Cabinet Order — Device Categories and Definitions
Role of Cabinet Orders in the PMD Act framework
Cabinet Orders (政令 — seirei) are secondary legislation issued by the Japanese Cabinet. They sit between the PMD Act (which requires Diet approval to amend) and Ministerial Ordinances (which only require the MHLW Minister's signature). Cabinet Orders can be amended by Cabinet decision without Diet involvement, making them a more flexible tool for updating device classification lists.
For medical devices, the key Cabinet Orders:
- List the specific product categories designated as medical devices (making the general PMD Act definition operational)
- List product categories designated as specially controlled medical devices (Class III and IV)
- Set regulatory fees for applications and licences
The Cabinet Order designating medical device categories
The Cabinet Order on Specially Controlled Medical Devices (高度管理医療機器等の指定) lists the specific device types classified as Class III and IV (Specially Controlled Medical Devices). This list directly determines:
- Which devices require Shonin approval (Class III/IV)
- Which devices may be eligible for Ninsho certification (some Class III on a designated list)
- Which devices are subject to the highest post-market surveillance requirements
The Cabinet Order is updated periodically as new device types are developed and classified, or as existing devices are reclassified based on accumulated safety data.
Enforcement Regulations
The PMD Act Enforcement Regulations (薬事法施行規則) are technically a Ministerial Ordinance-level instrument but are sometimes grouped with Cabinet Orders in regulatory literature. They set out procedural details for licensing applications, application forms, and administrative processes referenced in the PMD Act.
Current Cabinet Orders: e-Gov Cabinet Order database (search 高度管理医療機器 Cabinet Order)