Understanding Japan's Pharmaceutical Affairs Law - Requirements regarding Quality Management Systems

Understanding Japan's Pharmaceutical Affairs Law - Requirements regarding Quality Management Systems

On July 25, 2002, the Japanese House of Representatives passed and enacted the revised Pharmaceutical Affairs Law (PAL). The original PAL dates back to 1943, with subsequent revisions in 1948, 1960, and 1979. However, the basic purpose of the law has remained the same: to ensure the safety, efficacy, and quality of medical products in Japan.

The latest revisions to the PAL are meant to address the enhancements in the development and safety of new medical products in the 21st century. According to the Ministry of Health, Labor and Welfare (MHLW), the revised PAL is intended to

  • strengthen the safety measures related to medical devices,
  • enhance government regulations with respect to the application of biotechnology and genome technology in developing medical products and
  • fortify post marketing safety measures and the review system for approval and license while taking international conformity into account.

The revised PAL is a done deal, and now MHLW has developed or are in the process of developing many of the regulation level details. While the PAL is currently in high-level “Parliamentary Act” form, the ministry has produced regulation-level details through ministerial ordinances and enabling notifications.  The ordinances and notifications are always produced in Japanese; however, three key documents are now available, in English, to foreign manufacturers.  As a service to our global customers, BSI Japan provides these documents for download.

MHLW Ministerial Ordinance No. 169, 2004 (PDF size 140Kb),
Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-Vitro Diagnostic Reagents

This ordinance (No. 169) is the basis for the quality management system for manufacturers of medical devices.  The requirements of the quality management system are based on ISO 13485:2003, and this ordinance serves as the basis for GMP/QMS assessments for product certification in Japan.  Manufacturers should note that QMS certification, and not ISO 13485:2003 certification, is required for each medical device or family of medical devices.  Manufacturers who are currently registered by BSI to ISO 13485:2003 should have no difficulty in obtaining QMS certification under the Japan PAL.

MHW Ministerial Ordinance No. 2, 1961 (PDF size 119Kb), 
revised by MHLW Ministerial Ordinance No. 73, 2005, Regulations for Buildings and Facilities of Pharmacies, Etc.

This ordinance (No. 2) must be met by foreign medical device manufacturers in order to obtain accreditation by MHLW as a foreign manufacturer.  Compliance with the requirements of this ordinance is determined by the Pharmaceutical and Medical Devices Agency (PMDA) and not by any of the 3rd Party Registered Certification Bodies.

MHLW Ministerial Ordinance No. 136, 2004  (PDF size 63Kb),
Ministerial Ordinance on Standards for Quality Assurance for Drugs, Quasi-drugs, Cosmetics and Medical Devices

This ordinance (No. 136) describes the Good Quality Practices (GQP) applicable to all Market Authorization Holders (MAH).  Medical device manufacturers are required to formally designated a MAH for their products marketed in Japan and should familiarize themselves with the requirements of this ordinance as part of establishing and maintaining good relationships with their MAH.

For further information on Japan's Pharmaceutical Affairs Law and QMS requirements, please email us at japan.sales@bsigroup.com or contact BSI Japan on+81-3-6890-1177.


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