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Japan Medical Device Regulations

Major Regulations

Japan MHLW Ord. 136 - QA Procedures for Devicesen 1369/2004
Japan MHLW Ord. 169 - QMS Complianceen 16912/2004

General Guidance Documents

Japan Guidance for Medical Device Applications 1 of 2en 02160012/2005
Japan Guidance for Medical Device Applications 2 of 2en 02160022/2005
Japan Handling Medical Device Foreign Clinical Dataen 4793/1997
Japan MHLW Ord. 36 - Good Clinical Practice for Medical Devices en 363/2005
Japan MHLW Ord. 37 - Good Lab Practice Medical Devices en 373/2005
Japan Medical Device Complaint Handling Process Charten JP-001-PPT8/2011
Japan QMS Inspection Process for Medical Devices and IVDen JP-002-PPT12/2010
Japan STED Submission Preparation Handbooken 02160032/2016

Specific Guidance Documents

ISO 13485:2016 Revisions and QMS Surveillanceen ja circular 2016072907/2016
Japan Medical Device Biological Safety Evaluationen 02130012/2003

Forms and Applications

Japan Foreign Manufacturer Accreditation Instructionsen JP-008Undated

Additional Information

Import Q & Aja Import Q & A11/30/2015
Japan Foreign Manufacturer Accreditation Categoriesen JP-007Undated
Japan PMDA Public Release of New Device Applicationsen 02060072/2009

All documents listed below were published by the Ministry of Health, Labour and Welfare (MHLW) or the Pharmaceutical and Medical Devices Agency (PMDA) and are in PDF format.