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.
| 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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