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