Legislation and Regulations
The full legislative stack governing medical devices in Japan — from the PMD Act at the top through to the MHLW notifications that explain day-to-day application. Understanding this hierarchy is essential because requirements can be found at every level, and each level carries different legal weight.
The hierarchy at a glance
| Level | Examples | Legal weight |
|---|---|---|
| PMD Act | Act No. 145 of 1960, as amended | Highest — requires Diet (Parliament) to amend |
| Cabinet Orders | Device category listings, fee structures | Legally binding — issued by Cabinet |
| Ministerial Ordinances | MO 169 (QMS), Labelling MO, GCP MO | Legally binding — issued by MHLW Minister |
| MHLW Notifications | Application guidance, standards lists | Operationally binding — administrative guidance |
| PMDA Administrative Notices | Submission format, consultation procedures | Procedural guidance from PMDA |