Page 18 - 2020Taiwan Food and Drug Administration Annual Report

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I. Medical devices management framework

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. In response to the growing prospects of the medical device
industry in Taiwan, TFDA has established a Total Product Life Cycle (TPLC) management
policy for medical devices (Figure 1-7) that includes harmonization with international standards
and regulations, production source control, pre-market control, post-market surveillance,

management of pharmaceutical companies and product distribution channels, and provision
of professional counseling services. The purpose of the TPLC policy is effectively control
the safety, performance, and quality of medical devices, and to promote the developments of
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consumers, industry, and government.

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