• Last updated：2024-08-13
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In accordance with the regulations of the Ministry of Health and Welfare, clinical trial institutions or trial sponsors shall file an application with the central governing authority and obtain its approval before initiating any clinical trial applications. The MDD is entrusted to evaluate clinical trial cases of medical devices, including the safety, effectiveness and ethical considerations of investigational medical devices to protect the rights, safety and well-being of subjects and consumers. For approval of medical device clinical trials in our country, please refer to the provisions of the "Good Clinical Practice for Medical Devices."