Japan Medical Device Regulations

Log into RAMS to download the documents listed below along with more regulations and guidances for Japan.

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Major Regulations
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
General Guidance Documents
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