Medical Devices
Introduction
Technical Dossier Evaluation and Regulatory Consultations for Medical Devices

The Division of Medical Devices at CDE was established in 2006. It was created as a part of a national biotech program to enhance Taiwan’s regulatory environment, especially for the medical device industry, which was considered one of the major biotech areas with high potential and expectations in Taiwan. The service scope of the Medical Device Division including:

  • Technical Dossier Evaluation

    As commissioned by Taiwan Food & Drug Administration (TFDA), CDE conducts technical dossier evaluation on medium to high risk product submissions, as well as reviews on clinical trial protocols. At present, CDE assists government agencies in providing regulatory evaluations on medical device cases. And helps provide National Biotech Program with regulatory analyses on medical device cases. These efforts serve to ensure safety and effectiveness of pharmaceutical products on the market through sufficient pre-market technical dossier evaluations.

  • Regulatory Consultations

    In order to promote understanding of regulatory requirements and to facilitate product development, CDE provides early phase consultations and training programs to the medical device industry. As commissioned by TFDA, CDE prepares guidance documents for medical devices and promotes regulatory education by building medical device information database. Moreover, regulatory trainings and consultation services are also offered to medical device industry.