Pharmaceutical and Medical Device Agency (PMDA), Japan is responsible for the pre-market review of high-risk medical devices including highly-controlled (Class III and IV) devices. This article explains medical device regulation and premarket review based on the Japanese Pharmaceutical Affairs Law. Additionally, the PMDA review process and its expediting initiative. This information would make it possible to elaborate comprehensive strategy for the marketing approval from an early development phase, and thus lead to improve the medical device research and development.
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.
In order to deliver a new medical devices which are really useful to the field, it is required to be regulatory apply with sufficient material to ensure its usefulness. It is the shortest cut to be approved as a medical device. Problems of applicant's side and the reviewer side are pointed out, but in order to develop truly useful dental laser equipment, the efforts of manufacturers of course, and support from the society, and further promotion of the discussion with the government is necessary.