Japan Medical Device Regulations
Log into RAMS to download the documents listed below along with more regulations and guidances for Japan.
Related services for Japan:
- Foreign Manufacturer Registration in Japan
- Medical Device Classification and JMDN Codes in Japan
- PMDA Medical Device Registration and Approval in Japan
- Quality Management System Compliance - Japan Ordinance 169
Related resources:
- Japan's Pharmaceutical and Medical Devices Act (PMD Act)
- Japan PMDA Approval Process for Medical Devices
- Japan’s Pharmaceuticals and Medical Devices Agency
- Medical Device Executive Guide to Japan
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Log in | MHLW Ordinance No. 169 (Japanese Quality Management Systems) | 169 | English | |
| Log in | Pharmaceuticals and Medical Devices (PMD) Act | 1960 | English |
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Log in | Order for Enforcement of the PMD Act | English | ||
| Log in | Enforcement Regulations of the PMD Act | English | ||
| Log in | JDMN Code English Database | English | ||
| Log in | MHLW Ordinance No. 135 (Good Vigilance Practice) | 135 | English |
