PMD Act — the Legal Definition
Japan's PMD Act combines pharmaceuticals, medical devices, and regenerative medicine products in a single statute. This structure has no direct parallel in EU MDR, FDA 510(k)/PMA, or TGA frameworks, which have separate legislation for each product type.
What the PMD Act is
The Pharmaceuticals and Medical Devices Act (医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律) — commonly abbreviated as the PMD Act — is Act No. 145 of 1960, as extensively amended. Its full title translates to "Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices."
The PMD Act governs:
- Pharmaceuticals
- Quasi-drugs
- Cosmetics
- Medical devices (including IVDs and SaMD)
- Regenerative medicine products and cellular/gene therapy products
For medical devices, the PMD Act establishes the legal basis for classification, pre-market approval and certification, manufacturing and distribution licensing, post-market surveillance, adverse event reporting, recalls, and enforcement.
History and the 2014 rename
The law was originally enacted as the Pharmaceutical Affairs Law (PAL) (薬事法) in 1960. The 2014 amendments renamed it to the PMD Act and introduced major structural changes specifically for medical devices:
- The three-pathway system (Shonin / Ninsho / Todokede) was established in its current form
- A dedicated framework for regenerative medicine products was created
- The Marketing Authorization Holder (MAH) concept was refined
- A new framework for Programme Medical Devices (software as a medical device) was introduced
Prior to 2014, medical devices and pharmaceuticals used more similar regulatory pathways. The 2014 changes recognised the distinct nature of medical device regulation and moved it closer to international standards (particularly GHTF/IMDRF).
Key articles for medical device practitioners
| Article | Subject |
|---|---|
| Article 2(4) | Definition of medical devices |
| Article 2(5) | Definition of in vitro diagnostics |
| Article 13 | Manufacturing business licence (domestic) |
| Article 14 | Pre-market approval — Shonin |
| Article 23-2-5 | Pre-market certification — Ninsho |
| Article 23-2-12 | Pre-market notification — Todokede |
| Article 40-2 | Repair business requirements |
| Article 63 | Labelling obligations |
| Article 68-2 | Adverse event reporting |
| Article 69 | MHLW collection of adverse event information |
| Article 72 | Recalls and corrective actions |
| Article 80-8 | Foreign Manufacturer Registration |
Where to find the current text
- Japanese (authoritative): e-Gov Law Search
- English translation (non-official): PMDA English page
Note that English translations on the PMDA website may lag behind the most recent amendments. Always verify the Japanese text for the most current version before relying on the English translation for a regulatory decision.