
Japanese Medical devices regulation basics
Here below are reported some of the most relevant guidance for Medical Device Registration in Japanese market:
Major Regulations
Regulation | Year |
Japan MHLW Ord. 136 – QA Procedures for Devices | 2004 |
Japan MHLW Ord. 169 – QMS Compliance | 2004 |
General Guidance Documents
Specific Guidance Documents
Document | Year |
ISO 13485:2016 Revisions and QMS Surveillance (english) | 2016 |
ISO 13485:2016 Revisions and QMS Surveillance (japanese) | 2016 |
Japan Medical Device Biological Safety Evaluation | 2003 |
Forms and Applications
Additional Information
Document | Year |
Import Q & A | 2015 |
Japan Foreign Manufacturer Accreditation Categories | Undated |
Japan PMDA Public Release of New Device Applications | 2009 |