Premarket Approval

　　　The Div. of Medical Devices at CDE was established in 2006. This new division was created as part of a national biotech program to enhance Taiwan’s regulatory environment, especially for the medical device industry, which is considered one of the major biotech areas with high potential and expectations in Taiwan. The major roles and missions of this division are two folds.

　　　For the protection of public health and the facilitation of the review process, CDE is delegated by the BPA of DOH to conduct technical review of clinical trial protocols and pre-market approvals of new medical device applications including In Vitro Diagnostics devices (IVD). The review is conducted based on the principles of regulatory science to evaluate the safety, effectiveness, quality, and risk/benefit of medical devices following standard review procedures.

　　　In response to the growing need for better regulations from the medical device industry, the division also provides assistance to the industry by drafting new guidance documents, organizing training workshops, and by providing pre-submission consultations. The division works closely with major regulatory agencies in Asia, Europe, and the United States to exchange review experiences and to stay up-to-date with current international regulatory practices. The goal of the division is to implement a transparent, efficient, and predictable review scheme, in harmonization with the international regulations, which serves to promote innovative technologies while protecting public health interests.