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Technical dossier review

The Medical Device Division(MDD) of the Center for Drug Evaluation(CDE) was established in 2006, engaging in the technical data review and evaluation of medical devices. The MDD is responsible for evaluating clinical trials and product technical files of medical devices for the Taiwan Food and Drug Administration (TFDA) of the Ministry of Health and Welfare (MOHW), including clinical protocols and study reports, registration, license extension and change of medical devices, to ensure the safety, effectiveness, and quality of medical devices to be used by domestic people.

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