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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.

Official source

Full notification database: mhlw.go.jp — pharmaceutical notifications Search by topic area or date range. Note: the notification database is in Japanese only.

"Unique Device Identification (UDI): MHLW notifications specify Japan's UDI implementation requirements, including GTIN, lot/serial number formats, and labelling placement for devices sold in Japan. Timeline for mandatory UDI compliance varies by device class. Check current MHLW notifications for your device's UDI deadline."