A Struggle and Possible Solution to Deliver New Medical and Dental Devices to the Clinics in Japan

In the last decade, Japanese industries of medical devices have severely lost the international competition, and novel medical devices are mostly imported from foreign countries. Dental devices also show same tendency. Though several reasons are pointed out, the most well-known barrier is the severe regulation of pharmaceutical affaires. Thus device-lug and device-gap are commonly occurred in present medical and dental fields. Laser apparatus are also suffered from same problem. Only dental laser apparatus are successfully produced in Japan.In order to improve these conditions, government and PMDA announced the new action programs. From the point of academia, we propose the increase of man power about proper knowledge of regulatory science in dental field. Mutual understandings and wider cooperation among academia, clinician, dental industry and executive authority are essential in order to produce innovative products.