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The division promotes researches related to chemical and physical properties, mechanical stability, biocompatibility and microbiological safety of medical devices and their materials in order to ensure their quality, performance and safety. In addition, their pilot manufacturing, conformity test and standard development are performed. In particular, the development and standardization of new test methods of medical devices are the most important subjects for their practical application, so that the researches based on regulatory science under the industry-government-academia collaboration have been strongly driven.