Quality Management Systems (QMS) in Japan with Ministerial Ordinance 169

In Japan, medical device applicants (Class II-IV and those Class I devices designated by the MHLW) for product registration must demonstrate QMS compliance. Ministerial Ordinance 169 was issued in December 2004 and is the Standard of Manufacturing Control and Quality Control for both Medical Devices and In-vitro Diagnostic reagents. This ordinance is the main regulation specifically listing QMS requirements.

QMS has some differences with ISO 13485. These differences are evident in the application, document control, record control, responsible engineering manager, infrastructure, etc. For example, there may be different requirements for the length of time required to keep copies of documents.

For more information on Japanese medical device quality standards, please see the following PBM publications and/or contact us to discuss your specific needs.

Japan Medical Device Updates (webcast for sale)
Updates on Japan's Expanding Medical Device Market (webcast for sale)
Lost in Translation: The Challenges of a QMS Audit
Japan Quality Audits 2009 (publication for sale)
Japan QMS Audit for Medical Device Registration (webcast for sale)

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