Japan Medical Device Regulations
Log into RAMS to download the documents listed below along with more regulations and guidances for 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 |
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