Regulatory Framework Overview

Japan's medical device regulatory framework is built on a hierarchy of legislation, ordinances, and administrative guidance. Understanding this hierarchy is essential because different documents carry different legal weight, and requirements may be found at any level.

The legislative hierarchy

PMD Act (Act No. 145, 1960)
     │
     ├── Cabinet Orders (政令)
     │       Issued by Cabinet; define device categories, 
     │       fee structures, and certain procedures
     │
     ├── Ministerial Ordinances (省令)
     │       Issued by MHLW Minister; set detailed requirements
     │       for manufacturing, labelling, clinical trials
     │       → QMS Ordinance (MO 169)
     │       → Labelling Ordinance
     │       → GCP Ordinance for devices
     │
     └── MHLW Notifications (通知 / 告示)
             Administrative guidance issued by MHLW
             Explain how the above apply in practice
             Not legally binding in the same way as legislation,
             but operationally essential — PMDA follows them

Primary legislation — PMD Act

The PMD Act (Act No. 145 of 1960) is the foundation. It defines medical devices, establishes the pre-market pathway structure, sets out post-market obligations (adverse event reporting, recalls, re-examination), and gives MHLW its enforcement powers.

The PMD Act cannot be changed without action by the National Diet (Japan's parliament). Major amendments — such as those in 2014 and 2019 — require full legislative process.

Cabinet Orders

Cabinet Orders (政令 — seirei) are issued by the Cabinet without requiring Diet approval. For medical devices, the most important Cabinet Order defines:

• The specific categories of products classified as medical devices (the list that makes the general PMD Act definition operational)
• The specific categories classified as specially controlled medical devices (Class III and IV)
• Application fees

Cabinet Orders are legally binding.

Ministerial Ordinances

Ministerial Ordinances (省令 — shōrei) are issued by the MHLW Minister and set out the detailed technical and procedural requirements. The most important for medical devices are:

• MO 169 — QMS Ordinance (quality management system requirements for device manufacturers)
• Labelling Ordinance — mandatory label elements and IFU requirements
• GCP Ordinance for Devices — Good Clinical Practice requirements for device clinical trials in Japan

Ministerial Ordinances are legally binding.

MHLW Notifications

MHLW Notifications (通知 — tsūchi, or 告示 — kokuji) are administrative documents that explain how the PMD Act, Cabinet Orders, and Ministerial Ordinances are to be applied in practice. They are issued by MHLW or PMDA and cover topics such as:

• Which standards are accepted for use in applications
• Detailed guidance on application dossier structure
• Specific requirements for particular device types
• Administrative procedures (consultation booking, form submission)

Notifications are not legally binding in the same way as legislation, but PMDA reviewers and RCBs apply them as if they were. Departing from a notification without PMDA agreement is unlikely to result in a successful application.

Recognised standards

MHLW maintains and publishes a list of recognised standards (認証基準) — domestic and international standards designated by MHLW as acceptable for demonstrating conformity with Essential Principles. Devices for which a recognised standard exists may be eligible for the Ninsho (certification) pathway rather than full Shonin (approval).

The list is updated periodically and is available from MHLW's website.

JMDN — Japan Medical Device Nomenclature

Every medical device in Japan must be assigned a JMDN code — a Japan Medical Device Nomenclature code. JMDN codes are managed by MHLW and are used throughout the regulatory process to identify device types, determine applicable standards, and link devices to recognised standards for Ninsho eligibility.

See JMDN — Nomenclature and Device Codes for details.

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