Key MHLW Notifications Index

What MHLW notifications are

MHLW notifications (通知 — tsūchi, or 告示 — kokuji) are administrative guidance documents issued by MHLW (or by PMDA as administrative notices). They explain how the PMD Act, Cabinet Orders, and Ministerial Ordinances are to be applied in practice.

Legal status: Notifications are not legislation — they cannot create obligations that go beyond the PMD Act or Ministerial Ordinances. However, PMDA reviewers and RCBs apply them in practice as binding requirements. An application that departs from MHLW notification guidance without adequate justification is unlikely to succeed.

How to read a notification reference number

Notifications are cited by:

• Issuing bureau/department
• Issue date (year, month, day in Japanese era format or Western calendar)
• Number within that year

Example: 薬機発0401第1号 (Yakki-hatsu 0401 No. 1) = Notification No. 1 issued on April 1 by the Pharmaceutical and Food Safety Bureau.

Index of key notifications for medical devices

Classification and pathway

Topic	Key notification
Recognised standards list for Ninsho	Updated periodically — check current MHLW publication
Programme Medical Devices (SaMD) classification	MHLW notification on software classification guidance
Borderline product determinations	Multiple notifications on specific borderline categories

Pre-market applications

Topic	Key notification
STED application format	PMDA notification on electronic submission requirements
Essential Principles checklist format	MHLW notification specifying checklist structure
Clinical evaluation for devices — IMDRF alignment	MHLW notification adopting IMDRF clinical evaluation guidance
Foreign clinical data acceptability	MHLW notification on conditions for accepting foreign data

Post-market

Topic	Key notification
Adverse event reporting — what is reportable	MHLW notification specifying reportable event categories
GPSP survey implementation guidance	MHLW/PMDA notification on GPSP implementation
Re-examination application format	PMDA notification on re-examination submission requirements

QMS and manufacturing

Topic	Key notification
MO 169 implementation guidance	PMDA notification clarifying MO 169 requirements
FMR application procedures	MHLW notification on FMR application process

Official source

All MHLW notifications: mhlw.go.jp — pharmaceutical notifications (Japanese) PMDA administrative notices: pmda.go.jp — administrative information (some available in English)

Note: Specific notification numbers, dates, and issuing bureaus are not listed here because they change with periodic updates. Always verify the current version on mhlw.go.jp by searching for the topic (e.g., "認証基準" for recognised standards or "プログラム医療機器" for SaMD) rather than relying on stored notification numbers.