing creates a strong presumption against medical device classification.
User Attributes
Whether the software is used by healthcare professionals or general consumers provides relevant context for classification, but this factor alone does not determine medical device status. Classification requires comprehensive assessment integrating both user category and functional purpose.
Clinical Impact
The degree to which software malfunction or errors could affect patient safety, survival, or health status influences both the determination of medical device status and the risk-based classification level applied. Programs whose failures could result in significant patient harm warrant stronger medical device designation and more stringent regulatory requirements.
Consultation Resources and Support Infrastructure for Software Medical Devices
Since the guideline’s issuance, the number of software medical device development projects has increased substantially. However, determining whether specific products constitute medical devices remains challenging for companies and developers because classification depends on detailed product specifications, intended use, and contextual factors that require individualized assessment.
The Ministry of Health, Labour and Welfare established a comprehensive consultation framework beginning April 1, 2021, to support companies developing software medical devices. This consultation system accepts inquiries regarding medical device classification determination for software, regulatory development considerations for software medical devices, and medical reimbursement questions. The system provides companies with early-stage guidance that informs product development strategy and regulatory planning.
The specific operational details of the consultation system, consultation procedures, and required submission documentation are detailed in related notifications issued by the Ministry. Utilizing this consultation resource enables companies to obtain medical device classification determinations early in development, facilitating strategic decision-making regarding product positioning and regulatory pathways.
International Context and Regulatory Harmonization
In other jurisdictions, including the European Union Medical Device Regulation (MDR) and other international medical device regulatory frameworks, the definition and classification determination processes for standalone software medical devices (Software as a Medical Device, SaMD) have similarly evolved. Japan’s guideline does not substantially diverge from international approaches and instead reflects consensus on core classification elements: medical intent and direct impact on patient outcomes. In this respect, Japan’s regulatory environment aligns with international harmonization trends and provides a relatively balanced regulatory context for companies with global operations.
Conclusion
Medical device classification for software requires comprehensive consideration of development intent, functional capabilities, user category, risk profile, and related factors. Understanding the criteria presented in the guideline and utilizing available consultation resources enables companies to reduce uncertainty regarding medical device classification. As digital healthcare advances, the availability of clear classification criteria becomes increasingly important for the medical device industry, serving as a foundation for promoting innovative software development and deployment in clinical practice. This guideline represents a significant step toward providing regulatory clarity in an evolving technological landscape.
