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PMDA Notifications and Administrative Notices

PMDA's notice system​

PMDA issues its own administrative notices (通知 and 事務連絡 — jimu renraku) separate from MHLW notifications. PMDA notices cover procedural and technical details within PMDA's operational scope, including:

  • Electronic submission format requirements for PMDA's gateway
  • Pre-submission consultation booking procedures and templates
  • Specific technical guidance for particular device categories
  • QMS inspection procedures and checklists

PMDA notices do not have the same formal status as MHLW notifications, but they are operationally essential for anyone interacting with PMDA's review or inspection processes.

Key PMDA notices for medical device applications​

Electronic submission​

PMDA has published detailed requirements for electronic submission via its EDRP gateway, including:

  • File naming conventions
  • Document structure requirements
  • Module organisation
  • XML data specifications for structured sections

These requirements are published on PMDA's website and are updated periodically.

Pre-submission consultation guidance​

PMDA publishes guidance on:

  • How to book consultation appointments
  • Required consultation briefing document format
  • What information to prepare for different types of consultation
  • How meeting minutes are prepared and approved

QMS inspection checklists​

PMDA publishes checklists used by its inspection team, providing insight into which MO 169 elements are scrutinised most closely. These are invaluable for inspection preparation.

Official source

PMDA administrative notices: pmda.go.jp — administrative guidance (primarily Japanese; some English sections)

This gateway is called PMDA's e-submission system. Current requirements and file format specifications are published at pmda.go.jp/english/review-services/submission/form-submission/ (English overview) and the Japanese guidance at pmda.go.jp/review/mreview (Japanese details).