新しい医療機器を現場に届けるには

DOI
  • 石川 烈
    東京医科歯科大学名誉教授 東京女子医科大学先端生命医科学研究所顧問
  • 原田 直子
    東京医科歯科大学大学院医歯学総合研究科口腔機能再構築学講座う蝕制御学分野助教(歯科器材・薬品開発センター副センター長)

書誌事項

タイトル別名
  • A Struggle and Possible Solution to Deliver New Medical and Dental Devices to the Clinics in Japan
  • —From a point of academian view—
  • ―大学サイドからの観点―

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抄録

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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