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