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 | 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 |