Skip to main content

How to Read Japanese Legislation

JP-unique

Japanese legislation is structured differently from EU, US, and Australian law. The hierarchy — Acts, Enforcement Regulations, Cabinet Orders, Ministerial Ordinances, Notifications — means that important requirements may be found at different levels. Understanding how to navigate this hierarchy is essential for anyone working with Japan device regulation.

The Japanese legislative hierarchy​

Constitution of Japan
    │
    └── National Diet (Parliament) — enacts Acts (法律)
            │
            └── PMD Act (薬機法) — Act No. 145 of 1960 as amended
                    │
                    ├── Cabinet Orders (政令) — issued by Cabinet
                    │       Device category designations
                    │       Fee structures
                    │
                    └── Ministerial Ordinances (省令) — issued by MHLW Minister
                            QMS Ordinance (MO 169)
                            Labelling Ordinance
                            GCP Ordinance for Devices
                            │
                            └── MHLW Notifications (通知 / 告示)
                                    Procedural and technical guidance
                                    Recognised standards designations
                                    Application format requirements
                                    │
                                    └── PMDA Administrative Notices (事務連絡)
                                            Operational procedures
                                            Submission format details

How to find a specific provision​

When a PMDA reviewer or MHLW official cites a regulatory requirement, they will typically reference:

  • The PMD Act article (e.g. "Article 68-2")
  • The relevant Ministerial Ordinance article (e.g. "MO 169 Article 63")
  • The relevant MHLW notification (cited by bureau, date, and number)

To find the provision:

  1. PMD Act: Search e-Gov (laws.e-gov.go.jp) for the PMD Act by its title or act number
  2. Ministerial Ordinances: Also on e-Gov; search by ordinance name
  3. MHLW Notifications: On the MHLW website under the relevant policy area (pharmaceutical/medical device)
  4. PMDA notices: On the PMDA website under "Guidance" or "Administrative Information"

Finding official English translations​

PMDA maintains an English-language section of its website with unofficial English translations of key legislation: pmda.go.jp/english/about-pmda/laws-regulations

Note: English translations lag behind the most recent amendments. For regulatory decisions, always verify against the Japanese text.

e-Gov — Japan's official legislation database​

e-Gov Law Search is Japan's official, free, publicly accessible database of all current legislation. Features:

  • Full text of Acts, Cabinet Orders, and Ministerial Ordinances in their current consolidated form
  • Amendment history showing when each provision was changed
  • Search by law name, article number, or keyword (Japanese only)

e-Gov is the authoritative source for current legislative text.