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All PMDA Guidance by Topic

This page indexes the key PMDA and MHLW guidance documents for medical devices, organised by regulatory topic. All guidance links to official PMDA or MHLW sources.

Official source

PMDA guidance (English): pmda.go.jp/english/review-services MHLW guidance (Japanese): mhlw.go.jp — medical devices

Pre-market guidance​

Classification and pathway selection:

  • MHLW notification on medical device classification by JMDN code
  • MHLW notification on Programme Medical Device (SaMD) classification criteria
  • MHLW notification on borderline products — pharmaceuticals vs medical devices

Application dossier:

  • PMDA guidance on STED (Summary Technical Documentation) format for Japan
  • PMDA guidance on Essential Principles checklist structure and content
  • PMDA notification on electronic submission (EDRP) format requirements

Clinical evidence:

  • MHLW notification on the acceptability of foreign clinical data
  • PMDA adoption of IMDRF clinical evaluation guidance (IMDRF/MDCE WG/N56)
  • PMDA guidance on clinical trial design for medical devices
  • PMDA guidance on bridging study requirements

Technical documentation:

  • PMDA guidance on biocompatibility evaluation (ISO 10993-1 alignment)
  • PMDA guidance on software medical devices and IEC 62304 application
  • PMDA cybersecurity guidance for networked and software-enabled devices

Post-market guidance​

Adverse event reporting:

  • MHLW notification on reportable adverse event categories and timelines
  • MHLW notification on periodic summary reporting eligibility
  • MHLW notification on overseas adverse event reporting

GPSP and surveillance:

  • MHLW GPSP Ordinance and implementing notifications
  • PMDA guidance on use-results survey protocol development
  • PMDA guidance on re-examination application content and format

Recalls:

  • MHLW notification on recall classification and notification requirements
  • MHLW guidance on Field Safety Notice content

QMS and manufacturing​

  • PMDA guidance on MO 169 implementation
  • PMDA QMS inspection checklists (published for inspection preparation)
  • MHLW notification on FMR application procedures
  • PMDA guidance on MAH quality oversight system

Digital health and SaMD​

  • MHLW notification on Programme Medical Devices — classification framework
  • MHLW/PMDA guidance on AI/ML medical devices (2021 notification series)
  • PMDA cybersecurity guidance (aligned with IMDRF/CYBER WG/N60)
  • MHLW notification on SaMD post-market change management

IVD-specific guidance​

  • PMDA guidance on IVD performance evaluation requirements
  • MHLW notification on reference range establishment for Japanese population
  • PMDA guidance on IVD clinical performance studies