The Center for Drug Evaluation established its Medical Device Division in 2006, assembling a team with expertise in biological, biomedical and engineering science background. Physicians on the team also participated in the evaluation of medical devices. Under the what was then the Bureau of Pharmaceutical Affairs (predecessor to the TFDA). The division’s core responsibilities included assisting in the evaluation and registration review of medium to high-risk medical devices and clinical trial applications. Since then, as the division’s organizational structure developed steadily, efforts were made to expand and strengthen the capacity of the review team. In addition to physicians supporting the review process, the division also recruited physicians to full-time positions to bolster the review team’s capabilities. In 2017, considering the continuous growth and development of the division, two new teams were established to better manage project management and review operations, thus aligning with operational needs and enhancing efficiency. By 2022, to deepen the provision of regulatory science consultation and guidance services, the division was reorganized into three teams from the original structure. This restructuring aimed to specialize in technical assessment, consultation guidance, and project management. Since its inception, the team has expanded from its initial formation of six members to a professional team of over forty. Looking ahead, the MDD will continue to uphold its expertise in medical device regulatory science and support the industry, government, academia, and research sectors in their medical device development. We are committed to advancing regulatory science in the medical device industry to safeguard public health.