RAPath JP
Japan Medical Device Regulatory Reference — PMDA · MHLW · PMD Act
RAPath JP is a plain English reference for Japanese medical device regulation. It covers the full lifecycle — from classification and pre-market approval through to post-market surveillance, quality management, and the Marketing Authorization Holder (MAH) system.
Why Japan is different
Japan's regulatory framework for medical devices has several features that have no direct parallel in the EU, US, or Australian systems:
Three pre-market pathways. Depending on device class, a manufacturer must choose between Approval (Shonin — for Class III and IV), Certification (Ninsho — for Class II and some Class III), or Notification (Todokede — for Class I). The choice of pathway is determined by device classification and whether a recognised standard exists for the device type.
The MAH requirement. No overseas manufacturer can hold a Japanese approval directly. Every device approval or certification must be held by a Japan-domiciled Marketing Authorization Holder (MAH). This single requirement shapes the market entry strategy for every foreign manufacturer.
QMS Ordinance 169. Japan has its own QMS standard — Ministerial Ordinance 169 — which aligns closely with ISO 13485 but contains Japan-specific additions. Compliance with MO 169 is mandatory and is verified through PMDA and prefectural government inspections.
PMDA and MHLW. Scientific review is conducted by PMDA (the Pharmaceuticals and Medical Devices Agency), but formal approval decisions are issued by MHLW (the Ministry of Health, Labour and Welfare). Understanding how these two bodies interact is essential for navigating the approval process.
How to use this site
| Section | What it covers |
|---|---|
| Start Here | PMD Act definition of a medical device, PMDA vs MHLW roles, the three-pathway system, key stakeholders, device lifecycle, glossary |
| Pre-Market | Classification (Classes I–IV), Shonin approval, Ninsho certification, Todokede notification, clinical evidence, technical documentation |
| Post-Market | Adverse event reporting, recalls, GPSP surveillance, re-examination, labelling requirements, approval changes |
| Quality Management | QMS Ordinance (MO 169), manufacturing licences, Foreign Manufacturer Registration, PMDA inspections |
| MAH & Licences | Marketing Authorization Holder system, Japan domicile requirement, overseas manufacturer pathways, licence maintenance |
| Legislation | PMD Act, Ministerial Ordinances, Cabinet Orders, MHLW notifications, JMDN |
| Guidance | PMDA and MHLW guidance index, recognised standards, forms and portals |
Where to start
- New to Japan regulation? → What is a Medical Device?
- Need the right pathway? → Approval vs Certification vs Notification
- Classifying a device? → How Classification Works
- Overseas manufacturer? → What is an MAH?
- Reporting an adverse event? → What Must Be Reported