Japan Pharmaceutical Affairs Law (PAL)
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 of the Global Harmonization Task Force (GHTF). This includes quality management systems (QMS) requirements based on ISO 13485:2003.
Access to Japanese Medical Device Market with BSI
To sell medical devices to Japan you must do more than register to ISO 13485:2003. However, the requirements stipulated from the Ministry of Health, Labor and Welfare (MHLW) come from Ministerial Ordinance 169 and are based on ISO 13485:2003.
The revised Japan Pharmaceutical Affairs Law (PAL) expands regulation of medical devices sold in Japan. Quality Management System (QMS) requirements have been established
incorporating ISO 13485:2003 and Global Harmonization Task Force (GHTF) principles. The 2005 revision allows BSI, as a Registered Certification Body (RCB), to certify lower risk Designated Controlled Medical Devices (Class II).
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 Asia Website. For further information on our schemes and services for medical devices in Japan, please contact us.
