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.
Since its establishment, the Medical Devices Division (referred to as the MDD) has focused on three main areas: Technical dossier Evaluation, regulatory consultation services for medical device, and engaging in education and promotion efforts.
1. Review and Evaluation Services
Since 2006, the MDD has assisted the TFDA in conducting reviews for registration of medium and high-risk medical devices, including clinical trial evaluations (and GCP audits). Additionally, we address regulatory needs for emerging medical device industries, developing standards for pre-clinical testing, clinical evaluations, and drafting guidelines for clinical evidence.
2. Regulatory Science Consultation and Guidance
To foster the development of the medical device industry, we assist various stakeholders from academia, industry, and research sectors in integrating regulatory considerations early in the medical device development process. Leveraging accumulated domestic and international regulatory knowledge and years of evaluation and review experience, our focus is on the design and development stage of the lifecycle of medical device. Regarding manufacturers, we offer regulatory consultation services to businesses and research units for all stages of medical device from development to market launch. Our services encompass general consultations, advisory services for index cases, and paid consultation services.
3. Education and Outreach
Building on our expertise in review and regulatory science consultation, we actively engage in educational outreach within the industry. Our goal is to promote understanding of correct medical device regulatory requirements among manufacturers, corporate entities, and public associations. By enhancing the preparation of preclinical and clinical submission documents, we aim to elevate the knowledge base of medical device regulations in our country.
To date, the MDD continues to enhance its review capabilities and quality standards. Beyond this, we are committed to providing consultation and acting as a vital link between government regulatory bodies, academic researchers, and industry stakeholders. Our efforts are geared towards accelerating the growth of Taiwan's medical device industry.
