Meeting quality management system (QMS) 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 of the Global Harmonization Task Force (GHTF). This includes quality management systems requirements based on ISO 13485.
To sell medical devices to Japan you must do more than be certified to ISO 13485. However, the requirements stipulated from the Ministry of Health, Labor and Welfare (MHLW) come from Ministerial Ordinance 169 and are based on ISO 13485.
The medical device manufacturer and their Market Authorization Holder (MAH) have the responsibility for product certification under PAL.
To become familiar with the regulatory requirements, visit our Japan Website.