PMD Act — Key Articles
The Pharmaceuticals and Medical Devices Act (PMD Act / 薬機法, Act No. 145 of 1960 as amended) is Japan's primary legislation governing medical devices. It was originally enacted as the Pharmaceutical Affairs Law (PAL) and renamed by the 2014 amendments.
- Japanese text (authoritative): e-Gov Law Search — Act No. 145
- PMDA English translations (non-official): pmda.go.jp/english/about-pmda/laws-regulations
Structure of the PMD Act
The PMD Act is organised into chapters covering all regulated product types (pharmaceuticals, quasi-drugs, cosmetics, medical devices, and regenerative medicine products). The medical device-specific provisions are spread across multiple chapters, with some shared provisions applying to all product types.
Key chapters relevant to medical devices:
- Chapter II — Business licences (manufacturing, marketing, distribution)
- Chapter IV — Pre-market approval and certification
- Chapter IV-2 — Pre-market approval for regenerative medicine products
- Chapter VI — Labelling and advertising
- Chapter VII — Safety measures (adverse events, recalls)
- Chapter VIII — Supervision and enforcement
Key articles for medical device practitioners
| Article | Subject | Notes |
|---|---|---|
| Article 2(4) | Definition of medical devices | "Instruments, machines, appliances or materials designated by Cabinet Order intended for use in the diagnosis, treatment or prevention of disease in humans or animals, or intended to affect the structure or function of the body" |
| Article 2(5) | Definition of in vitro diagnostics | Separate definition from medical devices; IVDs are regulated in parallel |
| Article 13 | Domestic manufacturing business licence | Requires physical facility in Japan; prefectural or MHLW issued |
| Article 14 | Pre-market approval — Shonin | Application to MHLW; scientific review by PMDA |
| Article 14-2 | Re-examination | Post-approval surveillance and re-examination obligations |
| Article 14-4 | Re-evaluation | MHLW-initiated safety re-evaluation of device categories |
| Article 23-2-5 | Pre-market certification — Ninsho | Certification by Registered Certification Body (RCB) |
| Article 23-2-12 | Pre-market notification — Todokede | Notification for Class I devices; filed with prefectural government |
| Article 23-2-24 | Foreign Manufacturer Registration (FMR) | Registration of overseas manufacturing sites |
| Article 40 | Distribution business licence | Wholesale and retail of medical devices |
| Article 40-2 | Repair business requirements | Licensing for entities repairing medical devices |
| Article 63 | Mandatory labelling requirements | Label elements required for all marketed devices |
| Article 65 | Prohibition on false labelling | |
| Article 66 | Advertising standards — prohibited representations | False/exaggerated claims prohibited |
| Article 68 | Advertising of unapproved products | Advertising a device before it has regulatory clearance is prohibited |
| Article 68-2 | Adverse event reporting | MAH's obligation to report to MHLW |
| Article 69 | MHLW authority to collect safety information | MHLW can require MAHs to provide safety data |
| Article 72 | Recalls and corrective actions | MHLW authority to order recalls; MAH voluntary recall obligations |
| Article 80-8 | Foreign Manufacturer Registration procedure | Procedural basis for FMR system |
Official sources — finding the current text
The authoritative text of the PMD Act is maintained on e-Gov — Japan's official legislative database. The text on e-Gov is updated when amendments take effect.
English translations on the PMDA website are unofficial translations for reference only and may not reflect the most recent amendments. For any regulatory decision, verify against the Japanese text.