ISO 13485:2003 in Japan
This is from TUV Rheinland Japan
ISO 13485:2003 - Medical device- Quality management systems- Requirements for regulatory purposes has been published. ISO 13485 is the quality management system standard for design & development, production, selling and other activities of medical devices. It is internationally used as regulatory requirement for the medical devices, e.g., in EU, Canada, Australia. Revised Pharmaceutical Affairs Law (PAL) that will come into force in Japan in 2005 will require a legally registered manufacturer and ensuring confirming the quality system on the basis of ISO 13485.
TUV Rheinland has globally performed ISO 13485 certification for leading medical device manufacturers. TUV Rheinland performs ISO 13485 certification as required in the revised PAL.
Thsi looking for precise info
Laurie