Medical Devices～From Development to Reaching Patients～(What needs to happen for a medical device to get into the market)

摘要

Japan is one of the largest markets for medical devices in the world, and the Japanese government positions the medical industry as a key industry that will lead the Japanese economy. However, the market largely relies on imports, especially in the field of therapeutic devices. In order to ensure international competitiveness of the Japanese medical industry in the future, and to invent and develop innovative medical devices that will match the actual needs of the patients, collaborations amongst the academic, the medical, and the industrial communities are highly encouraged. The medical devices are classified into different categories according to their risk levels with respect to the human health and body, and their development paths differ accordingly, in terms of (but not limited only to) the clinical trial requirements and certification/regulatory submission paths. Entities (i.e. companies) that manufacture, import, sell, distribute, lease, and/or repair medical devices must also obtain licenses to do so. The present paper gives an overview of the medical device development, especially for those in the academia who may not be regularly exposed to such information.