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Japan Quality Management System Compliance - Ordinance #169

Japan's Pharmaceutical and Medical Device Act (PMD Act) and Ministerial Ordinance #169 issued by the Ministry of Health, Labour and Welfare (MHLW) states that Marketing Authorization Holders (MAH) must adhere to specific quality management system (QMS) requirements.

Foreign Manufacturer and MAH QMS audits

According to the PMD Act, manufacturing facilities registered under an MAH are subject to a QMS conformity assessment as part of the Japanese registration process. However, if you as a foreign manufacturer have adopted the Foreign Special Approval System and are the holder of pre-market approvals or certifications, you will undergo QMS conformity assessment instead of the MAH.

QMS conformity assessments are conducted by the Pharmaceuticals and Medical Devices Agency (PMDA) or a Registered Certification Body (RCB). After a successful assessment, a certificate of QMS Conformance (“KijunTekigoshou”) will be issued and are valid for five years.

Relationship of Ordinance #169, ISO 13485 and Japanese PMD Act

Fortunately, Japan has largely embraced ISO 13485 as the basis for their QMS requirements. Manufacturers with ISO 13485 in place will find meeting Ordinance #169 to be reasonably straightforward by adjusting some gaps between ISO13485 and Ordinance #169.

We can assist with QMS compliance in Japan

Emergo can assist you in meeting Japan’s quality system requirements of Ordinance #169 so you can begin the process of obtaining approval from the PMDA or RCB. We will:

  • Review your quality manual and prepare a gap analysis with references to the appropriate clauses of Ordinance #169.
  • Prepare supplemental documents as an appendix of the quality manual
  • Create and propose changes needed to meet the Japan QMS regulation including the Japan Technical File as Manufacturing Standard (Seihinhyojunsho).
  • Conduct a mock assessment of your quality system
  • Prepare and submit the QMS Conformity Assessment application on your behalf.

A global understanding of overlapping QMS regulations

Emergo understands how the quality system requirements of Japan, Korea, Europe, Canada, Australia and the US overlap and differ from one another. In addition to quality system compliance, we can also assist you with ISO 13485 and FDA QSR compliance.

Please contact us for more information on QMS consulting for Japan and markets worldwide.

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Listen to our 7 minute audio podcast discussing compliance with Japanese Ordinance 169: 

Interested in learning more about Japan's complex QMS requirements? Mic Miyahara, CEO of Emergo Japan, answers some of our most frequently asked QMS questions in this podcast interview.