Introduction
Meeting Quality Management System requirements and other regulations for the manufacture and sale of Medical Devices around the world can be complex and confusing. Japan’s Pharmaceutical Affairs Law (PAL) aims to harmonize requirements and reduce some of the conflicting demands by incorporating the guidance documents on the Global Harmonization Task Force (GHTF). This includes quality management system requirements based on ISO 13485:2003.

This guide will help you to identify the key PAL issues in order to prepare yourself for:
•Understanding
•Implementation
•QMS/GMP certification 

This guide has also been written with the understanding that your organization may currently be registered to ISO 13485:2003, or in the process of registration.

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