Handling of Medical Device Software in Japan

1. Purpose and Scope

The Handling of Medical Device Software notification (PFSB/MDRMPE Notification No. 1121-33, Nov 21, 2014) provides guidance on how software and storage media with medical device software should be treated under Japan’s Pharmaceuticals and Medical Devices Law. It clarifies the regulatory classification of software and how to determine when software qualifies as a medical device. :contentReference[oaicite:0]{index=0}

This notification applies to software that meets the definition of a medical device under Article 2, Paragraph 4 of the Pharmaceuticals and Medical Devices Act (PMD Act). :contentReference[oaicite:1]{index=1}

2. Definitions

• Software: An assembly of commands input to an electronic computing device designed to obtain a specific result. :contentReference[oaicite:2]{index=2}
• Medical device software: Software that is classified as a medical device. :contentReference[oaicite:3]{index=3}

3. Determining Classification

Whether software is classified as a medical device is determined based on its intended use and whether it falls within the categories listed in the Enforcement Order of the PMD Act, including software for disease diagnosis, treatment, or prevention unless it poses no risk to health. :contentReference[oaicite:4]{index=4}

If the software does not meet these criteria, it is not regulated as a medical device under this notification. :contentReference[oaicite:5]{index=5}

4. Application Requirements

For marketing approval of medical device software, the application must include:

• Appropriate category based on the Enforcement Order’s classification list. :contentReference[oaicite:6]{index=6}
• Generic name consistent with the rules for medical device generic names. :contentReference[oaicite:7]{index=7}
• Clear intended use and clinical indications. :contentReference[oaicite:8]{index=8}
• Detailed description of software operational characteristics, platforms, and performance specifications. :contentReference[oaicite:9]{index=9}

5. Quality Management System (QMS) and Inspections

Medical device software must comply with the Japanese QMS requirements (e.g., Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices). QMS inspections are required for approval/certification or when five years have passed since the last inspection. :contentReference[oaicite:10]{index=10}

6. Labeling and Post-Marketing

Software provided on storage media or through telecommunication lines must meet statutory labeling requirements. If software is provided electronically, labeling must be made accessible before use by users. :contentReference[oaicite:11]{index=11}

Post-marketing requirements such as error/malfunction reporting and recall procedures apply to medical device software in the same manner as other medical devices. :contentReference[oaicite:12]{index=12}

7. Conclusion

This notification lays out foundational regulatory expectations for medical device software in Japan, ensuring safety and consistency with established medical device requirements. :contentReference[oaicite:13]{index=13}