Page 18 - 2019食藥署年報(英文版)

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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
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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 to 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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