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.

PMDA Administrative Notices (事務連絡): Available on PMDA's website under "Administrative Information" (行政情報) or "Guidance Documents" (ガイダンス). These are often in Japanese only; English translations are not systematically provided.