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

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

General Guidance Documents

Document	Year
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

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

Document

Japan Foreign Manufacturer Accreditation Instructions

Additional Information

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

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