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
Document Number Published Language
Download Japan MHLW Ord. 169 - QMS Compliance 169 12/2004 English
Download Japan MHLW Ord. 136 - QA Procedures for Devices 136 9/2004 English
General Guidance Documents
Document Number Published Language
Download Japan MHLW Ord. 36 - Good Clinical Practice for Medical Devices 36 3/2005 English
Download Japan Guidance for Medical Device Applications 1 of 2 0216001 2/2005 English
Download Japan Guidance for Medical Device Applications 2 of 2 0216002 2/2005 English
Download Japan STED Submission Preparation Handbook 0216003 2/2016 English
Download Japan QMS Inspection Process for Medical Devices and IVD JP-002-PPT 12/2010 English
Download Japan Handling Medical Device Foreign Clinical Data 479 3/1997 English
Download Japan MHLW Ord. 37 - Good Lab Practice Medical Devices 37 3/2005 English
Download Japan Medical Device Complaint Handling Process Chart JP-001-PPT 8/2011 English
Specific Guidance Documents
Document Number Published Language
Download ISO 13485:2016 Revisions and QMS Surveillance circular 20160729 07/2016 English
Download Japan Medical Device Biological Safety Evaluation 0213001 2/2003 English
Download ISO 13485:2016 Revisions and QMS Surveillance circular 20160729 07/2016 Japanese
Forms and Applications
Document Number Published Language
Download Japan Foreign Manufacturer Accreditation Instructions JP-008 Undated English
Additional Information
Document Number Published Language
Download Japan PMDA Public Release of New Device Applications 0206007 2/2009 English
Download Japan Foreign Manufacturer Accreditation Categories JP-007 Undated English
Download Import Q & A Import Q & A 11/30/2015 Japanese