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.
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 |
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 |
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 |
Document | Number | Published | Language | |
---|---|---|---|---|
Download | Japan Foreign Manufacturer Accreditation Instructions | JP-008 | Undated | English |
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 |
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