Japan Medical Device Regulations

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.

Major Regulations

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

General Guidance Documents

DocumentLanguageNumberPublished
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

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

Forms and Applications

DocumentLanguageNumberPublished
Japan Foreign Manufacturer Accreditation Instructionsen JP-008Undated

Additional Information

DocumentLanguageNumberPublished
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

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