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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 Doubts?
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Doubts ?
Reach out to us and we will help you clarify your situation