Japan Quality Management System Compliance - MHLW Ordinance #169
Emergo Group can assist medical device companies in modifying their existing Quality Management System (QMS) to meet the Japanese quality system requirements.
Japan's Pharmaceutical Affairs Law (PAL) of 2005 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 specializes in assisting companies with implementation of ISO and Good Manufacturing Practices (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 Ordinance #169 so you can begin the process of obtaining approval to market your medical devices from the Japanese Pharmaceutical and Medical Devices Agency (PMDA).
Please contact us for more information or a free proposal on our quality management system compliance consulting services for Japan.
