Device manufacturers should be able to introduce products to the Japanese market faster once the country expands its device review staff and improves good clinical practices for devices. The country also plans to promote the rationalization and simplification of clinical trials and approval reviews while securing the safety of devices, Japan’s Ministry of Health, Labour and Welfare said.
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) was established and came into service on April 1, 2004, under the Law for the Pharmaceuticals and Medical Devices Agency, as a consolidation of the services of the Pharmaceuticals and Medical Devices Evaluation Center of the National Institute of Health Sciences (PMDEC), the Organization for Pharmaceutical Safety and Research (OPSR/KIKO), and part of the Japan Association for the Advancement of Medical Equipment (JAAME).