MHLW Notifications Index
MHLW notifications (通知 — tsūchi) and related administrative guidance documents are the operational rulebook for Japan device regulation. They translate the PMD Act and Ministerial Ordinances into specific, actionable requirements.
How notifications are published
MHLW notifications relevant to medical devices are published by:
- Pharmaceutical Safety and Environmental Health Bureau (医薬・生活衛生局) — primary issuer of device-related notifications
- Pharmaceutical Affairs Office within the bureau (医療機器審査管理課) — device-specific applications and approvals
PMDA also issues administrative notices (事務連絡) that clarify procedural matters.
Key notification categories for medical devices
Classification and nomenclature
Notifications that update the JMDN code list, add new device categories, or reclassify existing categories. Published when new device types emerge or Cabinet Order classifications are updated.
Recognised standards designation
Notifications that add, update, or remove standards from the recognised standards list for Ninsho eligibility. Updated periodically — essential to check for current status of any standard you plan to use.
Application procedures
Notifications specifying the format, content, and process for Shonin, Ninsho, and Todokede applications. Includes PMDA's electronic submission requirements.
Clinical and technical requirements
Notifications on clinical evaluation, foreign data acceptance, performance testing requirements for specific device categories, and biocompatibility evaluation.
Post-market requirements
Notifications on adverse event reporting, GPSP implementation, re-examination procedures, and recall processes.
Labelling
Notifications specifying IFU content requirements, UDI implementation timelines, and special labelling rules for device categories.
Full notification database: mhlw.go.jp — pharmaceutical notifications Search by topic area or date range. Note: the notification database is in Japanese only.