Japan Regulatory Framework Medical Device registration

Japanese Medical devices regulation basics

Here below are reported some of the most relevant guidance for Medical Device Registration in Japanese market:

Major Regulations

Japan MHLW Ord. 136 – QA Procedures for Devices 2004
Japan MHLW Ord. 169 – QMS Compliance 2004

General Guidance Documents

Japan Guidance for Medical Device Applications 1 of 2 2005
Japan Guidance for Medical Device Applications 2 of 2 2005
Japan Handling Medical Device Foreign Clinical Data 1997
Japan MHLW Ord. 36 – Good Clinical Practice for Medical Devices 2005
Japan MHLW Ord. 37 – Good Lab Practice Medical Devices 2005
Japan Medical Device Complaint Handling Process Chart 2011
Japan QMS Inspection Process for Medical Devices and IVD 2010
Japan STED Submission Preparation Handbook 2016

Specific Guidance Documents

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

Japan Foreign Manufacturer Accreditation Instructions

Additional Information

Import Q & A 2015
Japan Foreign Manufacturer Accreditation Categories Undated
Japan PMDA Public Release of New Device Applications 2009


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