Japan Quality Management System Compliance - MHLW Ordinance #169

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Emergo Group can assist medical device companies in modifying their existing Quality Management System (QMS) to meet the Japanese quality system requirements.

Relationship of Ordinance #169, ISO 13485 and Japanese PAL

Japan's Pharmaceutical Affairs Law (PAL) and Ministerial Ordinance #169 issued by the Ministry of Health, Labour and Welfare (MHLW) specify the requirements. Fortunately, Japan has largely embraced ISO 13485 as the basis for their quality management system (QMS) requirements and thus manufacturers with ISO 13485 in place will find meeting Ordinance #169 to be reasonably straightforward. There are additional requirements for defining the role of the Marketing Authorization Holder (MAH), retention of records and infrastructure. We can assist you in meeting these additional requirements.

Emergo Group can assist you in the following areas of QMS compliance for Japan:

Gap Analysis - We review your quality manual and prepare a matrix showing gaps 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).
Mock assessment of your quality system
Prepare and submit the QMS Conformity Assessment application

Emergo Group specializes in assisting companies with implementation of ISO 13485 and Good Manufacturing Practice (GMP). We understand how the requirements of Japan, Europe, Canada, Australia and the US overlap, and how they differ from one another. Emergo is uniquely qualified to help you meet the additional quality system requirements imposed by MHLW Ordinance #169 so you can begin the process of obtaining approval to market your medical devices from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).