The Medical Device Division (referred to as the MDD) was established in May 2006 and has since been assisting the Food and Drug Administration (TFDA) of Ministry of Health and Welfare (MOHW) with pre-market reviews, clinical investigation assessments, and specialized consulting services. In recent years, the division has expanded its scope to support government funding programs under major national biotechnology initiatives and biopharmaceutical research and development. This includes providing regulatory planning advice to relevant ministries and applicants involved in for individual medical device projects, and facilitating domestic growth of medical device industries. Additionally, the division offers regulatory consultation services to stakeholders from industry, academia, and research sectors, aiding manufacturers and research teams in navigating regulatory requirements to expedite product market entry.