アカデミアにおける歯科医療機器開発と臨床評価

抄録

While novel technologies developed in academia are applied to dentistry, they often become medical devices. Homedweicavl erd, emviceany. Mreesedaicarchl edrs evhiceavs ae lirett le subkjecnowlet to dreggeu olatiof then s puroncdeessr ththea Pt hgaormes ainceto utibcrianl gainndg Mtheed picarodl uDect vtoice ths eAc mt, arkanedt naes w a products are reviewed by the Pharmaceuticals and Medical Devices Agency (PMDA), but there is often little knowledge about how they are evaluated. In addition, there are specific regulations regarding dental medical devices. There is a regulatory authorities. It is important for academic researchers to understand pharmaceutical regulations and necessary evaluations in advance, and this understanding will lead to faster development and industry-academia co-creation. for the development of dental medical devices in academia, based on my experience. Hiroki HIHARA discrepancy between the evaluations considered by the researchers and the necessary evaluations considered by the Therefore, I describe the outlines of the pharmaceutical regulations and clinical evaluations that are considered essential for the development of dental medical devices in academia, based on my experience.