The new requirements in the amended Japanese Pharmaceutical Affairs Law (PAL) that relate to the approval and regulation of medical devices enter into force on 1 April 2005. The law is intended to increase the safety measures for medical devices by, among other things, separating manufacturing activities from distribution/marketing (“business”) activities and introducing a new risk-based classification system that is aligned with Global Harmonization Task Force (GHTF) rules. There will be two licences required: one business licence for distributor/marketer and one manufacturing licence for the manufacturing facility. Both licences have to be renewed every five years. We are working together with the Japanese Notified Body Nanotec Spindler Co., Ltd.
Please do not hesitate to contact us in case you need our help for the registration/certification of you medical devices for Japan.