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

DOI
  • ISHIKAWA Isao
    Tokyo Medical and Dental University, Professor Emeritus Tokyo Women's Medical University, Institute of Advanced Biomedical Engineering and Science, Consultant
  • HARADA Naoko
    Tokyo Medical and Dental University, Graduate School, Section of Cariology and Operative Dentistry, Assistant Professor

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Other Title
  • 新しい医療機器を現場に届けるには
  • —From a point of academian view—
  • ―大学サイドからの観点―

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Abstract

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.<br>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.

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