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 | 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 |
| 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 |
| 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 |
| Document | Language | Number | Published |
|---|---|---|---|
| Japan Foreign Manufacturer Accreditation Instructions | en | JP-008 | Undated |
| 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 |
Below you will find basic demographic and healthcare market data on Japan, plus specific information about the medical device and healthcare indust
read moreAll documents listed below were published by the Ministry of Health, Labour and Welfare (MHLW) or the Pharmaceutical and Medical Devices Agency (PM
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