Part II Chapter 4. Medical Devices Management

Part II Chapter 4. Medical Devices Management

The medical device industry is poised to become Taiwan's leading biotech industry in terms of development potential, given its rapid developments in technology and growing demands for healthcare technologies due to the aging of Taiwan's society. In response to growing prospects of the medical device industry in Taiwan, the TFDA has established a Total Product Life Cycle (TPLC) management policy for medical devices (Figure 2-4-1) that includes harmonization with international standards and regulations, production source control, pre-market gatekeeping, post-market surveillance, management of pharmaceutical companies and product distribution channels, and provision of professional counseling services.