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Software Documentation (IEC 62304)

IEC 62304 in Japan​

IEC 62304 (Medical device software — Software life cycle processes) is a recognised standard in Japan. PMDA expects software-enabled devices and Programme Medical Devices to have software lifecycle documentation that complies with IEC 62304.

Key IEC 62304 requirements that must be evidenced in the application dossier:

  • Software safety classification (Class A, B, or C) based on the severity of harm from software failure
  • Software requirements — documented requirements for the software system
  • Software architecture — documented architecture supporting risk-based design
  • Software testing — unit, integration, and system-level testing plans and reports
  • Software problem resolution process — how defects identified post-market are managed

Software lifecycle documentation in the dossier​

The application does not require submission of the complete software lifecycle documentation (which may be thousands of pages). Instead, a summary is required that demonstrates:

  1. The software safety classification and rationale
  2. That the development lifecycle followed IEC 62304
  3. Key verification and validation testing results
  4. Any known software deficiencies and how they are managed

The full software lifecycle documentation is reviewed during QMS inspection, not application review.

Cybersecurity requirements​

PMDA and MHLW have issued guidance on cybersecurity for networked and software-enabled devices, drawing from IMDRF's cybersecurity guidance (IMDRF/CYBER WG/N60). Required documentation includes:

  • Security risk assessment identifying cybersecurity threats and vulnerabilities
  • Security controls implemented in the device design
  • Plans for post-market cybersecurity monitoring and vulnerability management
  • Labelling information for users about cybersecurity requirements (e.g. minimum OS version, patch requirements)

Cybersecurity documentation is a priority for PMDA. Requirements have been clarified through recent MHLW/PMDA guidance documents. Applicants must consult the latest PMDA cybersecurity guidance (available on the PMDA website and aligned with IMDRF/CYBER WG guidance) before finalising submissions, as expectations continue to strengthen.

Programme Medical Devices (プログラム医療機器) are software-based medical devices or functions embedded in non-medical devices. These are subject to the same IEC 62304 requirements as traditional software-enabled devices.